Deep Brain Stimulation in Patients With Parkinson's Disease

March 17, 2016 updated by: Virgilio Evidente, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary measures are six EEG bereitschaftspotential areas and amplitudes.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Unified Parkinson's disease rating scale score.
Time Frame: At time of EEG measurement.
At time of EEG measurement.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Virgilio Evidente, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 4, 2008

Study Record Updates

Last Update Posted (Estimate)

March 18, 2016

Last Update Submitted That Met QC Criteria

March 17, 2016

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-003248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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