Simplified, Scalable, 24-hour Adaptive DBS in Parkinson's Disease
ConditionPD - Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
Qualifiers
Age 25-75.
Diagnosis of idiopathic PD.
Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist (Dr. Bledsoe).
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.
Disqualifiers
Coagulopathy, uncontrolled hypertension, heart disease, or other medical condition considered to place the patient at elevated risk for surgical complications.
Patient meets criteria for a psychogenic movement disorder.
Pregnancy: all women of childbearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
Significant untreated depression (BDI-II score >20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS).
Trial design
Treatments tested in this trial
- Medtronic Percept Deep Brain Stimulation (cDBS)
- Medtronic Percept Deep Brain Stimulation (daytime aDBS)
- Medtronic Percept Deep Brain Stimulation (nighttime aDBS)
Treatment groups
24 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of California, San Francisco
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov