RECRUITING

A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia

Quick Facts

Study Start:2023-10-31
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06087445

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. age 22 years or older
  2. 2. sustained a chronic (\>12 months) cervical SCI (AIS A, B, C, or D) and is currently medically stable
  3. 3. unable to grasp and manipulate objects to allow independent performance of activities of daily living (e.g., Tetraplegia)
  4. 4. retain voluntary ability to enact unilateral shoulder and elbow movements either independently or with a mobile arm support
  5. 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. 6. able to provide informed consent.
  1. 1. medical contraindications to FES (e.g., pacemaker or other implanted devices, uncontrolled seizure disorder, cancer or open wounds on hands)
  2. 2. severe, uncontrolled autonomic dysreflexia
  3. 3. comorbid medical condition that, in the opinion of the PI, that may impact participant safety or study results
  4. 4. severe upper extremity spasticity or contractures that prevent FES-evoked wrist and finger movements
  5. 5. ventilator dependent
  6. 6. pregnant or plan to become pregnant (females only)
  7. 7. actively participating in upper extremity rehabilitation.

Contacts and Locations

Study Contact

Lauren Wengerd, PhD
CONTACT
330-464-9171
lauren.wengerd@osumc.edu
David Friedenberg, PhD
CONTACT
614-424-5213
friedenbergd@battelle.org

Principal Investigator

Lauren Wengerd, PhD
PRINCIPAL_INVESTIGATOR
Ohio State University
David Friedenberg, PhD
PRINCIPAL_INVESTIGATOR
Battelle Memorial Institute

Study Locations (Sites)

Battelle Memorial Institute
Columbus, Ohio, 43201
United States
Ohio State University Wexner Medical Center (Columbus Campus, Dodd Hall, Martha Morehouse Medical Pavillion)
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

  • Lauren Wengerd, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University
  • David Friedenberg, PhD, PRINCIPAL_INVESTIGATOR, Battelle Memorial Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-31
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-10-31
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • cervical spinal cord injury
  • chronic SCI
  • functional electrical stimulation
  • electromyography
  • functional rehabilitation
  • biomarker

Additional Relevant MeSH Terms

  • Cervical Spinal Cord Injury