High Definition Neuromuscular Stimulation in Tetraplegia

The Ohio State University

Status: Completed

Conditions: Spinal Cord Injury at C4-C6 Level

Treatments: Device: Neuromuscular Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT04075812

2013H0092

Details and patient eligibility

About

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

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Neuromuscular Stimulator

Experimental group

Description:

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.

Treatment:

Device: Neuromuscular Stimulator