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Completed

NCT Number: NCT03067818

Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Vascular Accident Cerebrovascular Disorders Hemiparesis Ischemic Stroke Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke, Ischemic Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unaffected Transcranial Magnetic Stimulation

Procedure

Non-invasive brain stimulation to unaffected hemisphere site prior to practice

Affected Transcranial Magnetic Stimulation

Procedure

Non-invasive brain stimulation to affected hemisphere site prior to practice

Control Transcranial Magnetic Stimulation

Procedure

Non-invasive brain stimulation to control site prior to practice

Primary outcomes

  1. Change in movement time

    Time frame: Baseline and 1 Day

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

Secondary outcomes

  1. Change in maximum reaching distance

    Time frame: Baseline and 1 Day

    Percentage change in maximum distance participant is able to reach

  2. Change in hand path kinematics

    Time frame: Baseline and 1 Day

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

Sponsors and collaborators

Lead sponsor

George Mason University

Other

Collaborators

  • MedStar National Rehabilitation Network

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2017
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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