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Deep Brain Stimulation in Patients With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00586079
Recruitment Status : Completed
First Posted : January 4, 2008
Last Update Posted : March 18, 2016
Sponsor:
Information provided by (Responsible Party):
Virgilio Evidente, Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment
Parkinson's Disease Procedure: 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2007
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. The primary measures are six EEG bereitschaftspotential areas and amplitudes. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Unified Parkinson's disease rating scale score. [ Time Frame: At time of EEG measurement. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 82 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Virgilio Evidente, Professor of Neurology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586079     History of Changes
Other Study ID Numbers: 06-003248
First Posted: January 4, 2008    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: April 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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