• Device-aided therapies for Parkinson’s disease (Subcutaneous Infusion, DBS, Focused Ultrasound, and Duopa) can be an effective option for many symptoms of Parkinson’s disease.

  • These options may be considered when a patient has exhausted several oral medications for PD, despite trying multiple medication adjustments with their neurologist or MDS.

  • It might be time to consider device-aided treatment options once a patient’s tremor, motor fluctuations (on/off), and/or dyskinesia become persistent and interferes with their quality of life.

  • The symptoms of Parkinson’s Disease are generally first treated with oral medications. The mainstay of treatment is a medication called carbidopa/levodopa. There are multiple medications clinicians may prescribe in addition to the carbidopa/levodopa to help a patient’s symptoms. These are often called adjuvant medications. You can read about the medications used to treat Parkinson’s Disease, as well as the many symptoms patients struggle with, elsewhere on the website.

  • Some patients, despite multiple medication adjustments with a neurologist or movement disorder specialist, struggle with PD symptoms. Around this time, the conversation about device-aided therapies begins.

    • PD symptoms:

      • Motor fluctuations, or wearing off between doses, where tremor, slowness, stiffness, and/or difficulty walking re-emerges between doses.

      • Dyskinesia, or excess wiggly involuntary movements, generally presents at the peak effect of carbidopa/levodopa.

      • Dystonia, or cramping and abnormal posture of feet or hands, are generally present during wearing off.

      • Medication refractory tremor, or tremor that persists throughout the day despite higher doses of levodopa.

  • Device-aided therapies are treatments beyond oral medications to treat PD. These use hardware, such as an electrode or a pump, to deliver treatment, such as electrical stimulation or medication, to help a patient’s symptoms.

For all device-aided therapies, the therapy will generally not make you better than when your medication is working at peak effect (best “on”). With all device-aided treatments, the goal is to have a patient function like they are at the peak effect of their medication, but for more of the day and without troublesome dyskinesia. The exception to this rule is that DBS and focused ultrasound may have a greater effect on tremor than levodopa.

Subcutaneous Infusions

  • Overview: 
    • Patients using this therapy wear a pump on their waist or in a holster. The pump is connected to a tube with a small needle tip that the patient or caregiver inserts just under a patient’s skin, usually on the abdomen. The patient has to change the infusion site every 1-3 days. The pump slowly administers medication just under the patient’s skin throughout the day. 
    • The continuous drug delivery prevents the highs and lows of medications that are experienced with intermittent oral medications. Adjusting the rate allows patients to get “on” and function well without excess dyskinesia. Patients can generally expect at least 2-3 fewer hours of “off” time during the day.
  • Risks: Patients may experience pain at the insertion site, particularly when changing the needle. Pain tends to be mild and resolves quickly. Sometimes the infusion pump site may become infected. This usually can be treated with antibiotics without stopping the therapy. Some patients may develop very small painless bumps (nodules) underneath the skin in previous infusion sites which tend to resolve over time with massage.
  • Invasiveness: This treatment is minimally invasive, as it just requires a small needle under the skin.
  • Reversibility: This treatment is easily reversible. The needle can be removed from the skin immediately. Patients can go on to receive more invasive therapies afterward if they are not functioning well.
  • There are three forms of subcutaneous infusion therapy, none of which are currently FDA-approved which are discussed more in the links below.

Deep Brain Stimulation (DBS)

  • DBS involves the surgical implantation of electrodes in the brain in areas important for the control of movement. Wires passing through the neck connect the electrode to a stimulator in the chest. The stimulator is a small pacemaker-like device that delivers a controlled electronic pulse to the brain. The stimulator is also called an implantable pulse generator (IPG).
  • DBS involves two surgeries. One where the electrodes are placed in the brain, and a second to place the IPG. After the surgeries, a patient meets regularly with their neurologist to determine the correct amount of electrical stimulation settings to improve PD symptoms. At this time, their oral medications for PD will be adjusted and reduced as well.
  • Patients who receive electrodes bilaterally have about 50% reduction in “off” severity, about 80-90% reduction in dyskinesia, PD medication reduction, and increased “on” time by up to 5-6 hours per day.
  • Risks: The risks of the surgical procedure are hemorrhage, or bleeding in the brain, which is a type of stroke. This risk is 1 to 2% for each side of the brain operated on. Infection may occur in up to 5% of patients at some time after surgery, usually involving the hardware outside of the brain. The DBS device may stop working due to breaks in the wiring that connects the electrode to the pacemaker-like device in the chest or other hardware problems. This risk is less than 5% in one’s lifetime. This would require additional surgery to replace or fix the DBS hardware. Some patients have reduced clarity of speech, a decline in memory and thinking, or worsening of freezing of gait or balance after DBS. These risks vary from patient to patient.
  • Invasiveness: This is an invasive therapy, requiring two surgical procedures.
  • Reversibility: DBS is somewhat reversible in that the electrical stimulation can easily be turned off or adjusted. Removing the hardware from the body would require surgery and is generally only done due to hardware breaking or infection. 

