Feasibility of Home Based Transcutaneous Spinal Cord Stimulation for Persons With SCI

Launched by VA PALO ALTO HEALTH CARE SYSTEM · Nov 14, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new home-based program that uses a device called a transcutaneous neurostimulator to help improve arm and hand function in individuals with tetraplegia, which is paralysis caused by injury to the spinal cord. The program includes upper limb training and is supported through video calls with healthcare professionals. The goal is to see if this approach can effectively help people living with spinal cord injuries manage their condition from the comfort of their own homes.

To be eligible for this study, participants need to be veterans aged 18 to 65 who have experienced a cervical spinal cord injury. They should have some ability to move their arms and hands, and it’s important that they have someone at home who can help set up the device. Additionally, a good internet connection is needed for the video sessions. This trial is not yet recruiting participants, but if someone is considering joining, they will receive guidance and support throughout the process. Participants will also need to travel to the VA Palo Alto Medical Center for initial assessments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Veteran
• • 2. Age 18-65
• • 3. All gender, any ethnicity
• • 4. Cervical Spinal Cord Injury C2-8
• • 5. American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C or D
• • 6. GRASSP-Prehension Score \>10 or GRASSP Strength Score \>30
• • 7. Greater than 1 year post injury
• • 8. Able to identify a companion to assist with neurostimulator setup in home environment.
• • 9. Internet connection to support video telehealth connection
• • 10. Willingness to travel to the VA Palo Alto Medical Center
• Exclusion Criteria:
• • 1. Cardiopulmonary disease or cardiac symptoms,
• • 2. Autonomic dysreflexia that is uncontrolled or severe,
• • 3. Implanted medical device(s),
• • 4. Uncontrolled spasms that could limit participation in exercise training,
• • 5. Skin breakdown or active pressure injury in areas of electrode placement.
• • 6. Participants must not be engaged in any concurrent drug or device trial
• • 7. Pregnant, are planning to become pregnant, or breastfeeding
• • 8. The study is not deemed safe or appropriate in the opinion of the investigators