CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Adaptive DBS (Activa PC+S Neurostimulator) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02384421
NCT02384421N/ACompleted

Adaptive Closed Loop Neuromodulation and Neural Signatures of Parkinson's Disease

Stanford University·interventional·Posted Mar 10, 2015·Updated Feb 1, 2022

In Brief

A clinical study evaluating Adaptive DBS (Activa PC+S Neurostimulator) and Continuous DBS (Activa PC+S Neurostimulator) for Parkinson's Disease. Completed, enrolled 22 participants across 1 site.

Detailed 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Scale (UPDRS III) and specific phenotypic measures in Parkinson's Disease compared to OFF therapy (i.e., OFF DBS and withdrawn from medication) and more efficient than cDBS.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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 10, 2015
Enrollment StartJan 1, 2015
Primary CompletionSep 23, 2019
Study CompletionAug 16, 2021
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 11.3 years ago

Interventions

Adaptive DBS (Activa PC+S Neurostimulator)device

Continuous DBS (Activa PC+S Neurostimulator)device