Improving Rehabilitation by Magnetic Brain Stimulation

This study has been completed.

Sponsor:

Information provided by:

Department of Veterans Affairs

ClinicalTrials.gov Identifier:

NCT00636701

First received: March 7, 2008

Last updated: May 7, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 7, 2008

Last Updated Date

May 7, 2009

Start Date ^ICMJE

September 2007

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

WMFT [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00636701 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Improving Rehabilitation by Magnetic Brain Stimulation

Official Title ^ICMJE

Improving Rehabilitation by Magnetic Brain Stimulation: Improving Motor Recovery After Stroke

Brief Summary

We hope to understand the properties of the motor cortex in the brain of people with stroke using non-invasive magnetic stimulation.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Stroke

Intervention ^ICMJE

Device: Repetitive Transcranial Magnetic Stimulation

We will position a coil over the motor cortex of your head and give a series of stimulations (called magnetic pulses) for 2 minutes

Study Arm (s)

Experimental: 1
Receive rTMS

Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Placebo Comparator: 2
Receive sham rTMS

Intervention: Device: Repetitive Transcranial Magnetic Stimulation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

3-24 months post stroke
upper limb paresis
CES-D below 16,

Exclusion Criteria:

history of seizure
metal in head
score of less than 24 on the Folstein Mini-Mental Status Exam
clinical judgement of excessive frailty or lack of stamina (e.g. cannot attend to instructions, stay awake, engage in functional activities)
serious uncontrolled medical condition
excessive pain in any joint of the more affected extremity that could limit ability to cooperate with the intervention as judged by the examining clinician

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00636701

Other Study ID Numbers ^ICMJE

B4657P

Has Data Monitoring Committee

Responsible Party

Butler, Andrew - Principal Investigator, Department of Veterans Affairs

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Andrew Butler, PhD MS BA

Atlanta VA Medical and Rehab Center, Decatur

Information Provided By

Department of Veterans Affairs

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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