This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Study of Subthalamic Brain Stimulation in Parkinson Disease (PD)

This study has been completed.
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: April 10, 2017
Last verified: April 2017
  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
Parkinson Disease Device: Implantable pulse generator (deep brain stimulator)

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:


Further study details as provided by Harrison Walker, MD, 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. ]

Enrollment: 175
Study Start Date: February 2010
Study Completion Date: November 2014
Primary Completion Date: November 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT01113684

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
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 ( US NIH Grant/Contract Award Number )
Study First Received: April 26, 2010
Last Updated: April 10, 2017

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 June 27, 2017