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NCT02384421 · ClinicalTrials.gov registry record · NA
Adaptive Closed Loop Neuromodulation and Neural Signatures of Parkinson's Disease
A NA study, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT02384421: Completed NA study, sponsored by Stanford University.
NCT02384421 is a NA study that has completed, run by Stanford University. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02384421, a NA study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study Summary
Continuous deep brain stimulation (cDBS) is an established therapy for the major motor signs in Parkinson's disease. Currently, cDBS is limited to "open-loop" stimulation, without real-time adjustment to the patient's state of activity, fluctuations and types of motor symptoms, medication dosages, or neural markers of the disease. The purpose of this study is to determine if an adaptive DBS system, responding to patient specific, clinically relevant neural or kinematic feedback, is efficacious on the motor Unified Parkinson's Disease Rating Scale (UPDRS III) and specific phenotypic measures in Parkinson's Disease compared to OFF therapy (i.e., OFF DBS and withdrawn from medication) and more efficient than cDBS. Not every recruited participant completed every part of the protocol.
Primary Outcome
Beta Band Power will be recorded continuously during intervention (30 minutes). The PC+S streams off power of the local field potential signal measured from the subthalamic nucleus in a frequency band of interest within the beta band (13-30 Hz). The amplitude of the signal, beta power, was streamed from each subthalamic nucleus (STN) during the calibration period of the experiment when DBS was off (i.e., OFF therapy), when continuous DBS was set at the lower and upper stimulation voltage that we
Interventions
- DEVICE Adaptive DBS (Activa PC+S Neurostimulator)
- DEVICE Continuous DBS (Activa PC+S Neurostimulator)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2015-01 |
| Est. Completion | 2021-08-16 |
| Phase | NA |
What the finished NCT02384421 record still lists
NCT02384421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Adaptive DBS (Activa PC+S Neurostimulator) is the first listed.
NCT02384421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02384421 about?
NCT02384421 is a clinical study titled "Adaptive Closed Loop Neuromodulation and Neural Signatures of Parkinson's Disease". Continuous deep brain stimulation (cDBS) is an established therapy for the major motor signs in Parkinson's disease. Currently, cDBS is limited to "open-loop" stimulation, without real-time adjustment to the patient's state of activity, fluctuations and types of motor symptoms, medication dosages, o...
What is the current status of trial NCT02384421?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2015-01. Estimated completion is 2021-08-16.
What interventions are being tested in trial NCT02384421?
The interventions under investigation include: Adaptive DBS (Activa PC+S Neurostimulator) (DEVICE), Continuous DBS (Activa PC+S Neurostimulator) (DEVICE).
Who is sponsoring clinical trial NCT02384421?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02384421's enrollment target sits among peer trials
22 1756th of 2000 higher than 239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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