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

Launched by OHIO STATE UNIVERSITY · Oct 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the NeuroLife EMG-FES Sleeve System, which is designed to help people with cervical spinal cord injuries regain control of their hand movements. The system uses non-invasive technology, meaning it doesn’t require any surgeries or implants. Instead, it has sensors placed on the forearm that can both read muscle activity and stimulate the muscles to help improve grasping abilities. The trial will involve 12 adults with a condition known as tetraplegia, which means they have limited use of their arms and hands, and they will participate in a rehabilitation program over 12 weeks.

To be eligible for this study, participants must be at least 22 years old and have had a spinal cord injury for more than 12 months. They should be able to move their shoulders and elbows, even if they can’t grasp objects. Participants will attend sessions three times a week in Columbus, Ohio, and will undergo various assessments to measure their progress. This trial aims to determine how safe and effective this device is and whether it can help improve hand and arm function over time. If you or someone you know might be interested, it’s a great opportunity to explore new ways to enhance independence in daily activities.

Gender

ALL

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.