Feasibility and Safety of a Combined Augmented Reality and Functional Electrical Stimulation System

University Health Network, Toronto

Status and phase: Enrolling; Early Phase 1

Conditions: Cervical Spinal Cord Injury

Treatments: Device: AR + FES

Study type: Interventional

Funder types: Other

Identifiers

NCT07299734

25-5898

Details and patient eligibility

About

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).

Enrollment: 7 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Single group

Experimental group

Description:

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).

Treatment:

Device: AR + FES