Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jun 2017
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2017
CompletedFirst Posted
Study publicly available on registry
March 1, 2017
CompletedStudy Start
First participant enrolled
June 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2019
CompletedSeptember 11, 2019
September 1, 2019
2.2 years
February 24, 2017
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in movement time
Percentage change in time it takes to move the arm a standardized distance
Baseline and 1 Day
Secondary Outcomes (2)
Change in maximum reaching distance
Baseline and 1 Day
Change in hand path kinematics
Baseline and 1 Day
Study Arms (3)
Unaffected Hemisphere
EXPERIMENTALApplication of "Unaffected Transcranial Magnetic Stimulation" to unaffected hemisphere site prior to physical practice
Affected Hemisphere
EXPERIMENTALApplication of "Affected Transcranial Magnetic Stimulation" to affected hemisphere site prior to physical practice
Control Site
ACTIVE COMPARATORApplication of "Control Transcranial Magnetic Stimulation" to control site prior to practice
Interventions
Non-invasive brain stimulation to unaffected hemisphere site prior to practice
Non-invasive brain stimulation to affected hemisphere site prior to practice
Non-invasive brain stimulation to control site prior to practice
Eligibility Criteria
You may qualify if:
- More than 6 months post-stroke
- Loss of voluntary finger movement in the affected hand
- Some voluntary movement of affected shoulder and/or elbow
You may not qualify if:
- Brainstem or cerebellar stroke
- Severe cognitive or language deficits
- Epilepsy or other seizure disorder
- Central nervous system disease or disorder other than stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- George Mason Universitylead
- MedStar National Rehabilitation Networkcollaborator
Study Sites (1)
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Harris-Love, PhD
George Mason University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The individual that conducts the tests of arm movement will be unaware of which brain area was stimulated.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2017
First Posted
March 1, 2017
Study Start
June 20, 2017
Primary Completion
August 15, 2019
Study Completion
August 28, 2019
Last Updated
September 11, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share