Improving Rehabilitation by Magnetic Brain Stimulation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

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)

Group Type PLACEBO_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

Interventions

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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).

Intervention Type DEVICE

Other Intervention Names

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RTMS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes