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NCT00586079 Clinical Trial

Deep Brain Stimulation in Patients With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:
The Effect of Deep Brain Stimulation on Movement-Related Cortical Potentials in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00586079
Other study ID # 06-003248
Secondary ID
Status Completed
Phase N/A
First received December 21, 2007
Last updated March 17, 2016
Start date July 2007
Est. completion date June 2011

Study information
Verified date April 2015
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 82 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Procedure:
• Deep brain stimulation surgery.
Deep brain stimulation surgery.

Locations
Country Name City State
United States Mayo Clinic Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary measures are six EEG bereitschaftspotential areas and amplitudes. 12 months No
Secondary Unified Parkinson's disease rating scale score. At time of EEG measurement. No
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