Chronic Effects of DBS in Parkinson's Disease and Dystonia

Not Applicable

Completed

• Conditions: Parkinson's Disease; Isolated Dystonia
• Interventions: Device: Activa PC+S

• Registration Number: NCT01934296
• Lead Sponsor: University of California, San Francisco

Brief Summary

The purpose of this study is to use an investigational device to record brain activity for 12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The goal of the study is better understanding of brain activity in movement disorders and how they relate to DBS, not to bring new devices to market.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-04
• Study Start: 2013-11
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Results First Submitted: 2022-12-22
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Results First Posted: 2023-04-24
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chronic brain recording	Activa PC+S	This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals	24 months	To report number of PD patients with reliable cortical and subcortical brain signal recorded using Activa PC+S.

Trial Locations

Locations (1)

UCSF Surgical Movement Disorders Center; 🇺🇸 San Francisco, California, United States