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Trial record 1 of 1 for:    NCT01934296
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Chronic Effects of DBS in Parkinson's Disease and Dystonia (Activa PC+S)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2016 by Philip Starr, University of California, San Francisco
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Philip Starr, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01934296
First received: August 29, 2013
Last updated: May 19, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Parkinson's Disease Isolated Dystonia Device: Activa PC+S Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Philip Starr, University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 10
Study Start Date: November 2013
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   22 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria(both groups):

  • Ability to give informed consent for the study
  • Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria

Inclusion criteria (Isolated dystonia):

  • Age 22-75
  • Isolated dystonia that is generalized or segmental, that must affect one or - Stable doses of anti-dystonia medications (such as Artane, Baclofen, or Clonopin) for at least 30 days prior to baseline assessment
  • For patients with craniofacial involvement, prior treatment with botulinum toxin with failure to adequately control dystonia symptoms.

Inclusion criteria (PD):

  • Age 30-75
  • Bilateral disease (Hoehn and Yahr stage 2 or greater)
  • Has been treated with levodopa/carbidopa, and with a dopamine agonist, at the maximal tolerated doses as determined by a movement disorders neurologist
  • Stable doses of antiParkinsonian medications for at least 30 days prior to their baseline assessment
  • Significant disability in the setting of optimal medical management by a movement disorders neurologist. Disability may be due to tremor that is unresponsive to medications, or to motor fluctuations
  • UPDRS-III score off medication between 20 and 60
  • Improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score.

Exclusion Criteria (both groups):

  • Pregnancy or breast feeding
  • MRI showing cortical atrophy out of proportion to age
  • MRI showing focal brain lesions that could indicate a non-idiopathic movement disorder,
  • Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
  • Inability to comply with study follow-up visits
  • Any prior intracranial surgery
  • Mood depression with a Beck depression inventory score of > 17 on baseline screening
  • Significant cognitive impairment (MoCA<25).
  • History of seizures
  • Immunocompromised
  • Has an active infection
  • Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic - Has an implanted electronic device such as a neurostimulator, cardiac pacemaker or medication pump.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934296

Contacts
Contact: Sarah Wang, PhD 415-353-7885 sarah.wang@ucsf.edu
Contact: Kristen Dodenhoff, BA 415-353-8328 kristen.dodenhoff@ucsf.edu

Locations
United States, California
UCSF Surgical Movement Disorders Center Recruiting
San Francisco, California, United States, 94115
Contact: Sarah Wang, PhD    415-353-7885    sarah.wang@ucsf.edu   
Principal Investigator: Philip A. Starr, MD, PhD         
Sponsors and Collaborators
University of California, San Francisco
Medtronic
Investigators
Principal Investigator: Philip Starr, MD University of California, San Francisco
  More Information

Responsible Party: Philip Starr, Professor, Neurological Surgery, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01934296     History of Changes
Other Study ID Numbers: Activa PC+S
Study First Received: August 29, 2013
Last Updated: May 19, 2016

Keywords provided by Philip Starr, University of California, San Francisco:
deep brain stimulation
cortical recording
neuroprosthesis

Additional relevant MeSH terms:
Parkinson Disease
Dystonia
Dystonic Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 26, 2017