Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis

NCT ID: NCT03067818

Last Updated: 2019-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2019-08-28

Brief Summary

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This study examines the effect of non-invasive brain stimulation targeting different brain areas on movement of the affected arm post-stroke. Participants will receive stimulation to each of 3 different brain areas combined with a session of arm exercise.

Detailed Description

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Small improvements in affected arm movement can be made with intensive physical practice. These improvements could potentially be enhanced by combining non-invasive brain stimulation with practice.

To develop such an intervention, it is necessary to understand which brain areas should be stimulated in which types of patients. It is probably more beneficial to target one side of the brain vs. the other, for example, depending on the characteristics of the stroke.

This study will examine the effect of stimulating one side of the brain vs. the other on the amount of improvement that occurs from physically practicing functional arm movements.

Conditions

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Stroke Hemiparesis Cerebral Vascular Accident Stroke, Ischemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant will receive stimulation targeting each brain area. The order in which the stimulation sites are targeted for each participant is randomized and there is a washout period of several weeks between each treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The individual that conducts the tests of arm movement will be unaware of which brain area was stimulated.

Study Groups

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Unaffected Hemisphere

Application of "Unaffected Transcranial Magnetic Stimulation" to unaffected hemisphere site prior to physical practice

Group Type EXPERIMENTAL

Unaffected Transcranial Magnetic Stimulation

Intervention Type PROCEDURE

Non-invasive brain stimulation to unaffected hemisphere site prior to practice

Affected Hemisphere

Application of "Affected Transcranial Magnetic Stimulation" to affected hemisphere site prior to physical practice

Group Type EXPERIMENTAL

Affected Transcranial Magnetic Stimulation

Intervention Type PROCEDURE

Non-invasive brain stimulation to affected hemisphere site prior to practice

Control Site

Application of "Control Transcranial Magnetic Stimulation" to control site prior to practice

Group Type ACTIVE_COMPARATOR

Control Transcranial Magnetic Stimulation

Intervention Type PROCEDURE

Non-invasive brain stimulation to control site prior to practice

Interventions

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Unaffected Transcranial Magnetic Stimulation

Non-invasive brain stimulation to unaffected hemisphere site prior to practice

Intervention Type PROCEDURE

Affected Transcranial Magnetic Stimulation

Non-invasive brain stimulation to affected hemisphere site prior to practice

Intervention Type PROCEDURE

Control Transcranial Magnetic Stimulation

Non-invasive brain stimulation to control site prior to practice

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* More than 6 months post-stroke
* Loss of voluntary finger movement in the affected hand
* Some voluntary movement of affected shoulder and/or elbow

Exclusion Criteria

* Brainstem or cerebellar stroke
* Severe cognitive or language deficits
* Epilepsy or other seizure disorder
* Central nervous system disease or disorder other than stroke
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedStar National Rehabilitation Network

OTHER

Sponsor Role collaborator

George Mason University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Harris-Love, PhD

Role: PRINCIPAL_INVESTIGATOR

George Mason University

Locations

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MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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1R21HD090516-01

Identifier Type: NIH

Identifier Source: org_study_id

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