Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis

Not Applicable

Terminated

• Conditions: Stroke; Hemiparesis

• Registration Number: NCT04574973
• Lead Sponsor: University of Kentucky

Brief Summary

Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation condition leads to the greatest improvement in hand and arm function.

Detailed Description

This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of four groups by chance. Three groups will receive tDCS at a level expected to increase the brain's ability to change, and will vary by the areas of the brain that are stimulated. The fourth group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their impaired arm and hand, focusing on exercises that will improve their ability to function in daily life.

Study Timeline

• Study Start: 2018-11-28
• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-02
• Study First Posted: 2020-10-05
• Status Verified: 2021-01
• Primary Completion: 2021-01-08
• Study Completion: 2021-01-08
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• 12 or more months post-stroke
• Inability to extend the affected metacarpophalangeal joints at least 10 degrees and the wrist 20 degrees

Exclusion Criteria

• Addition or change in dosage of drugs known to exert detrimental effects on motor recovery within 3 month of enrollment
• Untreated depression
• History of multiple strokes

Exclusion criteria for TMS evaluations:

• History of head injury with loss of consciousness
• History of severe alcohol or drug abuse, or psychiatric illness
• Positive pregnancy test or being of childbearing age and not using appropriate contraception
• Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain
• Cardiac or neural pacemakers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Fugl-Meyer Assessment from baseline	Baseline, Immediately post-intervention, one-month follow-up	This provides a quantitative measure of motor recovery, balance, sensation, coordination, and speed. An increase in score indicates an improvement in function.

Secondary Outcome Measures

Name	Time	Method
Change in cortical motor map from baseline	Baseline, Immediately post-intervention, one-month follow-up	This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm.
Change in Action Research Arm Test from baseline	Baseline, Immediately post-intervention, one-month follow-up	This consists of 4 tests to measure grasp, grip, pinch, and gross movement. An increase in score indicates an improvement in function.
Change in Stroke Impact Scale from baseline	Baseline, Immediately post-intervention, one-month follow-up	This is a self-report measure of 64 items that assess 8 domains, including strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation. A score increase indicates an improvement.

Trial Locations

Locations (1)

University of Kentucky at Cardinal Hill Rehabilitation Hospital; 🇺🇸 Lexington, Kentucky, United States