Optimizing Deep Brain Stimulation for Parkinson's Disease Gait Issues
Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder
This study is testing if adjusting brain stimulation settings can help people with Parkinson's disease walk better and improve their balance.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05893186 on ClinicalTrials.gov |
What this trial studies
This study involves sixty patients with Parkinson's disease who are receiving bilateral deep brain stimulation (DBS) to improve their gait and balance. Using advanced imaging techniques, including 7 Tesla MRI and postoperative CT scans, researchers will create patient-specific models to optimize DBS settings. The goal is to selectively activate specific neural pathways associated with gait and balance, comparing different stimulation settings to determine the most effective approach. Participants will undergo testing to measure improvements in gait, balance, bradykinesia, and rigidity.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Parkinson's disease who have undergone bilateral deep brain stimulation and meet specific imaging and timing criteria.
Not a fit: Patients with significant neurological or musculoskeletal disorders affecting movement, dementia, or those who have had prior neurosurgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with Parkinson's disease, improving their mobility and quality of life.
How similar studies have performed: While this approach is innovative, similar studies using advanced imaging and personalized stimulation settings have shown promise in improving outcomes for patients with movement disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of PD * Bilateral DBS * Directional DBS electrode system * MRI, at least 7 Tesla, with diffusion tensor imaging, prior to DBS surgery * Head CT, at least 1mm cuts, following DBS surgery * At least 3 months since initial activation of the neurostimulator Exclusion Criteria: * Neurological or musculoskeletal disorder that significantly affects gait, balance, or limb movements * Dementia * Prior stereotactic neurosurgery other than DBS for movement disorder * Pregnancy
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Scott Cooper, MD, PhD — University of Minnesota
- Study coordinator: Johanna Caskey, BA
- Email: caske039@umn.edu
- Phone: 763-353-9470
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.