Comparing neurostimulator settings for Parkinson's disease treatment
Aim 3 Particle Swarm Optimization Postural Instability Gait Disorder
This study is testing two different settings for a brain device to see which one helps people with Parkinson's disease feel better and improve their movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05934747 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of two different neurostimulator settings on Parkinson's disease symptoms in patients receiving Deep Brain Stimulation (DBS) therapy. The settings are designed to activate distinct neuroanatomical pathways: one from the Globus Pallidus to the Pedunculopontine Nucleus, and the other from the Pedunculopontine Nucleus back to the Globus Pallidus. Participants will be monitored over two weeks to assess clinically relevant outcomes such as activities of daily living and quality of life. The goal is to determine which neurostimulator setting is more effective for addressing postural instability and gait disorders in Parkinson's patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 diagnosed with Parkinson's disease who have undergone bilateral DBS and meet cognitive assessment criteria.
Not a fit: Patients with significant gait impairment due to conditions other than Parkinson's disease or those unable to walk in the off-medication, off-stimulation condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for managing Parkinson's disease symptoms, particularly gait and postural instability.
How similar studies have performed: Similar studies have shown promise in optimizing neurostimulator settings for Parkinson's disease, but this specific approach is novel in its extended observational period.
Eligibility criteria
Show full inclusion / exclusion criteria
* Diagnosis of Parkinson's Disease * Bilateral DBS in STN or GP * At least 3 months after lead implantation * Montreal Cognitive Assessment (MoCA): MoCA=23+ OR: If MoCA score is 23 or less, UBACC will be performed to ensure capacity to consent. If UBACC results are unclear, the MacCAT-CR will be performed. Failed or unclear MacCAT-CR results will exclude the study candidate. * Between 18-85 years of age * Has undergone pre-operative 7T MRI (as part of protocol #1210M22183 or standard-of-care) and post-operative CT imaging (standard of care). 8.2 Exclusion Criteria: * Inability to walk in the off-med, off-stimulation condition (even with safety harness) * Gait impaired significantly by a condition other than PD * Breaks or shorts in active contacts * IPG battery nearing end of life (in patients with primary-cell IPGs) * Females who are nursing or pregnant
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- 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.