Deep Brain Stimulation in Patients With Parkinson's Disease | NCT00586079

Studies
Deep Brain Stimulation in Patients With Parkinson's Disease

NCT00586079

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Mar 18, 2016Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Parkinson's Disease

Interventions

Deep brain stimulation surgery.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Dec 21, 2007

First Posted Date

Jan 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2016

Last Update Posted Date

Mar 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Deep brain stimulation surgery.	Procedure	Deep brain stimulation surgery.	A B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

82 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Virgilio Evidente, M.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Scottsdale	Arizona	85259	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided