Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke

• Sponsor: University of Kentucky (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04576013
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 3
• Actual Duration (Months): 60
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Peripheral nerve stimulation (PNS); Behavioral: Intensive upper extremity motor training	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke
• Actual Study Start Date: Feb 23, 2016
• Actual Primary Completion Date: Feb 22, 2021
• Actual Study Completion Date: Feb 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active PNS during training Individuals in this group will receive active PNS while participating in 2 hours of motor training of the affected arm.	Device: Peripheral nerve stimulation (PNS); 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.; Behavioral: Intensive upper extremity motor training
Active Comparator: Active PNS before training Individuals in this group will receive 2 hours of active PNS before participating in 2 hours of motor training of the affected arm.	Device: Peripheral nerve stimulation (PNS); 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.; Behavioral: Intensive upper extremity motor training
Sham Comparator: Sham PNS during training Individuals in this group will receive 2 hours of sham PNS while participating in 2 hours of motor training of the affected arm.	Device: Peripheral nerve stimulation (PNS); 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.; Behavioral: Intensive upper extremity motor training

Outcome Measures

Primary Outcome Measures

1. Fugl-Meyer Assessment [Baseline, Immediately post-intervention]

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

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky at Cardinal Hill Rehabilitation Hospital	Lexington	Kentucky	United States	40504

Sponsors and Collaborators

• University of Kentucky

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lumy Sawaki, Associate Professor, University of Kentucky
• ClinicalTrials.gov Identifier: NCT04576013
• Other Study ID Numbers: 44185
• First Posted: Oct 5, 2020
• Last Update Posted: Feb 25, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lumy Sawaki, Associate Professor, University of Kentucky: neuroplasticity; rehabilitation; peripheral nerve stimulation; motor training
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Feb 25, 2021