Improving Rehabilitation by Magnetic Brain Stimulation

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636701
• Other study ID #: B4657-P
• Status: Completed
• Phase: Phase 1
• First received: March 7, 2008
• Last updated: April 15, 2015
• Start date: September 2007
• Est. completion date: May 2009

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

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).

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Glielmi CB, Butler AJ, Niyazov DM, Darling WG, Epstein CM, Alberts JL, Hu XP. Assessing low-frequency repetitive transcranial magnetic stimulation with functional magnetic resonance imaging: a case series. Physiother Res Int. 2014 Jun;19(2):117-25. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks	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 .	Baseline (day 0) and 2 weeks	No