Chronic Effects of DBS in Parkinson's Disease and Dystonia (Activa PC+S)
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|ClinicalTrials.gov Identifier: NCT01934296|
Recruitment Status : Unknown
Verified May 2016 by Philip Starr, University of California, San Francisco.
Recruitment status was: Recruiting
First Posted : September 4, 2013
Last Update Posted : May 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Isolated Dystonia||Device: Activa PC+S||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Chronic Effects of Deep Brain Stimulation on Cortical Local Field Potentials in Parkinson's Disease and Dystonia|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||December 2017|
Experimental: chronic brain recording
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.
Device: Activa PC+S
Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation
- Cortical and sub-cortical brain signals using Activa PC+S [ Time Frame: 12 months ]Establish whether it is possible to record a reliable cortical and subcortical brain signal using Activa PC+S.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934296
|Contact: Sarah Wang, PhDemail@example.com|
|Contact: Kristen Dodenhoff, BAfirstname.lastname@example.org|
|United States, California|
|UCSF Surgical Movement Disorders Center||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Sarah Wang, PhD 415-353-7885 email@example.com|
|Principal Investigator: Philip A. Starr, MD, PhD|
|Principal Investigator:||Philip Starr, MD||University of California, San Francisco|