Recruiting
Early Phase 1

AR & FES

Sponsor:

University Health Network, Toronto

Code:

NCT07299734

Conditions

Cervical Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

AR + FES

Study Details

Brief summary:

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).

Conditions

Cervical Spinal Cord Injury

Study ID

NCT07299734

Start date

Jan, 2026

Status verified date

Nov, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

7 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Single group

Participants will go through 1 screening session, 20 experimental sessions (2 sessions per week for 10 weeks), 1 discharge assessment, and 1 follow up assessment (one month after the last experimental session).

Interventions

AR + FES

Within each one-hour experimental session, participants will interact with different objects (e.g. block, credit card, marble). They will be wearing an augmented reality (AR) headset and electrodes will be placed over finger flexors, thumb flexors and finger extensors muscles. The AR headset will track hand posture and use the difference between the actual posture and a target posture to regulate functional electrical stimulation (FES) delivered via the electrodes.

Primary outcome measure

  • Adverse events [ Time Frame: Week 1 to week 14. ]
  • Feasibility - Set-up time [ Time Frame: During experimental sessions from week 1 to week 10. ]
  • Feasibility - Assistance required. [ Time Frame: During experimental sessions from week 1 to week 10. ]

Central Contacts and Locations

Central contacts

Locations

Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network

Recruiting

Toronto, Ontario, Canada

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 23, 2025

Last verified

Nov, 2025

Keywords

  • Cervical spinal cord injury
  • Augmented reality
  • Functional electrical stimulation
  • Neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-12-23.