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Deep Brain Stimulation in Patients With Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virgilio Evidente, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586079
First received: December 21, 2007
Last updated: October 1, 2011
Last verified: October 2011
History of Changes
  Purpose

The purpose of this study is to determine the effect of deep brain stimulation surgery on movement-related cortical potentials in patients with Parkinson's disease.


Condition Intervention
Parkinson's Disease
 Procedure: Deep brain stimulation surgery.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect of Deep Brain Stimulation on Movement-Related Cortical Potentials in Patients With Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • The primary measures are six EEG bereitschaftspotential areas and amplitudes. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Unified Parkinson's disease rating scale score. [ Time Frame: At time of EEG measurement. ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Ten patients who have had deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona.
 Procedure: Deep brain stimulation surgery.
Deep brain stimulation surgery.
Experimental: B
Ten patients who are scheduled to have deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona.
 Procedure: Deep brain stimulation surgery.
Deep brain stimulation surgery.

Detailed Description:

Patients who have had deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona will have electroencephalographic (EEG) measurements with the stimulator on followed by EEG measurements with the stimulator off. Patients who are scheduled to have deep brain stimulation surgery for Parkinson's disease will have EEG measurements before and after surgery.

  Eligibility

Ages Eligible for Study:   40 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have had deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona, or who are scheduled to have deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona.

Exclusion Criteria:

  • Patients unable to do repetitive dorsiflexion of the wrist due to orthopedic problems.
  • Pregnant women.
  • Prisoners or institutionalized individuals.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586079

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Virgilio Evidente, M.D. Mayo Clinic
  More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Virgilio Evidente, Professor of Neurology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586079     History of Changes
Other Study ID Numbers: 06-003248
Study First Received: December 21, 2007
Last Updated: October 1, 2011
Health Authority: United States: Food and Drug Administration

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 17, 2013