New stimulation patterns for treating Parkinson's disease
Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease - UNMC/Medtronic Collaborative Acute Feasibility Pilot
This study is testing new brain stimulation patterns in people with Parkinson's disease to see if they can improve treatment and reduce side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT04799470 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of novel deep brain stimulation (DBS) patterns in patients with Parkinson's disease who have been implanted with the Medtronic Percept PC device. It is an open-label, non-randomized proof-of-concept study that compares clinical stimulation patterns with research-designed patterns aimed at reducing excessive brain synchrony. The goal is to determine if these tailored stimulation patterns can provide more effective therapy with fewer side effects. A total of 15 subjects will be enrolled to assess the potential benefits of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are patients with idiopathic Parkinson's disease who have been recommended for subthalamic nucleus deep brain stimulation and have been implanted with the Medtronic Percept PC device.
Not a fit: Patients who are not implanted with the Medtronic Percept PC device or those who do not meet the study's inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with Parkinson's disease.
How similar studies have performed: While this approach is innovative, prior foundational research supports the hypothesis that tailored stimulation patterns may improve outcomes, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with idiopathic Parkinson's Disease who were recommended for STN DBS using standard clinical inclusion and exclusion criteria (e.g., presence of coagulopathy, dementia, untreated depression, pre-existing implanted stimulation system, prior intracranial surgery, history of alcohol or drug abuse) * Patients have been previously implanted with bilateral STN DBS and the Medtronic Percept PC implantable neural stimulator. * Patients are optimized for clinical stimulation and medication for at least 3 months post-surgery for the implantation of their DBS system. * Consent to study participation * Presence of a robust beta peak (detectable using the Percept BrainSense Survey feature; ≥ 0.7 µV/rtHz), intra-operatively (assessed via Lead Confirm technology from Alpha Omega) * Good response to stimulation (30% improvement on UPDRS III compared to baseline OFF), at least 3 months post-surgery. Exclusion Criteria: * Not currently implanted with the Medtronic Percept INS * Not willing to participate in the study * Unstable stimulation with need for frequent reprogramming or further adjustment * Significant stimulation-induced side effects * Need for unusual programming parameters such as very high (\> 200 Hz) or low (\< 100) frequencies (due to cycle limitations) * The patient has an implanted cardiac device * The patients Medtronic Percept TM PC indicates elective-replacement-indicated (ERI) at the start of the study
Where this trial is running
Omaha, Nebraska
- Unversity of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Aviva Abosch, MD, PhD — University of Nebraska
- Study coordinator: Dulce Maroni, PhD
- Email: dmaroni@unmc.edu
- Phone: 402-215-3053
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.