Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis

September 10, 2019 updated by: George Mason University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar National Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in movement time
Time Frame: Baseline and 1 Day
Percentage change in time it takes to move the arm a standardized distance
Baseline and 1 Day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Mason University

Collaborators

MedStar National Rehabilitation Network

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2017

Primary Completion (Actual)

August 15, 2019

Study Completion (Actual)

August 28, 2019

Study Registration Dates

First Submitted

February 24, 2017

First Submitted That Met QC Criteria

February 24, 2017

First Posted (Actual)

March 1, 2017

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21HD090516-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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