Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke

February 23, 2021 updated by: Lumy Sawaki, University of Kentucky
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • University of Kentucky at Cardinal Hill Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment
Time Frame: Baseline, Immediately post-intervention
This is a quantitative measure of motor recovery, coordination, and speed.
Baseline, Immediately post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm Test
Time Frame: 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.
Baseline, Immediately post-intervention
Stroke Impact Scale
Time Frame: 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.
Baseline, Immediately post-intervention
Cortical motor map volume
Time Frame: 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.
Baseline, Immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 23, 2016

Primary Completion (ACTUAL)

February 22, 2021

Study Completion (ACTUAL)

February 22, 2021

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (ACTUAL)

October 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 44185

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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