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NCT04799470 · ClinicalTrials.gov registry record · NA
Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease
A NA study of Parkinson's Disease, sponsored by University of Nebraska.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04799470 is a NA study of Parkinson's Disease that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 10 participants, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04799470, a NA study of Parkinson's Disease, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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 (DBS) through the Medtronic Percept PC DBS device. The investigators hypothesize that stimulation patterns designed to better target excessive synchrony in a patient-tailored manner may result in more efficient and effective therapy with fewer side effects. Medtronic 3rd-generation sensing implantable neural stimulator, Percept PC, is FDA-approved for treating PD. The Percept PC device features BrainSense, the first and only available sensing technology for deep brain stimulation. BrainSense technology allows the device to capture and record brain signals (local field potentials, or LFP) using the brain-implanted DBS lead, while simultaneously delivering therapeutic stimulation. Investigators plan to enroll and complete investigations in 15 study subjects total, who have been previously implanted with the Medtronic Percept PC for the treatment of PD, and who are optimized for clinical stimulation and anti-Parkinsons medication. Investigations will be performed in UNMC Movement Disorders Clinic, UNMC Neurosurgery Lab, and UNO Biomechanics Research Building, Gait Lab. Subjects will receive research stimulation patterns and the effect on PD motor symptoms will be assessed via Unified Parkinsons Disease Rating Scale (UPDRS)-part III and gait measures. Videotaping of patient UPDRS-III testing and gait will be obtained.
Conditions Studied
Interventions
- DEVICE Novel DBS stimulation patterns
Study Locations (1)
Nebraska
- Unversity of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-05-10 |
| Est. Completion | 2026-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04799470
The ClinicalTrials.gov registry entry for NCT04799470 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (98% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention - of which Novel DBS stimulation patterns is the first listed.
NCT04799470 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.
Frequently Asked Questions
What is clinical trial NCT04799470 about?
NCT04799470 is a clinical study titled "Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease". 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 (DBS) through the Medtronic Percept PC DBS device. The investigators hypothesize that stimulation patte...
What is the current status of trial NCT04799470?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2021-05-10. Estimated completion is 2026-04.
What conditions does trial NCT04799470 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT04799470?
The interventions under investigation include: Novel DBS stimulation patterns (DEVICE).
Who is sponsoring clinical trial NCT04799470?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04799470 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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