Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis

• ClinicalTrials.gov Identifier: NCT03067818
• Recruitment Status: Completed
• First Posted: March 1, 2017
• Last Update Posted: September 11, 2019
• Sponsor: George Mason University
• Collaborator: MedStar National Rehabilitation Network
• Information provided by (Responsible Party): George Mason University

Tracking Information

• First Submitted Date: February 24, 2017
• First Posted Date: March 1, 2017
• Last Update Posted Date: September 11, 2019
• Actual Study Start Date: June 20, 2017
• Actual Primary Completion Date: August 15, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 24, 2017)

Change in movement time [ Time Frame: Baseline and 1 Day ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 24, 2017)

• Change in maximum reaching distance [ Time Frame: Baseline and 1 Day ]
  Percentage change in maximum distance participant is able to reach
• Change in hand path kinematics [ Time Frame: Baseline and 1 Day ]
  Percentage change in temporal and spatial movement of the hand during reaching

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis
• Official Title: Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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.

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

Condition

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

Intervention

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

Study Arms

• Experimental: Unaffected Hemisphere
  Application of "Unaffected Transcranial Magnetic Stimulation" to unaffected hemisphere site prior to physical practice
  Intervention: Procedure: Unaffected Transcranial Magnetic Stimulation
• Experimental: Affected Hemisphere
  Application of "Affected Transcranial Magnetic Stimulation" to affected hemisphere site prior to physical practice
  Intervention: Procedure: Affected Transcranial Magnetic Stimulation
• Active Comparator: Control Site
  Application of "Control Transcranial Magnetic Stimulation" to control site prior to practice
  Intervention: Procedure: Control Transcranial Magnetic Stimulation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 10, 2019): 10
• Original Estimated Enrollment (submitted: February 24, 2017): 26
• Actual Study Completion Date: August 28, 2019
• Actual Primary Completion Date: August 15, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03067818
• Other Study ID Numbers: 1R21HD090516-01( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: George Mason University
• Original Responsible Party: Same as current
• Current Study Sponsor: George Mason University
• Original Study Sponsor: Same as current
• Collaborators: MedStar National Rehabilitation Network

Investigators

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

• PRS Account: George Mason University
• Verification Date: September 2019