Investigating Adaptive Deep Brain Stimulation in Parkinson's Disease Management (NCT06891781) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Investigating Adaptive Deep Brain Stimulation in Parkinson's Disease Management
104 participantsStarted 2026-08
Plain-language summary
The goal of this prospective, multi-center, randomized, double-blind, crossover clinical trial is to evaluate the effectiveness and safety of adaptive DBS (aDBS) and conventional DBS (cDBS) delivered through the AlphaDBS system, in levodopa-responsive Parkinson's disease subjects. Data from previous studies conducted in Europe indicate that the use of the AlphaDBS system is safe and effective in both aDBS and cDBS modes. However, such studies suggest that aDBS may lead to more ON-time without troublesome dyskinesias in some patients. The study is designed to first demonstrate safety of effectiveness of cDBS, then to directly compare effectiveness of aDBS relative to cDBS. Subjects enrolled in the study will undergo multiple visits to assess the improvement of PD symptoms and will be randomized to Mode 1 for three months, followed by Mode 2. At the end of Mode 2, subjects will select their preferred mode, which will be maintained for 3 additional months. Subjects will complete patient diaries at different time points to evaluate their symptoms throughout the day.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Is willing and capable of signing informed consent
. Is ≥18 years old
. Has been diagnosed with levodopa-responsive idiopathic Parkinson's disease
. Has a Hoehn and Yahr (H\&Y) scale stage of II or III when OFF medication at screening
. Exhibits motor fluctuations and PD-related symptoms that are not adequately controlled with medication, including motor complications of recent onset (\>4 months duration)
. Has been referred for bilateral STN DBS in accordance with local practice
. Must be a good surgical candidate for placement of a deep brain stimulator as judged by the DBS surgical team
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement in Good On Time (GOT)
Timeframe: After 3 months of follow up in cDBS as compared with preop baseline
. Montreal Cognitive Assessment (MoCA) score of ≥ 26 at the Baseline/Screening visit (when in "MedsON" state)
Exclusion criteria
. Has contraindications for DBS surgery, including any intracranial abnormality (e.g., generalized atrophy, vascular malformation, hydrocephalus, hematoma, cavernous or venous angioma, tumor or metastases, midline shift, etc.) or metallic implant (e.g., aneurysm clip, cochlear implant, etc.) or other clinically significant space-occupying lesion which in the opinion of the surgeon would impact the ability to target and place the leads or IPG
. Is not on a stable dose of levodopa anti-Parkinson's disease medication for at least 2 weeks prior to Screening/Baseline assessments
. Has any current major psychiatric disorder(s), such as Major Depressive Disorder, Bipolar I or II disorder, Schizophrenia, Schizoaffective Disorder, Delusional Disorder, Brief Psychotic Disorder, Obsessive-Compulsive Disorder, or any other current psychiatric condition that in the opinion of the investigator would confound the assessment of study endpoints, prevent proper data collection and/or compromise the subject's ability to participate, based on the psychiatric/psychological assessment at screening.
. A history of suicide attempt within 3 years of the screening visit or current active suicidal ideation as determined by a psychiatric/psychological evaluation
. Any medical condition, such as cognitive impairment, dementia, seizures, congestive heart failure, unstable angina, uncontrolled diabetes, renal failure requiring dialysis, or any other severe medical condition that could interfere with study procedures, confound the assessment of study endpoints, prevent proper data collection, or that, in the opinion of the investigator, would compromise the subject's ability to participate
. Confirmation of diagnosis of a terminal illness associated with survival \<12 months
. Needs repeated MRI scans
. Requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)