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High Definition Neuromuscular Stimulation in Tetraplegia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075812
Recruitment Status : Completed
First Posted : September 3, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Marcia Bockbrader, Ohio State University

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

Condition or disease Intervention/treatment Phase
Spinal Cord Injury at C4-C6 Level Device: Neuromuscular Stimulator Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, open-label, non-controlled prospective intervention
Masking: None (Open Label)
Primary Purpose: Other
Official Title: High Definition Neuromuscular Stimulation in Tetraplegia
Actual Study Start Date : April 25, 2013
Actual Primary Completion Date : June 21, 2019
Actual Study Completion Date : June 21, 2019

Arm Intervention/treatment
Experimental: 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.
Device: Neuromuscular Stimulator



Primary Outcome Measures :
  1. change in voluntary movement [ Time Frame: change in voluntary movement between baseline and final study visit: 12-60 months ]
    consistent and repetitive voluntary movement in the targeted muscle groups as assessed by investigator(s)- no formal scale is used


Secondary Outcome Measures :
  1. change in functional movement [ Time Frame: change in functional movement between baseline and final study visit: 12-60 months ]
    consistent movement in the targeted muscle groups that is functional (manipulate or pick up an object); as assessed by investigator(s) for task completion- no formal scale used



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075812


Locations
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United States, Ohio
The Ohio State University Wexner Medical Center - Center for Neuromodulation
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Marcia Bockbrader, MD PhD Ohio State University
Additional Information:
Publications of Results:

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Responsible Party: Marcia Bockbrader, Assistant Professor- Physical Medicine & Rehabilitation, Ohio State University
ClinicalTrials.gov Identifier: NCT04075812    
Other Study ID Numbers: 2013H0092
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Marcia Bockbrader, Ohio State University:
reanimation
stimulation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms