Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis

• Sponsor: George Mason University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03067818
• Collaborator: MedStar National Rehabilitation Network (Other)
• Enrollment: 10
• Location: 1
• Arms: 3
• Actual Duration (Months): 26.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Hemiparesis; Cerebral Vascular Accident; Stroke, Ischemic	Procedure: Unaffected Transcranial Magnetic Stimulation; Procedure: Affected Transcranial Magnetic Stimulation; Procedure: Control Transcranial Magnetic Stimulation	N/A

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
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: 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.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.
• Masking: Single (Outcomes Assessor)
• Masking Description: The individual that conducts the tests of arm movement will be unaware of which brain area was stimulated.
• Primary Purpose: Treatment
• Official Title: Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis
• Actual Study Start Date: Jun 20, 2017
• Actual Primary Completion Date: Aug 15, 2019
• Actual Study Completion Date: Aug 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Unaffected Hemisphere Application of "Unaffected Transcranial Magnetic Stimulation" to unaffected hemisphere site prior to physical practice	Procedure: Unaffected Transcranial Magnetic Stimulation; Non-invasive brain stimulation to unaffected hemisphere site prior to practice
Experimental: Affected Hemisphere Application of "Affected Transcranial Magnetic Stimulation" to affected hemisphere site prior to physical practice	Procedure: Affected Transcranial Magnetic Stimulation; Non-invasive brain stimulation to affected hemisphere site prior to practice
Active Comparator: Control Site Application of "Control Transcranial Magnetic Stimulation" to control site prior to practice	Procedure: Control Transcranial Magnetic Stimulation; Non-invasive brain stimulation to control site prior to practice

Outcome Measures

Primary Outcome Measures

1. Change in movement time [Baseline and 1 Day]

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

Secondary Outcome Measures

1. Change in maximum reaching distance [Baseline and 1 Day]

   Percentage change in maximum distance participant is able to reach

2. Change in hand path kinematics [Baseline and 1 Day]

   Percentage change in temporal and spatial movement of the hand during reaching

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedStar National Rehabilitation Hospital	Washington	District of Columbia	United States	20010

Sponsors and Collaborators

• George Mason University
• MedStar National Rehabilitation Network

Investigators

• Principal Investigator: Michelle Harris-Love, PhD, George Mason University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: George Mason University
• ClinicalTrials.gov Identifier: NCT03067818
• Other Study ID Numbers: 1R21HD090516-01
• First Posted: Mar 1, 2017
• Last Update Posted: Sep 11, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by George Mason University: arm; rehabilitation; non-invasive brain stimulation; transcranial magnetic stimulation; upper extremity
• Additional relevant MeSH terms: Stroke; Paralysis; Paresis; Ischemic Stroke

Study Results

No Results Posted as of Sep 11, 2019