Focused Ultrasound (FUS)

  • Focused ultrasound (FUS), is a procedure that uses sound waves to heat up and destroy part of the brain important in movement control to improve tremor, motor fluctuations, and/or dyskinesia. This is a single procedure in which the effects on PD symptoms are immediate and are not able to be adjusted afterward. There is no hardware implanted in the brain. The treatment is only approved to be performed on one side of the brain, so only improves symptoms on one side of the body. Performing the procedure on both sides of the brain is done off-label for some patients and involves greater risk.
  • The effects of focused ultrasound are similar to that of DBS. Patients usually see a reduction in tremor by about 50%. This varies based on the location of the lesion. There is not enough data at present to give an estimate of “off” time reduction, though studies of this are ongoing
  •  Risks: Some side effects are temporary due to the procedure and these include pain, numbness, nausea, and headache. 
  • Long-term or permanent side effects occur when the area destroyed by FUS extends outside of the intended target. These include difficulty with walking, (4% of patients), numbness, which occurs (9% of patients), or weakness (2% of patients). Some patients have a waning of the effect of this treatment over time. There is also the risk of a poor outcome in that providers are unable to adjust the lesion after it is made, even if it does not improve a patient’s symptoms or if it causes side effects. This is a recently developed treatment and has not been used frequently, so we are still learning about the long-term effects of the surgery. There is very limited data regarding using this treatment on both sides of the brain to improve symptoms on both sides of the body.
  • Invasiveness: This is a single invasive procedure requiring brain surgery.
  • Reversibility: FUS is irreversible and cannot be adjusted over time.

Duopa

  • Duopa therapy is a form of carbidopa/levodopa delivered in gel form (called enteral suspension) directly to where the medication is absorbed in the small intestine.
  • Before Duopa may be started, a patient needs to get a minor surgery to make a small hole, called a stoma, in the stomach wall to place a tube in the intestine. This tube is connected to a pump worn in a vest, holster, or fanny pack. The pump then delivers the gel form of levodopa directly to the intestine through this tube.
  • This device is effective because it is a continuous, steady delivery of drugs throughout the day as opposed to the highs and lows that occur with intermittent oral medications. This generally results in a reduction in off time by at least 2-3 hours.
  • Patients, together with their neurologist, determine an appropriate continuous dose to provide most of the daily medication as well as an extra dose to be given if needed for unexpected wearing-off. At the same time, oral medications are reduced or discontinued.
  • The Duopa pump is somewhat large (about 20 cm x 9 cm x 2 cm) and weighs about 350 g, not including the medication cassette.
  • Risks: 
    • Procedure-related: Patients generally experience pain after the procedure requiring pain medications for a few days. There is a small risk of air or infection in the abdominal cavity which occurs in less than 5% of procedures. The patients and providers generally let the stoma heal for a few days before starting Duopa therapy.
    • Device-related: The tube may break, become blocked, or move which would require tube replacement. The stoma may become infected which usually resolves with topical antibiotic treatment, but may require oral antibiotics, and very rarely requires IV antibiotics.
  • Invasiveness: This therapy is invasive as it requires outpatient surgery to place the stoma and tube in the stomach. This surgery is somewhat less invasive than brain surgery and patients generally return home the same day as the procedure.
  • Reversibility: The pump can be turned off easily and quickly. The PEG-J tube procedure can be easily reversed if necessary, by just removing the tube. The stoma heals within weeks without lasting effects.

