Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke

University of Kentucky12 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke

Interventions

Peripheral nerve stimulation (PNS)DEVICE

Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.

Intensive upper extremity motor trainingBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kentucky at Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Fugl-Meyer Assessment

This is a quantitative measure of motor recovery, coordination, and speed.

Time frame: Baseline, Immediately post-intervention

Secondary Outcomes

Action Research Arm Test

This test measures changes in the upper extremity and consists of four specific tests to measure grasp, grip, pinch, and gross movement.

Time frame: Baseline, Immediately post-intervention

Stroke Impact Scale

This is a self-report that assesses strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation.

Time frame: Baseline, Immediately post-intervention

Cortical motor map volume

This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand.

Time frame: Baseline, Immediately post-intervention

Data from ClinicalTrials.gov

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