AR + FES for Broken Neck

Overseen By Sharmini Atputharaj, MSc

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University Health Network, Toronto

Disqualifiers: Other diseases, FES contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 23

Duration: 10 weeks

7 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with significant neck injuries regain better arm use. By combining augmented reality (AR) with functional electrical stimulation (FES, a therapy using electrical currents to stimulate nerves), the study aims to enhance daily arm function. Participants will attend 20 sessions over 10 weeks, interacting with objects to assess the safety and practicality of this approach. Individuals with chronic neck injuries who struggle with hand movements might be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative approach.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have any conditions that are contraindicated with FES, such as having a pacemaker or epilepsy, you may not be eligible to participate.

What prior data suggests that this device is safe for individuals with cervical spinal cord injury?

Research has shown that functional electrical stimulation (FES) is generally safe and well-tolerated. FES uses small, controlled electrical currents to help muscles move and has been safely used in various therapies. In other studies, people with spinal cord injuries who used FES did not report serious side effects.

This trial combines FES with augmented reality (AR) to aid arm and hand rehabilitation. Although using AR with FES is a newer approach, FES alone has a strong safety record. The study's main goal is to ensure no serious side effects occur, making safety a top priority. Participants will use the AR + FES system in short sessions, allowing for easier monitoring and management of any potential issues. Overall, current evidence supports the safety of FES, and this study carefully checks to ensure that adding AR does not alter that safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AR + FES for treating broken necks because it combines augmented reality (AR) with functional electrical stimulation (FES) to enhance rehabilitation. Unlike traditional treatments that primarily rely on physical therapy alone, this approach uses AR to create immersive visual environments that can boost motivation and engagement during exercises. Meanwhile, FES helps by stimulating muscles directly, promoting muscle strength and coordination more effectively than conventional methods. This innovative combination aims to speed up recovery and improve outcomes for patients with spinal injuries.

What evidence suggests that the AR + FES device is effective for cervical spinal cord injury?

Research has shown that functional electrical stimulation (FES) can improve hand movement in people with spinal cord injuries. One study with 24 participants found that combining FES with regular therapy greatly enhanced their ability to hold and grasp objects. This suggests FES might help people regain some use of their arms and hands. In this trial, participants will receive a combination of augmented reality (AR) and FES. Although limited information exists on using AR with FES, the idea is that AR could make therapy more engaging and effective. Early results appear promising, but further research is needed to confirm its benefits. ^{1 6 7 8 9}

Who Is on the Research Team?

José Zariffa, PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for individuals who have suffered a broken neck, specifically cervical spinal cord injury (cSCI), and are looking to improve their upper-limb function. Participants should be able to commit to 20 sessions over 10 weeks and use the AR + FES system independently.

Inclusion Criteria

I have a long-term spinal cord injury in my neck.

I have a spinal cord injury in my neck, regardless of how severe or how it happened.

I can use my hands but with some difficulty.

Exclusion Criteria

I have no other conditions affecting my ability to grasp.

My muscles can't make grasping movements with electrical stimulation.

I am not in another upper limb study but may be doing regular therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 session

1 visit (in-person)

Treatment

Participants undergo 20 experimental sessions using the AR + FES system for upper-limb rehabilitation

10 weeks

20 visits (in-person)

Discharge Assessment

Participants complete a discharge assessment including user feedback and clinical measures

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up assessments

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AR + FES

Trial Overview

The study tests a new device combining augmented reality (AR) with functional electrical stimulation (FES) during rehabilitation exercises. It aims to determine if it's safe and feasible for people with cSCI to use, by monitoring any serious adverse events and participants' ability to operate the system.

How Is the Trial Designed?

Group I: Single group Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Canadian Training Platform for Trials Leveraging Existing Networks

Collaborator

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07299734

Feasibility and Safety of a Combined Augmented Reality ...

Exploratory outcomes will examine preliminary efficacy using clinical measures such as the Spinal Cord Independence Measure (SCIM) and the ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9570914/

The Correlation between Cervical Fusion Length and ...

This study aims to assess if there is an evident correlation between fusion length and rehabilitation success after trauma to the cervical spine.

3.

frontiersin.org

frontiersin.org/journals/cellular-neuroscience/articles/10.3389/fncel.2023.1095259/full

Electrical stimulation for the treatment of spinal cord injuries

In 24 individuals within 6 months of SCI, FES combined with conventional occupational therapy significantly improved grasping function across a battery of ...

4.

nature.com

nature.com/articles/s41392-023-01477-6

Spinal cord injury: molecular mechanisms and therapeutic ...

Circulating neutrophil-to-lymphocyte ratio at admission predicts the long-term outcome in acute traumatic cervical spinal cord injury patients.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1529943019301664

Outcomes of posterior cervical fusion and decompression

Posterior cervical fusion with decompression resulted in significant clinical improvement, as indicated by the changes in patient-reported outcomes.

6.

ctv.veeva.com

ctv.veeva.com/study/feasibility-and-safety-of-a-combined-augmented-reality-and-functional-electrical-stimulation-system

Feasibility and Safety of a Combined Augmented Reality and ...

Evidence suggests that non-invasive neuromodulation such as functional electrical stimulation (FES) therapy can contribute to regaining upper- ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8196442/

Functional electrical stimulation cycling exercise after spinal ...

Current evidence indicates that FES cycling exercise improves lower-body muscle health of adults with SCI, and may increase power output and aerobic fitness.

8.

researchgate.net

researchgate.net/publication/396282313_Effects_of_Brain-Computer_Interface-Functional_Electrical_Stimulation_on_Functional_Recovery_in_Patients_with_Cervical_Spinal_Cord_Injury_A_Functional_Near-Infrared-Based_Study

Effects of Brain-Computer Interface-Functional Electrical ...

The purpose of this study was to explore the efficacy of functional electrical stimulation (FES) from BCIs on upper limb function and cerebral ...

9.

fescenter.org

fescenter.org/wp-content/uploads/2020/05/Report-to-the-Community-2019-web.pdf

Report to the Community 2019

Functional electrical stimulation (FES) is the use of small, artificially generated electrical currents that are safely and selectively applied to the central ...