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Deep Brain Stimulation in Patients With Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep brain stimulation surgery.
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease

Eligibility Criteria

40 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

Ten patients who have had deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona.

Ten patients who are scheduled to have deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona.

Outcomes

Primary Outcome Measures

The primary measures are six EEG bereitschaftspotential areas and amplitudes.

Secondary Outcome Measures

Unified Parkinson's disease rating scale score.

Full Information

First Posted
December 21, 2007
Last Updated
March 17, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00586079
Brief Title
Deep Brain Stimulation in Patients With Parkinson's Disease
Official Title
The Effect of Deep Brain Stimulation on Movement-Related Cortical Potentials in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Ten patients who have had deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona.
Arm Title
B
Arm Type
Experimental
Arm Description
Ten patients who are scheduled to have deep brain stimulation surgery for Parkinson's disease at Mayo Clinic Arizona.
Intervention Type
Procedure
Intervention Name(s)
Deep brain stimulation surgery.
Intervention Description
Deep brain stimulation surgery.
Primary Outcome Measure Information:
Title
The primary measures are six EEG bereitschaftspotential areas and amplitudes.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Unified Parkinson's disease rating scale score.
Time Frame
At time of EEG measurement.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virgilio Evidente, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Deep Brain Stimulation in Patients With Parkinson's Disease

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