  • The specific device-aided therapy chosen must be customized to a patient’s particular symptoms. Some symptoms only improve with a specific device-aided therapy. For example, troublesome tremor despite aggressive treatment generally responds only to DBS or FUS.

  • There may be advantages to starting with the less invasive and more easily reversible device-aided therapies. This may allow a patient to function well without exposure to more severe side effects. Patients may always try additional more invasive device-aided therapies in the future if necessary.

  • Motor fluctuations: This is when patients experience “off” time, or worsening of PD symptoms (tremor, stiffness, slowness), between doses despite taking at least 4-5 doses of levodopa daily. Levodopa should also be combined with two or three trials of additional medications when wearing off is problematic. Additional medications include MAO-B inhibitors (rasagiline, selegiline), COMT inhibitors (entacapone, tolcapone, opicapone), and dopamine agonists (pramipexole, ropinirole, rotigotine), or istradefylline. There is no hard and fast rule about how much “off” time a patient must experience for device-aided therapies to be appropriate. Generally, most patients considering device-aided treatment experience at least 2-3 hours of “off” time per day, but some may experience more or less.

  • Dyskinesia: This is excess, wiggly, involuntary movements that are troublesome despite adjustment of a patient’s levodopa medications and trying amantadine or GoCovri.

  • Medication refractory tremor: This is tremor that is bothersome and interferes with a patient’s daily activities despite high doses of levodopa, at least 400-500 mg per dose, in addition to another medication such as an anticholinergic (like Artane or amantadine), clozapine, or propranolol. These patients may benefit from DBS or Focused Ultrasound. They will generally not benefit from Duopa or subcutaneous infusions more than from oral levodopa.

indications-for-parkinson's-device-aided-therapies

If you have troublesome tremor, which is not responding to high doses of levodopa and interfering with day-to-day activities, then you may wish to consider device-aided therapy.

 If you’ve tried multiple doses of levodopa and still have troublesome OFF time during the day, it might be time to consider device-aided therapies which can reduce the amount of OFF time and/or dyskinesia.

parkinson's-disease-pump-therapy-vs-surgery

How do you choose which device-aided therapy may be right for you? Learn how memory, balance, and freezing of gait may be affected by device-aided therapies.

   Choosing between device-aided and surgical therapies should be discussed with your doctor in regards to Parkinson’s symptoms, side effects, risks, comfortability, reversibility, etc.

parkinsons-disease-invasiveness-vs-reversibility
Subcutaneous Infusion Duopa Intestinal Gel Focused Ultrasound Deep Brain  Stimulation
Reversibility  Easily and completely reversible. Requires the removal of a needle Pump can be easily and immediately turned off. Tube can be removed and stoma heals within weeks. Non-reversible Electrical Stimulation can be easily and immediately turned off. Removal of the hardware in the brain would require additional surgery
Invasiveness Minimally invasive. Requires the insertion of a small needle under the skin. Mildly invasive. Requires an outpatient surgery to insert a tube in the stomach and intestine. The surgery is minor and patients usually return home the same day. Markedly invasive. Requires brain surgery to create a lesion in the brain. Patients generally return home the same day or next day. Markedly invasive. Requires brain surgery to insert the electrodes in the brain and an additional minor surgery to implant the IPG in the chest.
Adjustability Yes. Dosage can be adjusted. Some pumps allow for an extra dose function for unpredictable wearing off. Yes. The continuous dose of levodopa can be adjusted during the day, as well as the extra dose for unpredictable wearing off. No, not adjustable Yes, extensive programming to adjust the amount of electrical stimulation is included in this therapy.
Surgery No Yes (minor surgery) Yes (minor surgery) Yes (two major surgeries)
Effect on Cognition None None Unknown Potential Decrease
Components or Hardware Infusion Needle Tubing Stoma Tubing None Electrodes IPG
deep-brain-stimulation-parkinson's-disease
deep-brain-stimulation-parkinson's-disease

Deep brain stimulation (DBS) is a treatment for neurological conditions such as Parkinson’s disease, essential tremor, and epilepsy. DBS was first approved for the treatment of PD in 1997. DBS involves the surgical implantation of an electrode in the brain in an area important for the control of movement, specifically in a region called the globus pallidus internus (GPi) or the subthalamic nucleus (STN). Wires passing through the neck connect the electrode to a stimulator in the chest. The stimulator is a small pacemaker-like device that delivers a controlled electronic pulse to the brain.

