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Clinical Trials/NCT01113684
NCT01113684
Completed
N/A

Clinical and Neurophysiological Study of Subthalamic Brain Stimulation in PD

University of Alabama at Birmingham1 site in 1 country175 target enrollmentFebruary 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University of Alabama at Birmingham
Enrollment
175
Locations
1
Primary Endpoint
This study measures neurophysiological responses to subthalamic deep brain stimulation in the central and peripheral nervous system in patients with Parkinson disease.
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
November 2014
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Harrison Walker, MD

Assistant Professor

University of Alabama at Birmingham

Eligibility 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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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