Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

Patterned deep brain stimulation delivered at home for Parkinson's

Official title: Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting

Run by University of Florida · NCT07410598 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment60 (estimated)
SponsorUniversity of Florida
Academic / other
Locations1 site (Gainesville, Florida)
StatusRecruiting
StartedMay 6, 2026
Main results expectedMarch 1, 2028
Study endsMarch 1, 2028
Registry record updatedJuly 6, 2026
Trial IDNCT07410598 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University of Florida
    Gainesville, Florida, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.