High Definition Neuromuscular Stimulation in Tetraplegia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-25

Study Completion Date

2019-06-21

Brief Summary

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The purpose of this study is to demonstrate high definition non-invasive neuromuscular stimulation of an upper extremity in tetraplegic participants.

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Detailed Description

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Spinal cord injury (SCI) is an insult to the spinal cord resulting in a change, either temporary or permanent, in its normal motor, sensory, and/or autonomic function. It is estimated that the annual incidence of spinal cord injury (SCI), not including those who die at the scene of the accident, is approximately 40 cases per million population in the U. S. or approximately 12,000 new cases each year.

The purpose of this study is to demonstrate high definition non-invasive neuromuscular stimulation of an upper extremity in tetraplegic participants. This study will plan to enroll up to 15 subjects who have been diagnosed with tetraplegia. The total duration of the study is expected to be about 18 months, and each participant is expected to be on the study for about 6 months.

The study design will consist of the following two (2) phases listed below. I. Baseline assessment and calibration (approximately 1 month) II. Testing motions: pre-sequenced and EEG-triggered motions; further calibration as needed (approximately 5 months)

Phase I - Baseline

* Medical history review
* Physical and neurological exam
* EMG
* Fit and calibrate external stimulator: The Battelle Neuromuscular Stimulator will be setup and calibrated to evoke wrist and hand/finger movements.

Phase II - Testing Motions After the Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements.

Conditions

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Spinal Cord Injury at C4-C6 Level

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm, open-label, non-controlled prospective intervention

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Neuromuscular Stimulator

Neuromuscular Stimulator is setup and calibrated, various spatial and temporal stimulation patterns will be tested to evoke wrist/hand movements in various sequences of individual and combined movements.

Group Type EXPERIMENTAL

Neuromuscular Stimulator

Intervention Type DEVICE

Interventions

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Neuromuscular Stimulator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Must be 21 years or older.

* Must be tetraplegic (C4-6 ASIA A)
* 12 months post injury and neurologically stable
* Participant is willing to comply with all follow-up evaluations at the specified times.
* Participant is able to provide informed consent prior to enrollment in the study.
* The participant is fluent in English.

Exclusion Criteria

* No active wound healing or skin breakdown issues.

* No history of poorly controlled autonomic dysreflexia.
* Other implantable devices such as heart/brain pacemakers
* Subjects who rely on ventilators

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No