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Clinical Trials/NCT03067818
NCT03067818CompletedNot Applicable

Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis

George Mason University1 site in 1 country10 target enrollmentStarted: June 20, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Change in movement time

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Unaffected Hemisphere

Experimental

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

Intervention: Unaffected Transcranial Magnetic Stimulation (Procedure)

Affected Hemisphere

Experimental

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

Intervention: Affected Transcranial Magnetic Stimulation (Procedure)

Control Site

Active Comparator

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

Intervention: Control Transcranial Magnetic Stimulation (Procedure)

Outcomes

Primary Outcomes

Change in movement time

Time Frame: Baseline and 1 Day

Percentage change in time it takes to move the arm a standardized distance

Secondary Outcomes

  • Change in maximum reaching distance(Baseline and 1 Day)
  • Change in hand path kinematics(Baseline and 1 Day)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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