Bipolar DBS and brain imaging to improve balance and walking in Parkinson's
Imaging Core Aim 2, and Udall Project 2 Aim 2
This project will test whether using bipolar deep brain stimulation settings together with MRI can help people with Parkinson's who have balance problems and freezing of gait.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06998303 on ClinicalTrials.gov |
What this trial studies
This interventional protocol enrolls adults with Parkinson's disease who already have an MR‑compatible Medtronic Percept or Percept RC DBS implant. Participants will undergo MRI-compatible testing while bipolar DBS stimulation settings are applied to examine effects on posture, gait, and freezing episodes. The work combines imaging data with clinical and cognitive measures to see how stimulation location and settings relate to levodopa‑resistant axial motor symptoms. Safety and tolerability during MRI with the implanted device will also be monitored.
Who should consider this trial
Good fit: Adults aged 21 or older with Parkinson's disease who have an MR‑compatible Medtronic Percept or Percept RC DBS implant and can undergo MRI and communicate in English are ideal candidates.
Not a fit: People without an MR‑compatible DBS device, those who cannot undergo MRI (including pregnant individuals, those with extreme claustrophobia, or other MRI contraindications), or individuals unable to consent are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could reduce disabling balance and walking problems, including freezing, for people whose gait symptoms do not respond well to medication.
How similar studies have performed: Prior DBS work has reliably improved tremor and appendicular symptoms but has shown mixed or limited success for levodopa‑resistant gait and balance problems, so an imaging‑guided bipolar approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 21 and up * Implanted with MR-compatible DBS device (Medtronic Percept/Percept RC DBS System) for treatment of Parkinson's disease * English speaking Exclusion Criteria: * Unable to consent for themselves * Implanted with a DBS device that is not MR compatible * Pregnant * Extreme claustrophobia * Any contraindications for MRI
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Noam Harel, PhD — University of Minnesota
- Study coordinator: Sarah Bedell
- Email: sbedell@umn.edu
- Phone: 612-625-5396
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.