Two regions in the brain may be chosen for electrode placement: the subthalamic nucleus (STN) or the globus pallidus internus (GPI). The area chosen depends on a patient’s symptoms. Both areas are very effective for a patient’s tremor and slowness. A clinician may be more likely to choose the STN if a patient experiences many adverse effects from carbidopa/levodopa such as excess dyskinesia. Stimulation of the STN often allows for greater medication reduction than stimulation of the GPi. There is some data to suggest that stimulation of the GPi leads to fewer problems with language and cognition. There are many ongoing studies that will help refine target choices for individual patients.

  • DBS is effective in treating the symptoms of Parkinson’s Disease such as slowness of movement, tremor, dystonia, or other symptoms that respond well to carbidopa/levodopa without causing excess involuntary movements, or dyskinesia.

  • Before ensuring a patient is appropriate for DBS, a clinician usually performs a “Levodopa Challenge Test” with a patient. During the test, the patient comes to the clinic without taking any medications. Over a few hours, the patient is given carbidopa/levodopa and repeatedly examined to evaluate the effect of the medications. Generally, the effect seen in the levodopa challenge test is a good indicator of the effect to expect from DBS. The one exception to this rule is medication refractory tremor. Often DBS is more effective for tremor than carbidopa/levodopa.

  • DBS stimulation is continuous, so it is very effective at treating motor fluctuations or the roller coaster of “on” and “off” symptoms many patients struggle with.

  • Risks of surgical procedure or hardware malfunction: The main risk of surgery is hemorrhage, or bleeding in the brain, which is a type of stroke. This risk is 1 to 2% for each side of the brain operated on. Infection may occur in up to 5% of patients at some time after surgery but most commonly in the first three months post-operatively. Generally, the infection involves the scalp or skin and infrequently involves the brain. Usually, patients can be treated with antibiotics, and sometimes hardware must also be removed temporarily, but rarely does the electrode in the brain need to be removed due to infection. The DBS device may stop working due to breaks in the wiring that connects the electrode to the pacemaker-like device in the chest. This risk is less than 5% in one’s lifetime. This would require additional surgery to replace or fix the DBS hardware.

  • Problems with speech: Some patients have reduced clarity of speech after DBS

  • Cognitive effects: A small number of people with PD have experienced a decline in memory and thinking after DBS surgery. This is why DBS is not appropriate for those patients with dementia.

DBS is not a cure for Parkinson’s Disease and it does not slow PD progression. It is generally not helpful for certain symptoms of PD such as problems with swallowing, speech, memory and thinking, balance, or freezing of gait.

  • Patients with Parkinson’s Disease for at least five years. DBS is not effective for disorders such as MSA, PSP, or CBD which mimic PD early in the disease.

  • Patients with “on/off” fluctuations despite consistent and regular medication dosing and despite trying additional medications to improve this.

  • Patients with troublesome dyskinesia despite medication adjustments.

  • Patients with troublesome dystonia despite medication adjustments.

  • Patients unable to tolerate carbidopa/levodopa due to side effects.

  • Patients with significant tremor that is not well controlled with medication, even despite medical management by a movement disorders specialist.

  • Patients without significant problems with memory and thinking that affect day-to-day life (dementia)

  • Focused Ultrasound:

    • DBS electrodes do not destroy healthy brain tissue. Instead, they create a temporary electrical signal that disrupts tissue activity. Focused ultrasound destroys brain tissue, creating a lesion in the brain.

    • DBS electrical stimulation can be adjusted over time as the symptoms of PD progress. Focused ultrasound cannot be adjusted after the initial procedure.

    • DBS requires significant programming after surgery and a time commitment for a patient and clinician. Focused ultrasound is a single procedure.

    • DBS requires a major brain surgery and a minor surgery. Both surgeries require anesthesia. Focused ultrasound requires one major brain surgery. The anesthesia required is minimal.

    • DBS is approved for both sides of the brain to improve symptoms on both sides of the body. Focused ultrasound is only approved for one side of the brain, to improve symptoms on one side of the body.

