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
• 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

• Parkinson Disease
• Parkinson's Disease

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

External Links

•   Mayo Clinic Clinical Trials