Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke

NCT ID: NCT04576013

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-23

Study Completion Date

2021-02-22

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active PNS during training

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

Group Type EXPERIMENTAL

Peripheral nerve stimulation (PNS)

Intervention Type 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 training

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Peripheral nerve stimulation (PNS)

Intervention Type 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 training

Intervention Type BEHAVIORAL

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.

Group Type SHAM_COMPARATOR

Peripheral nerve stimulation (PNS)

Intervention Type 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 training

Intervention Type BEHAVIORAL

Interventions

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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.

Intervention Type DEVICE

Intensive upper extremity motor training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kentucky

OTHER

Sponsor Role lead

Responsible Party

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Lumy Sawaki

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Kentucky at Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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44185

Identifier Type: -

Identifier Source: org_study_id

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