  • Duopa intestinal gel:

    • DBS uses electrical stimulation in the brain to improve PD symptoms. Duopa uses a continuous infusion of levodopa to improve these symptoms.

    • DBS requires a major brain surgery and a minor surgery. Duopa requires a minor stomach surgery to implant the tube.

    • Both DBS and Duopa can be adjusted over time to improve PD symptoms as the disease progresses.

    • DBS has a potential risk of worsening cognition. This is not true of Duopa.

  • Subcutaneous levodopa:

    • DBS requires surgeries that are not required for subcutaneous levodopa infusions.

    • DBS requires minimal continual care from a patient after surgery. Subcutaneous levodopa infusion sites need to be changed regularly by the patient.

    • DBS is somewhat reversible in that stimulation can easily be turned off. Removing the hardware from the body would require surgery. Subcutaneous levodopa is easily reversible in that the catheter can be immediately removed from the skin.

dbs-timeline-parkinsons-disease
focused-ultrasound-parkinson's-disease

Focused ultrasound (FUS), also called high-intensity focused ultrasound, is a procedure that uses sound waves to treat some conditions. The sound waves heat up and destroy tiny patches of your body tissue without affecting the surrounding tissue. Similar to how a magnifying glass can focus beams of light on a single point, focused ultrasound uses an acoustic lens to concentrate multiple sound waves on a point in the body. Your providers use magnetic resonance imaging (MRI) to guide the waves and target the area for treatment. In Parkinson’s Disease, this area of treatment is the subthalamic nucleus (STN) or the globus pallidus internus (GPI).

Focused ultrasound allows your providers to target areas deep in the body, such as the brain, without an incision. These areas can be very small (≤1×1.5mm) and targeted with extreme precision and accuracy. There is no hardware implantation, use of radiation, risk of infection, or bleeding with the focused ultrasound procedure.

Patients recover quickly. Because there are no incisions and general anesthesia is unnecessary, patients usually go home the same or the next day after the procedure. Physicians can determine if treatment is working in real-time during the procedure as well as stop immediately if adverse effects occur.

focused-ultrasound-parkinson's-disease

  • Preparation:

    • Your head will be shaved on the morning of the procedure to allow good contact between your head and the ultrasound.

    • You will be given some medicine through an IV to keep you comfortable during the procedure.

    • Your head will be placed in a head frame to keep your head steady and prevent it from moving. Next, a silicone membrane will be placed on top of your head. The membrane seals the space where cold water will circulate between your scalp and the helmet of the device. The water barrier helps keep your scalp cool and makes sure there is adequate contact between your head and the ultrasound equipment.

    • You will lie on an MRI bed, which slides in and out of the scanning area of the machine. The head frame is locked into position on the bed so you cannot move your head. Next, several scans will be taken of your brain. These scans help your physicians identify the area to be treated and the specific target area to aim the ultrasound waves.

    • Before treatment begins, you may be asked to draw spirals or write your name or perform certain hand and finger movements so your medical team can assess your tremor. You will be asked to repeat these tasks during various stages of treatment to see if the ultrasound is relieving your tremors.

  • Treatment:

    • Treatment begins with several short ultrasound pulses aimed at the target area. These low-energy (non-treatment level) pulses are administered to confirm that the proper target has been located.

    • Once the accuracy of the target is confirmed by MR images, the ultrasound energy is gradually increased over a series of stages. At each stage, the temperature of the targeted tissue is checked and MR images confirm that the procedure is continuing as planned. The MR images provide real-time feedback so the surgeon can make any needed adjustments.

    • You will be asked how you are feeling and will repeat hand and finger tasks to check treatment progress. Once your tremor is improving the ultrasound energy is increased so a small lesion forms.

    • You will be awake during the entire procedure inside the MRI and will be able to speak to your medical team. You will be given an emergency stop button to hold during the procedure. If you are experiencing pain or other adverse effects, you can push the stop button at any time.

  • Afterward:

    • The entire procedure, from preparation to getting off the table, takes about 3 to 4 hours.

    • After the procedure, you will move to a recovery room for observation. You may go home the same day or remain in the hospital for 24 to 48 hours. Your doctor will let you know when you can leave and when you need to return for a follow-up visit.

