Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke

Not Applicable

Terminated

• Conditions: Stroke

• Registration Number: NCT04576013
• Lead Sponsor: University of Kentucky

Brief Summary

Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group.

Detailed Description

This study will look at the differences in improvement of hand and arm function when nerve stimulation is applied at different times in relation to motor training. The nerve stimulation, called peripheral nerve stimulation (PNS), is non-invasive and painless. Subjects in the study may receive strong or mild PNS. Subjects will also vary by whether PNS is delivered for 2 hours before the 2 hours of motor training, or during the 2 hours of motor training. Which level of stimulation and its timing will be determined randomly for each subject.

Study Timeline

• Study Start: 2016-02-23
• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-05
• Status Verified: 2021-02
• Primary Completion: 2021-02-22
• Study Completion: 2021-02-22
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Have severe upper extremity motor deficit after a single stroke
• Stroke onset at least 12 months ago

Exclusion Criteria

• Addition or change in the dosage of drugs known to exert detrimental effects on motor recovery within 3 months of enrollment
• Untreated depression
• History of multiple strokes
• History of seizure
• History of head injury with loss of consciousness, 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 or implanted medication pumps
• Receptive aphasia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment	Baseline, Immediately post-intervention	This is a quantitative measure of motor recovery, coordination, and speed.

Secondary Outcome Measures

Name	Time	Method
Stroke Impact Scale	Baseline, Immediately post-intervention	This is a self-report that assesses strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation.
Cortical motor map volume	Baseline, Immediately post-intervention	This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand.
Action Research Arm Test	Baseline, Immediately post-intervention	This test measures changes in the upper extremity and consists of four specific tests to measure grasp, grip, pinch, and gross movement.

Trial Locations

Locations (1)

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