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 range18 Years
SexALL
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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
✓. 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
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
✕. 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)