Focused ultrasound can be helpful for some of the symptoms of Parkinson’s Disease, predominantly tremor. The procedure is only approved for one side of the brain at present, so tremor would only improve on one side of the body.

Focused ultrasound is not a cure for Parkinson’s Disease and it does not slow PD progression. The procedure is not adjustable. It is generally not helpful for certain symptoms of PD such as problems with swallowing, speech, memory, and thinking, balance, or freezing of gait.

  • Temporary side effects of the procedure: The most common temporary side effects after the Focused Ultrasound procedure include burning pain, nausea, headache, temporary mild-to-moderate numbing and tingling in fingertips or lips, temporary unsteadiness in walk, balance problems, and temporary speech or swallowing problems. The side effects could start several days or weeks after treatment.

  • Long-term potential risks of Focused Ultrasound: After the procedure, some patients experience longer-term ( ≥ 3 months or longer) or permanent (in about 10-15% of patients) muscle weakness of the limb or face on the targeted side of the body (2%), unsteadiness/imbalance/difficulty with walking (4%), or numbness or tingling in the limb or face of the targeted side of the body (9%).

  • Risk of poor outcome: Providers are unable to adjust the lesion from the focused ultrasound procedure after it is made, even if it does not improve a patient’s symptoms or if it causes side effects.

  • Focused ultrasound is not very common and additional research is needed to establish the long-term procedure benefits and risks

  • A patient with troublesome tremor despite adjustment of their medication regimen with a movement disorders specialist, and who is unable to tolerate or decides against DBS.

  • This procedure is not recommended for patients with very thick skulls or those who will have difficulty undergoing an MRI.

  • DBS

    • Focused Ultrasound is a single procedure that does not require general anesthesia and patients are often able to go home that day. DBS requires two brain surgeries.

    • Focused ultrasound creates a hole in the brain. DBS creates an electrical current that disrupts the activity of brain tissue.

    • The effects of the procedure are immediate and cannot be adjusted over time. The effects of DBS can be adjusted over time. Often significant time is spent with a movement disorders specialist over months to fine-tune stimulation settings. These settings can be changed if necessary, even years later.

    • Focused ultrasound is irreversible. DBS can be turned off immediately. The electrodes can be removed if necessary, though this requires additional surgery.

  • Duopa

    • Focused ultrasound is a single procedure that does not require general anesthesia. Placement of the PEG-J tube is a single procedure that requires more anesthesia. Patients are often able to go home the same day after either surgery.

    • Duopa requires adjustment with a neurologist to set the continuous dose, extra dose, and morning dose. These settings can be changed if necessary, even years later. The effects of focused ultrasound are immediate and cannot be adjusted over time.

    • With Duopa, the PEG-J tube can be easily removed and the stoma heals within days. Focused ultrasound is irreversible.

  • Subcutaneous levodopa

    • Focused ultrasound is a major medical procedure involving brain surgery. Subcutaneous levodopa is less invasive, as it just requires the insertion of a small needle under the skin.

    • Subcutaneous levodopa infusion requires adjustment with a neurologist to set the continuous dose, extra dose, and morning dose. These settings can be changed if necessary, even years later. Focused ultrasound is a single procedure, effects are immediate and cannot be adjusted.

duopa-therapy-parkinsons-disease

Duopa therapy is a form of carbidopa/levodopa delivered in gel form (called enteral suspension) directly to where the medication is absorbed in the small intestine.  Before Duopa may be started, a patient needs to get a minor surgery to make a small hole, called a stoma, in the stomach wall to place a tube in the intestine. A pump then delivers the gel form of levodopa directly to the intestine through this tube. Duopa is the same active ingredient as the oral carbidopa/levodopa. It is helpful to improve absorption of the medication and reduce “off” time by delivering the drug directly to the small intestine.

