Spinal Cord Injury at C4-C6 Level
Conditions
Keywords
reanimation, stimulation
Brief summary
The purpose of this study is to demonstrate high definition non-invasive neuromuscular stimulation of an upper extremity in tetraplegic participants.
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.
Interventions
DEVICENeuromuscular Stimulator
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single arm, open-label, non-controlled prospective intervention
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Voluntary Movement | through study completion, up to 60 months | consistent and repetitive voluntary movement in the targeted muscle groups as assessed by investigator(s)- no formal scale is used. The participant(s) started out with paralysis due to spinal cord injury, so any active voluntary movement consists of a qualitative change in movement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Movement | through study completion, up to 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 Objects were taken from the Action Research Arm Task, Grasp and Release Task, GRASSP as well as using household objects (phone, cup, spoon) |
Countries
United States
Participant flow
Recruitment details
Recruited from Tertiary Care Center
Participants by arm
| Arm | Count |
|---|---|
| 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.
Neuromuscular Stimulator | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Neuromuscular Stimulator |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 31 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
Change in Voluntary Movement
consistent and repetitive voluntary movement in the targeted muscle groups as assessed by investigator(s)- no formal scale is used. The participant(s) started out with paralysis due to spinal cord injury, so any active voluntary movement consists of a qualitative change in movement.
Time frame: through study completion, up to 60 months
Population: All enrolled patients were able to generate consistent and repetitive movement in targeted muscle groups
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neuromuscular Stimulator | Change in Voluntary Movement | Evoked movement - able | 2 Participants |
| Neuromuscular Stimulator | Change in Voluntary Movement | Evoked movement - unable | 0 Participants |
Secondary
Change in Functional Movement
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 Objects were taken from the Action Research Arm Task, Grasp and Release Task, GRASSP as well as using household objects (phone, cup, spoon)
Time frame: through study completion, up to 60 months
Population: Consistent functional movement for object manipulation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neuromuscular Stimulator | Change in Functional Movement | Evoked object manipulation - able | 2 Participants |
| Neuromuscular Stimulator | Change in Functional Movement | Evoked object manipulation - unable | 0 Participants |