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Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis

Primary Purpose

Stroke, Hemiparesis, Cerebral Vascular Accident

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unaffected Transcranial Magnetic Stimulation
Affected Transcranial Magnetic Stimulation
Control Transcranial Magnetic Stimulation
Sponsored by
George Mason University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring arm, rehabilitation, non-invasive brain stimulation, transcranial magnetic stimulation, upper extremity

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MedStar National Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Unaffected Hemisphere

Affected Hemisphere

Control Site

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in maximum reaching distance
Percentage change in maximum distance participant is able to reach
Change in hand path kinematics
Percentage change in temporal and spatial movement of the hand during reaching

Full Information

First Posted
February 24, 2017
Last Updated
September 10, 2019
Sponsor
George Mason University
Collaborators
MedStar National Rehabilitation Network
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1. Study Identification

Unique Protocol Identification Number
NCT03067818
Brief Title
Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis
Official Title
Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
August 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
George Mason University
Collaborators
MedStar National Rehabilitation Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis, Cerebral Vascular Accident, Stroke, Ischemic
Keywords
arm, rehabilitation, non-invasive brain stimulation, transcranial magnetic stimulation, upper extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Masking Description
The individual that conducts the tests of arm movement will be unaware of which brain area was stimulated.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unaffected Hemisphere
Arm Type
Experimental
Arm Description
Application of "Unaffected Transcranial Magnetic Stimulation" to unaffected hemisphere site prior to physical practice
Arm Title
Affected Hemisphere
Arm Type
Experimental
Arm Description
Application of "Affected Transcranial Magnetic Stimulation" to affected hemisphere site prior to physical practice
Arm Title
Control Site
Arm Type
Active Comparator
Arm Description
Application of "Control Transcranial Magnetic Stimulation" to control site prior to practice
Intervention Type
Procedure
Intervention Name(s)
Unaffected Transcranial Magnetic Stimulation
Intervention Description
Non-invasive brain stimulation to unaffected hemisphere site prior to practice
Intervention Type
Procedure
Intervention Name(s)
Affected Transcranial Magnetic Stimulation
Intervention Description
Non-invasive brain stimulation to affected hemisphere site prior to practice
Intervention Type
Procedure
Intervention Name(s)
Control Transcranial Magnetic Stimulation
Intervention Description
Non-invasive brain stimulation to control site prior to practice
Primary Outcome Measure Information:
Title
Change in movement time
Description
Percentage change in time it takes to move the arm a standardized distance
Time Frame
Baseline and 1 Day
Secondary Outcome Measure Information:
Title
Change in maximum reaching distance
Description
Percentage change in maximum distance participant is able to reach
Time Frame
Baseline and 1 Day
Title
Change in hand path kinematics
Description
Percentage change in temporal and spatial movement of the hand during reaching
Time Frame
Baseline and 1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Harris-Love, PhD
Organizational Affiliation
George Mason University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar National Rehabilitation Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis

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