There are 3 components to Duopa: 1. PEG-J Tube: Delivers medication into the body, directly through the intestine. To clean the tubing and prevent blockages, it should be flushed with a syringe before and after every pump use. Routine care will vary depending on the type of PEG-J tubing used. 2. Cassette: Contains the gel Carbidopa/Levodopa (2,000mg). A new cassette must be used daily, and discard any leftover medication. One cassette can be used up to 16 hrs. a day. Some patients may need up to 2 cassettes per day. Cassettes must be stored in the refrigerator. 3. Duopa Pump: The pump is programmed for individual needs. Pump settings include 3 doses: A large morning dose to get to an “on” state. Then switches to a lower continuous dose each hour to maintain the “on” state. Lastly, an extra dose is prepared as needed for unexpected “off” time.

  • Once your neurologist determines that Duopa therapy is appropriate for you, you will meet with a GI specialist to discuss the PEG-J tube procedure. If you have had certain surgeries on your abdomen, such as bariatric surgery or removal of part of your intestines, then you may not be eligible to receive Duopa.

  • The procedure usually lasts about an hour, which includes your time being placed under anesthesia. The GI specialist will insert an endoscope through your mouth that goes down your throat and into your stomach. They will use the endoscope to visualize and locate the correct place for the PEG-J tube, which will be threaded through the skin of your abdomen with a needle and secured in place. Most hospitals allow you to go home on the same day as the procedure.

  • Your neurology provider will calculate what your pump settings will be based on what you are currently taking in pill form. They also may bring you in for an office visit to titrate, or find the right balance for, your settings. Often your neurologist, nurse or PA will allow your stoma to heal for a few days to a few weeks before starting to administer the gel. During this time, you will take your medications in pill form like you did before surgery.

  • Prior to the procedure, your neurologist, nurse or PA will arrange an educational session on how to care for your stoma and tube, as well as how to operate and maintain your pump. It will be important to care for your stoma on a daily basis. This will involve keeping your stoma clean and moving your tube a small amount every day.

Duopa allows for continuous infusion of levodopa for up to 16 hours per day. Your continuous rate settings will provide most of your daily medication, and you may give yourself extra doses with the pump if needed. Generally, symptoms do not improve beyond what a patient considers good “on” time before Duopa therapy.

Some people choose to continue their other Parkinson’s medications (such as dopamine agonists or amantadine), although you often can stop these medications once you have the pump. At night, you can expect to take your oral medication as normal.

Duopa is not a cure for Parkinson’s Disease and it does not slow PD progression. Duopa generally does not help any Parkinson’s disease symptoms that do not improve with your best medication “on” time.

  • Risks of the procedure and device: movement or dislocation of the tube, infection, redness at the insertion point, bleeding, blockage, air or infection in the abdominal cavity and pump failure.

  • The side effects of treatment with the gel infusion of levodopa are the same as those for the pill form and include nausea, orthostatic hypotension, dyskinesia, dry mouth, constipation, confusion, and hallucinations.

  • Patients with advanced Parkinson’s disease who respond well to oral carbidopa/levodopa, but experience significant motor fluctuations. These patients generally have more than three hours of “off” time despite treatment with another class of medications such as MAO-B inhibitors or dopamine agonists.

  • Patients who have to take their medications very frequently and have difficulty maintaining a regular dosing schedule

  • Patients that do NOT take nonselective monoamine oxidases (MAO) inhibitors such as linezolid, phenelzine, or isocarboxazid.

  • DBS

    • DBS surgery is more intensive than that required for Duopa. For some patients where brain surgery is too risky, Duopa may be a reasonable alternative.

    • The PEG-J tube procedure for Duopa can be easily reversed if necessary, by just removing the tube. DBS stimulation may be shut off easily, but removing DBS electrodes requires additional surgery.

    • Duopa may reduce more of a patient’s daily pill requirement than DBS, though this varies depending on a patient’s medications and response to DBS.

    • Some patients have both DBS and Duopa, so it is important to remember that having one does not rule out the other and that the two therapies can be used in combination.

  • Focused Ultrasound

    • Focused ultrasound is a single procedure that does not require general anesthesia. Placement of the PEG-J tube is a single procedure that requires more anesthesia. Patients are often able to go home the same day after either surgery.

    • Duopa requires adjustment with a neurologist to set the continuous dose, extra dose, and morning dose. These settings can be changed if necessary, even years later. The effects of focused ultrasound are immediate and cannot be adjusted over time.

    • With Duopa, the PEG-J tube can be easily removed and the stoma heals within days. Focused ultrasound is irreversible.

