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

Official title

Assessing the Feasibility and Safety of a Combined Closed Loop Functional Electrical Stimulation and Augmented Reality System for Individuals With Cervical Spinal Cord Injury

Overview

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).

Interventions

• Device 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 measures

• 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.]

Secondary outcome measures (2)

• Adherence [Time frame: During experimental sessions from week 1 to week 10.]
• User feedback [Time frame: Discharge assessment at week 10.]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

Canada · 1 center

• Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network — Toronto

Identifiers

NCT: NCT07299734 · 25-5898

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