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
  Purpose

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


Condition Intervention Phase
Stroke
Device: Repetitive Transcranial Magnetic Stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Rehabilitation by Magnetic Brain Stimulation: Improving Motor Recovery After Stroke

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • WMFT [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2007
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Receive rTMS
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
Placebo Comparator: 2
Receive sham rTMS
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636701

Locations
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Investigators
Principal Investigator: Andrew Butler, PhD MS BA Atlanta VA Medical and Rehab Center, Decatur
  More Information

No publications provided

Responsible Party: Butler, Andrew - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00636701     History of Changes
Other Study ID Numbers: B4657P
Study First Received: March 7, 2008
Last Updated: May 7, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cerebrovascular Accident
rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014