Improving Rehabilitation by Magnetic Brain Stimulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00636701
First received: March 7, 2008
Last updated: April 15, 2015
Last verified: April 2015
  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, 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:
  • Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks [ Time Frame: Baseline (day 0) and 2 weeks ] [ Designated as safety issue: No ]
    Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. In 1990, three papers published by Seiji Ogawa and colleagues showed that haemoglobin has different magnetic properties in its oxygenated and deoxygenated forms, both of which could be detected using MRI. This leads to magnetic signal variation which can be detected using an MRI scanner. Given many repetitions of a thought, action or experience, statistical methods can be used to determine the areas of the brain which reliably have more of this difference as a result, and therefore which areas of the brain are active during that thought, action or experience. The percentage BOLD was measures at day 0 and day two weeks. We measured the change in the dependent measure from day 0 to day 2 weeks .


Enrollment: 4
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: Primed rTMS
Receive 10 min. of 6-Hz rTMS Repetitive Transcranial Magnetic Stimulation at 90% RMT (3,600 pulses). Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
Device: Repetitive Transcranial Magnetic Stimulation
We will position a coil over the motor cortex of the head and give a series of stimulations (called magnetic pulses).
Other Name: RTMS
Placebo Comparator: Unprimed rTMS)
Receive 10 min. of sham rTMS Repetitive Transcranial Magnetic Stimulation. Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
Device: Repetitive Transcranial Magnetic Stimulation
We will position a coil over the motor cortex of the head and give a series of stimulations (called magnetic pulses).
Other Name: RTMS

Detailed Description:

This case series assesses the effects of five consecutive days of low‐frequency (1 Hz) repetitive transcranial magnetic stimulation (rTMS) with and without a 6‐Hz primer. Although this paper studies able‐bodied individuals, similar rTMS protocols are used to facilitate motor recovery in patients with hemiplegia following stroke. However, the cortical mechanisms associated with repeated daily doses of rTMS are not completely understood.

  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

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00636701     History of Changes
Other Study ID Numbers: B4657-P
Study First Received: March 7, 2008
Results First Received: November 20, 2014
Last Updated: April 15, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cerebrovascular Accident
rehabilitation

ClinicalTrials.gov processed this record on April 30, 2015