RightFit
Not yet recruitingNot applicable

Automated Image-Guided Programming of Deep Brain Stimulation (DBS) for Parkinson's Disease

Quantitative Digitography to Evaluate the Efficacy of Image Guided Algorithmic DBS Programming

Who can join

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

Age
21 Years and older
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
  • "Participants are tested on these different settings across different motor tasks, including walking and finger tapping, as well as answering questionnaires."
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 study tests whether Illumina 3D, a computer program that chooses deep brain stimulation (DBS) settings, helps movement problems in Parkinson's disease. DBS uses an implanted device to send electrical signals to the brain. The study is for people with a new DBS device who are about to have it turned on for the first time; testing takes 1 or 2 days, then they return to their usual settings.

The goal of this clinical trial is to evaluate an automated deep brain stimulation (DBS) algorithm developed by Boston Scientific called Illumina 3D for motor symptoms in Parkinson's disease (PD). The main question it aims to answer is: Is this new automated algorithm effective for treating motor symptoms of PD. Fifteen participants are anticipated to be enrolled. Participants are individuals who recently were implanted with DBS in the subthalamic nucleus as part of their regular clinical treatment and are scheduled to have their DBS turned ON for the first time. In addition to their regular clinical visit when their DBS is turned ON by their clinician, participants are tested on DBS settings determined by Illumina 3D (an automated algorithm). Participants are tested on these different settings across different motor tasks, including walking and finger tapping, as well as answering questionnaires. The experiment is expected to last 1 or 2 days; this is not a longitudinal or long-term trial. Participants return to their usual DBS settings once they leave the clinic.

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

Eligibility

Who can join

  • Have Parkinson's disease.
  • Have a newly implanted Boston Scientific DBS device, or will get one soon.
  • Are willing to stop taking usual medicines when needed for study visits.

Who can't join

  • Have dementia, a condition that affects memory and thinking.
  • Are unable or unwilling to have DBS turned off for a short time.

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

Official eligibility criteria

Inclusion Criteria: * Diagnosis of Parkinson's disease (PD) * Newly implanted or soon to be implanted with deep brain stimulation (Boston Scientific device) * Willingness to withdraw from clinical medication regimen when necessary for research visits Exclusion Criteria: * Dementia * Unable or unwilling to come OFF DBS for a short period of time

Study sites (1)

CA