Clinical trial NCT06087445: A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia
Official title: A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Spinal Cord Injury
Keywords: cervical spinal cord injury
chronic SCI
functional electrical stimulation
electromyography
functional rehabilitation
biomarker
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Battelle Memorial Institute
First posted: 2023-10-17
Enrollment: 12
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants with chronic cervical spinal cord injury will complete a 12-week intervention protocol (3x/week) in an outpatient setting where they will practice functional activities using their hand/forearm while wearing the NeuroLife EMG-FES Sleeve System. We will assess functional outcomes using standardized clinical measures at 6 timepoints (double baseline, 4 weeks, 8 weeks, post-intervention, and 4 weeks post-intervention).
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this pilot clinical study is to investigate the NeuroLife EMG-FES Sleeve System, a closed-loop approach to functional electrical stimulation, in adults (n=12) with chronic (\>12 months) tetraplegia due to spinal cord injury. Briefly, the NeuroLife EMG-FES System is a completely non-invasive system (surface electrodes only, no implantable components) worn on the forearm which has up to 160 electrodes that can record electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. The main questions this study aims to answer are: 1) What is the safety, feasibility, and early efficacy of the NeuroLife EMG-FES system on upper extremity outcomes in chronic SCI survivors with tetraplegia, and 2) Can EMG be used as a biomarker of recovery over time in chronic SCI participants undergoing rehabilitation? Participants will complete an intensive, task-oriented rehabilitation protocol using the NeuroLife EMG-FES System (3x/week x 12 weeks) in an outpatient setting. We will assess functional outcomes using standardized clinical measures of hand and arm function at six timepoints.

Detailed description: In our prior work, members of our study team found that residual, sub-movement threshold EMG signals can be measured reliably from the forearm of chronically paralyzed individuals with spinal cord injury (SCI) using the NeuroLife EMG-FES System, and that EMG can be used to discriminate multiple attempted hand movements to drive continuous control of functional electrical stimulation (FES). Briefly, the NeuroLife EMG-FES System is a completely non-invasive system (surface electrodes only, no implantable components) worn on the forearm of participants and has up to 160 electrodes that can record electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. This allows users to attempt a movement and, even in the absence of physical movement, the system can detect what they are trying to do and electrically stimulate the muscles they are attempting to use. We hypothesize that this ability to control the system with participant's own muscle signals will assist in improving and restoring hand function of SCI survivors with tetraplegia. Furthermore, preliminary studies have suggested the potential for motor-intention driven FES to promote functional recovery after system use. With the dual-purpose use as a functional orthosis and as a rehabilitation tool for restoration of hand function, the NeuroLife EMG-FES System is poised to transform the state of care for those with hand impairment due to SCI.

The overarching goal of this proposal is to investigate the safety, feasibility, and early efficacy of the NeuroLife EMG-FES system on upper extremity outcomes in chronic SCI survivors with tetraplegia. A pilot clinical trial will allow us to test the following aims: Aim 1. Determine the early efficacy of using the NeuroLife EMG-FES System as a functional orthosis to complete functional activities after 12 weeks of task practice using the system. Aim 2. Determine the early efficacy of using the NeuroLife EMG-FES System as a rehabilitation tool to improve sensorimotor function after 12 weeks of task practice using the system. Aim 3. Develop and establish EMG-based biomarkers of neuroplasticity and recovery after chronic SCI.

We plan to conduct a pilot clinical trial investigating the NeuroLife EMG-FES Sleeve System in adults (n=12) with chronic (\>12 months) tetraplegia due to spinal cord injury. Briefly, the NeuroLife EMG-FES System is a completely non-invasive system (surface electrodes only, no implantable components) worn on the forearm of participants and has up to 160 electrodes that can record electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. Using this combined, closed-loop technology participants will complete a 12-week protocol with a study therapist practicing functional activities using their hand/forearm while wearing the NeuroLife EMG-FES Sleeve System. We will assess functional outcomes using standardized clinical measures at 6 timepoints (double baseline, 4 weeks, 8 weeks, post-intervention, and 4 weeks post-intervention). At these timepoints we will also collect high-definition EMG data using the NeuroLife EMG-only system to investigate the ability to use EMG as a biomarker of recovery over time in chronic SCI participants undergoing rehabilitation.

Eligibility criteria: Inclusion Criteria:

1. age 22 years or older
2. sustained a chronic (\>12 months) cervical SCI (AIS A, B, C, or D) and is currently medically stable
3. unable to grasp and manipulate objects to allow independent performance of activities of daily living (e.g., Tetraplegia)
4. retain voluntary ability to enact unilateral shoulder and elbow movements either independently or with a mobile arm support
5. Willing and able to attend study sessions in Columbus, Ohio for 12 weeks, 3x/week and all assessment sessions (4 weeks prior to and 4 weeks following 12-week intervention protocol)
6. able to provide informed consent.

Exclusion Criteria:

1. medical contraindications to FES (e.g., pacemaker or other implanted devices, uncontrolled seizure disorder, cancer or open wounds on hands)
2. severe, uncontrolled autonomic dysreflexia
3. comorbid medical condition that, in the opinion of the PI, that may impact participant safety or study results
4. severe upper extremity spasticity or contractures that prevent FES-evoked wrist and finger movements
5. ventilator dependent
6. pregnant or plan to become pregnant (females only)
7. actively participating in upper extremity rehabilitation.

Primary outcomes:
measure: Aim 1: Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) (Object Manipulation Subtest)
timeFrame: baseline to 4-week post-intervention follow-up
measure: Aim 2: Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP), v2
timeFrame: baseline to 4-week post-intervention follow-up
measure: Aim 3: Grasp and Release Test (GRT)
timeFrame: baseline to 4-week post-intervention follow-up
Secondary outcomes:
measure: Aim 1: Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP), v2 (Prehension Performance Subtest)
timeFrame: baseline to 4-week post-intervention follow-up
measure: Aim 2: Spinal Cord Independence Measure (SCIM)-III
timeFrame: baseline to 4-week post-intervention follow-up
Other outcomes:
measure: Expedited International Standards for Neurological Classification of SCI (E-ISNCSCI)
timeFrame: baseline to 4-week post-intervention follow-up
measure: Tetraplegia Upper Limb Activities Questionnaire (TUAQ)
timeFrame: baseline to 4-week post-intervention follow-up
measure: Demographics/History
timeFrame: baseline
Locations:
city: Columbus
country: United States
facility: Battelle Memorial Institute
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center (Columbus Campus, Dodd Hall, Martha Morehouse Medical Pavillion)
state: Ohio
Study officials:
affiliation: Ohio State University
name: Lauren Wengerd, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Battelle Memorial Institute
name: David Friedenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: