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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03067818
Other study ID # 1R21HD090516-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 20, 2017
Est. completion date August 28, 2019

Study information

Verified date September 2019
Source George Mason University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date August 28, 2019
Est. primary completion date August 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Intervention

Procedure:
Unaffected Transcranial Magnetic Stimulation
Non-invasive brain stimulation to unaffected hemisphere site prior to practice
Affected Transcranial Magnetic Stimulation
Non-invasive brain stimulation to affected hemisphere site prior to practice
Control Transcranial Magnetic Stimulation
Non-invasive brain stimulation to control site prior to practice

Locations

Country Name City State
United States MedStar National Rehabilitation Hospital Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
George Mason University MedStar National Rehabilitation Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in movement time Percentage change in time it takes to move the arm a standardized distance Baseline and 1 Day
Secondary Change in maximum reaching distance Percentage change in maximum distance participant is able to reach Baseline and 1 Day
Secondary Change in hand path kinematics Percentage change in temporal and spatial movement of the hand during reaching Baseline and 1 Day
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