Combined augmented reality and electrical stimulation to improve hand and arm function after cervical spinal cord injury
Assessing the Feasibility and Safety of a Combined Closed Loop Functional Electrical Stimulation and Augmented Reality System for Individuals With Cervical Spinal Cord Injury
This project will test whether a combined augmented reality (AR) and functional electrical stimulation (FES) system can help people with chronic cervical spinal cord injury improve their upper-limb grasping and everyday hand use over 20 one-hour sessions.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 7 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07299734 on ClinicalTrials.gov |
What this trial studies
This early-phase pilot uses a combined AR+FES device to deliver upper-limb rehabilitation across 20 one-hour sessions delivered over 10 weeks, during which participants interact with virtual and real objects while targeted muscles are stimulated. The primary goals are to demonstrate safety by monitoring for serious adverse events and to show feasibility by confirming participants can set up and use the system independently. Secondary outcomes include adherence to the session schedule and structured user feedback on usability and experience. The study enrolls people with chronic cervical spinal cord injury who retain some ability to manipulate objects but have measurable impairment and is conducted at the Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic cervical spinal cord injury who can perform some object manipulations but show visible impairment (GRASSP prehension score 5–25), have muscles that respond to FES, no FES contraindications, and can follow study procedures.
Not a fit: People whose muscles do not respond to FES, who have contraindications to electrical stimulation (e.g., pacemaker, implanted neurostimulator, uncontrolled seizures), or who cannot attend the in-person sessions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the system could improve hand and arm function and increase independence with everyday tasks for people with cervical spinal cord injury.
How similar studies have performed: Non-invasive FES has shown benefit for upper-limb recovery in prior studies, but combining FES with augmented reality is a novel approach that remains largely untested in cervical SCI.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic cervical SCI * Any level or severity of cervical SCI, traumatic or non-traumatic * Can carry out object manipulations but with visible impairment (i.e., 5-25 on the GRASSP Prehension Performance sub-score). Exclusion Criteria: * Any disease or injury other than the SCI that may be affecting grasping performance. * Individuals with any self-reported FES contraindications (pacemakers, implantable defibrillator, implanted neurostimulation device, metallic implants in the stimulated areas, cardiac conditions, epilepsy, uncontrolled seizures, wounds or fractures on the target limb) * Inability to understand the study procedures * Muscles do not respond to FES to produce grasping movements * Currently participating in another upper limb rehabilitation intervention study (regular physical and occupational therapy is permitted).
Where this trial is running
Toronto, Ontario
- Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: José Zariffa, PhD — University Health Network, Toronto
- Study coordinator: Sharmini Atputharaj, MSc
- Email: Sharmini.Atputharaj@uhn.ca
- Phone: 416-597-3422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.