High Definition Neuromuscular Stimulation in Tetraplegia
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|ClinicalTrials.gov Identifier: NCT04075812|
Recruitment Status : Completed
First Posted : September 3, 2019
Last Update Posted : September 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury at C4-C6 Level||Device: Neuromuscular Stimulator||Not Applicable|
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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm, open-label, non-controlled prospective intervention|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075812
|United States, Ohio|
|The Ohio State University Wexner Medical Center - Center for Neuromodulation|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Marcia Bockbrader, MD PhD||Ohio State University|