Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis

Stroke Clinical Trial

Official title:

Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067818
• Other study ID #: 1R21HD090516-01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cerebral Vascular Accident
• Hemiparesis
• Paralysis
• Paresis
• Stroke
• Stroke, Ischemic

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