  • Subcutaneous LD

    • Duopa requires a medical procedure to insert the PEG-J tube. Subcutaneous levodopa is less invasive, as it just requires the insertion of a small needle under the skin.

    • Both Duopa and subcutaneous levodopa infusion requires adjustment with a neurologist to set the continuous dose, extra dose, and morning dose. These settings can be changed if necessary, even years later.

    • Both therapies rely on the medication levodopa for their effect.

    • Both procedures are completely reversible. The stoma required in Duopa may take slightly longer to heal when compared to removing a needle for subcutaneous therapy.

duopa-components-parkinson's-disease
parkinson's-disease-subcutaneous-infusions

Subcutaneous Infusion therapy is currently available only by participating in research studies, although FDA approval for one of these devices is expected in the next year or so.  This is a pump the patients wear on their waist connected to a catheter inserted just under a patient’s skin, usually on the abdomen, which slowly administers medication to the patient.

Generally, a patient together with their clinician determines a continuous infusion rate that works well for them, and can administer small extra doses should they wear off unexpectedly.

Usually, depending on the specific pump used, the patient has to change the infusion site daily to every three days. This is fully reversible, in that should a patient decide to discontinue treatment, they can take the catheter out of the skin and there are no lasting effects of the treatment.

parkinson's-subcutaneous-infusions-timeline

  • Subcutaneous therapy allows for continuous infusion of medication throughout the day. The continuous rate settings will provide most of the daily medication, and you may give yourself extra doses with the pump if needed. Generally, symptoms do not improve beyond what a patient considers good “on” time before subcutaneous therapy.

  • Some people choose to continue their other Parkinson’s medications (such as dopamine agonists or amantadine), although some patients may be able to stop these medications.

  • Patients may experience pain at the insertion site, particularly when changing the needle. Pain tends to be mild and resolves quickly. The main more serious side effect is an infection at the infusion pump site. Some patients may develop very small painless bumps (nodules) underneath the skin in previous infusion sites as well.

  • The side effects of treatment with subcutaneous medication are the same as those for the sublingual and intermittent subcutaneous injection form and include nausea, subcutaneous nodules orthostatic hypotension, dyskinesia, sleepiness, confusion, and hallucinations.

Subcutaneous infusion therapy is not a cure for Parkinson’s Disease and it does not slow PD progression. It generally does not help any Parkinson’s disease symptoms that do not improve with your best medication “on” time.

  • Patients with advanced Parkinson’s disease who respond well to oral carbidopa/levodopa, but experience significant motor fluctuations. These patients generally have more than three hours of “off” time despite treatment with another class of medications such as MAO-B inhibitors or dopamine agonists.

  • Patients who have to take their medications very frequently and have difficulty maintaining a regular dosing schedule

  • Patients that are hesitant to try one of the other device-aided therapies due to the procedure risks or due to problems with reversibility.

  • DBS

    • DBS requires surgeries that are not required for subcutaneous infusions.

    • DBS requires minimal continual care from a patient after surgery. Subcutaneous infusion sites need to be changed regularly by the patient.

    • DBS is somewhat reversible in that stimulation can easily be turned off. Removing the hardware from the body would require surgery. Subcutaneous is easily reversible in that the catheter can be immediately removed from the skin.

  • Focused ultrasound

    • Focused ultrasound is a major medical procedure involving brain surgery. Subcutaneous levodopa is less invasive, as it just requires the insertion of a small needle under the skin.

    • Subcutaneous infusion requires adjustment with a neurologist to set the continuous dose, extra dose, and morning dose. These settings can be changed if necessary, even years later. Focused ultrasound is a single procedure, effects are immediate and cannot be adjusted.

  • Duopa

    • Duopa requires a medical procedure to insert the PEG-J tube. Subcutaneous levodopa is less invasive, as it just requires the insertion of a small needle under the skin.

    • Both Duopa and subcutaneous levodopa infusion requires adjustment with a neurologist to set the continuous dose, extra dose, and morning dose. These settings can be changed if necessary, even years later.

    • Both therapies rely on the medication levodopa for their effect.

    • Both procedures are completely reversible. The stoma required in Duopa may take slightly longer to heal when compared to removing a needle for subcutaneous therapy.