Feasibility and Safety of a Combined Augmented Reality and Functional Electrical Stimulation System (NCT07299734)
Assessing the Feasibility and Safety of a Combined Closed Loop Functional Electrical Stimulation and Augmented Reality System for Individuals With Cervical Spinal Cord Injury
🩺 Plain-English Summary (8th-Grade Level)
Cervical spinal cord injury (cSCI) can result in substantial loss of upper-limb function, with associated socio-economic impact on affected individuals and the healthcare system. Evidence suggests that non-invasive neuromodulation such as functional electrical stimulation (FES) therapy can contribute to regaining upper-limb function, which is a top priority for this population. This pilot study will involve individuals with cSCI using a device that combines augmented reality (AR) and functional electrical stimulation (FES) for 20, one-hour sessions over a 10-week period. The sessions will include upper-limb rehabilitation where individuals will interact with different objects with the aid of the AR +FES system. The primary objective is to assess safety and feasibility, measured by the absence of serious adverse events and participants' ability to independently set up and use the system. Secondary objectives include adherence to the intervention and user feedback through structured interviews. Exploratory outcomes will examine preliminary efficacy using clinical measures such as the Spinal Cord Independence Measure (SCIM) and the Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).
Who can join: Review the eligibility criteria below.
Location: Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network — Toronto, Ontario
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 597-3422
Email: Sharmini.Atputharaj@uhn.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Cervical Spinal Cord Injury
- Incomplete Cervical SCI Without Instability — San Francisco, California
- Spinal Cord Neuromodulation for Spinal Cord Injury — Los Angeles, California
- Rebuilding Inter-limb Transfer in Cervical SCI — Cleveland, Ohio
- Spinal Cord Associative Plasticity Study — New York, New York
- Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation — Tlalpan, Mexico City
Explore by condition: All Cervical Spinal Cord Injury clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.