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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorStanford University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Dementia

Unable or unwilling to come OFF DBS for a short period of time

Trial design

Treatments tested in this trial

  • Shame Control (Baseline)
  • Standard of Care Deep Brain Stimulation
  • Illumina 3D Deep Brain Stimulation
  • Illumina 3D Deep Brain Stimulation Reduced Amplitude
  • Illumina 3D Deep Brain Stimulation Higher Amplitude

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

Stanford University

Lead sponsor

Boston Scientific Corporation

Collaborator