Improving Rehabilitation by Magnetic Brain Stimulation

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00636701
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Repetitive Transcranial Magnetic Stimulation	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Rehabilitation by Magnetic Brain Stimulation: Improving Motor Recovery After Stroke
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: RTMS

Outcome Measures

Primary Outcome Measures

1. Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks [Baseline (day 0) and 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 .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Atlanta VA Medical and Rehab Center, Decatur	Decatur	Georgia	United States	30033

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Andrew Butler, PhD MS BA, Atlanta VA Medical and Rehab Center, Decatur

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00636701
• Other Study ID Numbers: B4657-P
• First Posted: Mar 14, 2008
• Last Update Posted: May 1, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by US Department of Veterans Affairs: Cerebrovascular Accident; rehabilitation
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	Receive rTMS (Repetitive Transcranial Magnetic Stimulation) 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	Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation) 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
Period Title: Overall Study
STARTED	2	2
COMPLETED	2	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm 1	Arm 2	Total
Arm/Group Description	Receive rTMS (Repetitive Transcranial Magnetic Stimulation) 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	Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation) 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	Total of all reporting groups
Overall Participants	2	2	4
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	2 100%	4 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	1 50%	1 50%	2 50%
Male	1 50%	1 50%	2 50%
Region of Enrollment (participants) [Number]
United States	2 100%	2 100%	4 100%

Outcome Measures

1. Primary Outcome

Title	Percentage BOLD (Blood-oxygen-level Dependent Contrast Imaging) Signal From Baseline at 2 Weeks
Description	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 .
Time Frame	Baseline (day 0) and 2 weeks

Outcome Measure Data

Analysis Population Description

Four right-handed healthy volunteers (two men, aged 20-50 years) participated in a double-blind study of primed and unprimed rTMS.

Arm/Group Title	Number of Participants Who Received Primed rTMS	Number of Participants Who Received Unprimed rTMS
Arm/Group Description	Number of participants who received 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)	Number of participants who received 10 min. of sham rTMS Repetitive Transcranial Magnetic Stimulation. Followed by 30 min. of 1-Hz rTMS at 95% RMT (1,880 pulses)
Measure Participants	2	2
Mean (Standard Deviation) [percentage change of BOLD]	3 (.5)	2 (.25)

Adverse Events

Arm/Group Title	Arm 1		Arm 2
Arm/Group Description	Receive rTMS (Repetitive Transcranial Magnetic Stimulation) 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		Receive sham rTMS (Repetitive Transcranial Magnetic Stimulation) 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
All Cause Mortality
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.