Study of Subthalamic Brain Stimulation in Parkinson Disease (PD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Alabama at Birmingham
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01113684
First received: April 26, 2010
Last updated: July 24, 2014
Last verified: July 2014

April 26, 2010
July 24, 2014
April 2010
June 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01113684 on ClinicalTrials.gov Archive Site
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Study of Subthalamic Brain Stimulation in Parkinson Disease (PD)
Clinical and Neurophysiological Study of Subthalamic Brain Stimulation in PD

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Parkinson Disease
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.)
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Walker HC, Watts RL, Guthrie S, Wang D, Guthrie BL. Bilateral effects of unilateral subthalamic deep brain stimulation on Parkinson's disease at 1 year. Neurosurgery. 2009 Aug;65(2):302-9; discussion 309-10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Chris L Gonzalez, MS 205-975-3732 clg17@uab.edu
United States
 
NCT01113684
F091215017, 1K23NS067053-01
Yes
University of Alabama at Birmingham
University of Alabama at Birmingham
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Harrison C Walker, MD University of Alabama at Birmingham, Department of Neurology
University of Alabama at Birmingham
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP