Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke

University of Kentucky

Status: Terminated

Conditions: Stroke

Treatments: Behavioral: Intensive upper extremity motor training; Device: Peripheral nerve stimulation (PNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04576013

44185

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 3 patient groups

Active PNS during training

Experimental group

Description:

Individuals in this group will receive active PNS while participating in 2 hours of motor training of the affected arm.

Treatment:

Device: Peripheral nerve stimulation (PNS)

Behavioral: Intensive upper extremity motor training

Active PNS before training

Active Comparator group

Description:

Individuals in this group will receive 2 hours of active PNS before participating in 2 hours of motor training of the affected arm.

Treatment:

Device: Peripheral nerve stimulation (PNS)

Behavioral: Intensive upper extremity motor training

Sham PNS during training

Sham Comparator group

Description:

Individuals in this group will receive 2 hours of sham PNS while participating in 2 hours of motor training of the affected arm.

Treatment:

Device: Peripheral nerve stimulation (PNS)

Behavioral: Intensive upper extremity motor training