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Study of Subthalamic Brain Stimulation in Parkinson Disease (PD)

This study is currently recruiting participants.
Verified October 2012 by University of Alabama at Birmingham
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Harrison Walker, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01113684
First received: April 26, 2010
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
  Purpose

Deep brain stimulation (DBS) improves debilitating symptoms of movement disorders when conventional medical therapies and novel surgical therapies fail. Despite the remarkable efficacy of DBS, its therapeutic mechanism remains unclear. There is controversy regarding whether the therapeutic effects of DBS are associated with inhibition or excitation of target neurons, the introduction of new activity into the network, or a combination of these mechanisms. Additionally, it is unclear why stimulus frequency plays an important role in the clinical response to therapy. The fundamental hypothesis of this proposal is that unilateral subthalamic nucleus (STN) DBS in PD alters neuronal activity in the bilateral basal ganglia-thalamic-cortical motor system in a manner that is dependent on stimulation frequency.


Condition Intervention Phase
Parkinson Disease
 Device: Implantable pulse generator (deep brain stimulator)
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Neurophysiological Study of Subthalamic Brain Stimulation in PD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • This study measures neurophysiological responses to subthalamic deep brain stimulation in the central and peripheral nervous system in patients with Parkinson disease. [ Time Frame: Population data will be analyzed for the primary endpoint in 12 months and reported in approximately 18 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Implantable pulse generator (deep brain stimulator)
    This study evaluates the effects of subthalamic deep brain stimulation on central and peripheral nervous system activity in patients who have already had brain stimulators placed as a matter of routine clinical care.
    Other Names:
    • Soletra Implantable Pulse Generator (Medtronic, Inc.)
    • Kinetra Implantable Pulse Generator (Medtronic, Inc.)
    • Activa PC Implantable Pulse Generator (Medtronic, Inc.)
    • Activa RC Implantable Pulse Generator (Medtronic, Inc.)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Parkinson's disease who have undergone subthalamic deep brain stimulation

Criteria

Inclusion Criteria:

  • Patients with Parkinson disease who have undergone subthalamic deep brain stimulation

Exclusion Criteria:

  • Patients who are unable to follow verbal instructions
  • Patients who are unable to tolerate being off their Parkinson's medications for 12 hours
  • Patients who are medically unstable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113684

Contacts
Contact: Chris L Gonzalez, MS 205-975-3732 clg17@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Harrison C Walker, MD            
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Harrison C Walker, MD University of Alabama at Birmingham, Department of Neurology
  More Information

Publications:

Responsible Party: Harrison Walker, MD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01113684     History of Changes
Other Study ID Numbers: F091215017, 1K23NS067053-01
Study First Received: April 26, 2010
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 23, 2013