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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "At the end of this period, a telemedicine visit will be conducted to collect quality of life (QoL) questionnaires, related surveys, and a video-based modified MDS-UPDRS assessment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether patterned deep brain stimulation (pDBS) is safe and comfortable to use at home. DBS sends electrical signals to the brain. The study is for people with Parkinson's disease who have had stable DBS on both sides of the brain for at least 6 months.

The primary objective of the proposed pilot study is to assess the safety and tolerability of active patterned Deep Brain Stimulation (pDBS) when administered in a home setting for patients with Parkinson's disease (PD) who have had stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have DBS on both sides of the brain in an area called the STN or GPi, using the Boston Scientific Vercise Genus DBS System.
  • Have Parkinson's disease confirmed by a nerve and brain doctor with special training in movement disorders.
  • Have had stable DBS treatment for at least 6 months.

Who can't join

  • Have had brain or nervous system surgery other than DBS.
  • Have dementia, a condition that affects memory and thinking, whether or not it is linked to Parkinson's disease.
  • Have been diagnosed with atypical or secondary parkinsonism—conditions that cause Parkinson's-like symptoms—at any time after the DBS device was placed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

FL