Patterned deep brain stimulation delivered at home for Parkinson's
Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting
This study will test whether three types of patterned deep brain stimulation can be used safely and comfortably at home in people with Parkinson's who already have stable bilateral STN or GPi Boston Scientific DBS systems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT07410598 on ClinicalTrials.gov |
What this trial studies
This pilot enrolls 60 people with Parkinson's who have had stable bilateral STN or GPi DBS for at least six months and uses the Boston Scientific Chronos Research Engine to deliver patterned stimulation at home. Participants are assigned to one of three parallel arms — biphasic DBS, nocturnal theta-burst DBS, or region-specific frequency alternation — and each is programmed with both their chronic clinical setting and an additional patterned setting at baseline. The patterned settings are delivered according to pre-specified schedules (for example, theta-burst at night or different frequencies at dorsal vs ventral contacts) while other clinical parameters are maintained. The primary focus is on monitoring safety, tolerability, and feasibility of home-delivered patterned stimulation.
Who should consider this trial
Good fit: Ideal candidates are people with Parkinson's disease who have had stable bilateral STN or GPi DBS using the Boston Scientific Vercise Genus system for at least six months and do not have dementia or atypical/secondary parkinsonism.
Not a fit: Patients who have dementia, atypical or secondary parkinsonism, prior neurosurgical procedures besides DBS, or who use a non-Boston Scientific DBS system are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, this approach could expand safe home-based DBS options and allow new stimulation patterns that may improve symptom control or comfort without more clinic visits.
How similar studies have performed: Some small clinic and laboratory studies of patterned stimulation (including biphasic and theta-burst approaches) have shown physiological effects or symptom signals, but delivering these specific patterns at home is largely novel and not yet widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Bilateral STN or GPi DBS with Boston Scientific Vercise Genus DBS System * Diagnosis of Parkinson's disease as confirmed by a movement disorders fellowship trained neurologist * Chronic stable DBS therapy, defined as having DBS therapy for at least 6 months Exclusion Criteria: * History of previous neurosurgical intervention aside from DBS * Diagnosis of dementia (whether primary or related to Parkinson's disease) * A diagnosis of atypical parkinsonism or secondary parkinsonism at any time after DBS implantation
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Joshua Wong, MD
- Email: joshua.wong@neurology.ufl.edu
- Phone: 352-294-5400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.