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Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
University of California, San Francisco · Other
Who this trial is looking for
This trial is looking for adults aged 25-75 with Parkinson's disease who have not found relief from their symptoms through medications. Participants will receive a device that collects brain signals to help improve treatment for their movement and sleep problems.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 25 and 75 years old.
I have been diagnosed with Parkinson's disease.
I have not found enough relief from my symptoms with oral medications.
I have requested surgery for deep brain stimulation.
I have a normal brain MRI.
I do not have significant cognitive impairment.
I have a specific range of motor function scores.
I experience significant motor fluctuations.
You may not be able to join if
I have a bleeding disorder or uncontrolled high blood pressure.
I have a movement disorder caused by psychological factors.
I am pregnant or could become pregnant.
I have untreated significant depression.
I have mood issues that may affect my participation.
I need electroconvulsive therapy or have had certain brain surgeries.
I have had serious negative reactions to similar treatments.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to test a new way to treat Parkinson's disease (PD). Subjects will be implanted with deep brain stimulator (DBS) devices and electrodes placed under the scalp.
The main questions it aims to answer are:
* Is there a less invasive method to collect useful brain signals? Find out if these brain signals can be related to movement and/or sleep symptoms.
* How to use these…
The purpose of this study is to test a new way to treat Parkinson's disease (PD). Subjects will be implanted with deep brain stimulator (DBS) devices and electrodes placed under the scalp.
The main questions it aims to answer are:
* Is there a less invasive method to collect useful brain signals? Find out if these brain signals can be related to movement and/or sleep symptoms.
* How to use these brain signals to tailor adaptive deep brain stimulation settings for movement and/or sleep symptoms
Researchers will compare study derived adaptive DBS settings to subject's clinically programmed continuous DBS settings to see which is better at treating patients PD symptoms.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion criteria
1. Age 25-75.
2. Diagnosis of idiopathic PD.
3. Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist (Dr. Bledsoe).
4. Patient has requested surgical intervention with deep brain stimulation for t…
Inclusion criteria
1. Age 25-75.
2. Diagnosis of idiopathic PD.
3. Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist (Dr. Bledsoe).
4. Patient has requested surgical intervention with deep brain stimulation for their disorder or previous enrollment in sponsored IDE (G220241) to use Percept PC wired to subgaleal sensing, if patients have ongoing daytime fluctuations or sleep dysfunction despite cDBS optimization.
5. Normal preoperative brain MRI.
6. Absence of significant cognitive impairment (score of 24 or greater on the Montreal Cognitive Assessment (MoCA).
7. Signed informed consent.
8. Motor UPDRS-III off medication score 25 to 65 and a \>35% improvement with levodopa, predominant rigid/bradykinetic symptoms (ratio of off-medication UPDRS-III limb rigidity/bradykinesia scores to limb tremor scores of \>1.2).
9. Motor fluctuations despite optimized medical therapy with at least 2 hours per day of either "off" time, or "on" with dyskinesias.
10. Ability to comply with study follow-up visits for brain recording, testing of closed-loop stimulation, and clinical assessment.
Exclusion criteria
1. Coagulopathy, uncontrolled hypertension, heart disease, or other medical condition considered to place the patient at elevated risk for surgical complications.
2. Patient meets criteria for a psychogenic movement disorder.
3. Pregnancy: all women of childbearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
4. Significant untreated depression (BDI-II score \>20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS).
5. Any personality or mood symptoms that study personnel believe will interfere with study requirements.
6. Patient who requires electroconvulsive therapy, repetitive transcranial magnetic stimulation, or diathermy, implanted neurostimulators and MR-incompatible metallic implants, previous craniotomy on the side of the intended subgaleal implant, and drug or alcohol abuse.
7. Patients who experience adverse effects that are undesirable and detrimental to the health of subjects from DBS or other similar neurostimulators
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