Status:
RECRUITING
Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease
Lead Sponsor:
University of Nebraska
Conditions:
Parkinson's Disease
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
This is an open-label, non-randomized, proof-of-concept comparison of clinical vs. research stimulation patterns in patients with Parkinson's disease (PD) being treated with Deep Brain Stimulation (DB...
Detailed Description
Parkinson's disease (PD) is a neurodegenerative disorder characterized by both motor and non-motor symptoms. Motor symptoms of PD include the clinical triad of tremor, rigidity, and bradykinesia, and ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04799470
Start Date
May 10 2021
End Date
April 1 2026
Last Update
August 15 2025
Active Locations (1)
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1
Unversity of Nebraska Medical Center
Omaha, Nebraska, United States, 68118