NCT00586079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 18, 2016

Status Verified

April 1, 2015

Enrollment Period

3.9 years

First QC Date

December 21, 2007

Last Update Submit

March 17, 2016

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • The primary measures are six EEG bereitschaftspotential areas and amplitudes.

    12 months

Secondary Outcomes (1)

  • Unified Parkinson's disease rating scale score.

    At time of EEG measurement.

Study Arms (2)

A

EXPERIMENTAL

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

Procedure: Deep brain stimulation surgery.

B

EXPERIMENTAL

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

Procedure: Deep brain stimulation surgery.

Interventions

Deep brain stimulation surgery.PROCEDURE

Deep brain stimulation surgery.

AB

Eligibility Criteria

Age40 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients unable to do repetitive dorsiflexion of the wrist due to orthopedic problems.
  • Pregnant women.
  • Prisoners or institutionalized individuals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Virgilio Evidente, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

July 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 18, 2016

Record last verified: 2015-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)