FES Therapy + Task-Specific Training for Spinal Cord Injury

Overseen By Lamisa Etu, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Neurological diseases, Mental illness, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the timing of combining functional electrical stimulation therapy (which uses electrical currents to stimulate nerves) with task-specific training can improve recovery after a spinal cord injury. Participants will be divided into two groups: one will start the treatment 3 to 6 months after their injury, and the other will begin 6 to 9 months post-injury. The trial aims to determine which timing leads to better functional and neurological recovery. It seeks individuals who have experienced a motor incomplete spinal cord injury affecting their neck within the last 3 months. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance recovery strategies for spinal cord injuries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this therapy is safe for spinal cord injury patients?

Research has shown that functional electrical stimulation (FES) therapy combined with task-specific training (TST) is generally safe and well-tolerated. One study found that using automated FES to assist with walking was safe and well-received by participants. This suggests that combining FES and TST does not lead to serious side effects.

FES therapy has also been used successfully in individuals with paralysis from spinal cord injuries or strokes, supporting its safety. However, evidence on its effectiveness in improving arm and hand function is mixed, indicating a need for further research.

In summary, while FES with TST appears safe, its effectiveness can vary, and additional studies are necessary for a clearer understanding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about FEST+TST for spinal cord injury because it combines two innovative approaches: Functional Electrical Stimulation Therapy (FES) and Task-Specific Training (TST). Unlike traditional rehabilitation methods, which might focus on general strength and conditioning, this treatment specifically targets nerve and muscle activation through electrical stimulation while simultaneously training patients to perform everyday tasks. This dual-action approach aims to enhance neural recovery and improve motor function more effectively and rapidly than current therapies. By potentially facilitating more targeted and faster rehabilitation, FEST+TST represents a promising advancement in spinal cord injury recovery.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that functional electrical stimulation (FES) combined with task-specific training (TST) can improve movement and function in people with spinal cord injuries. In this trial, participants will receive either Early FEST + TST or Delayed FEST + TST. Studies indicate that FES can assist those with paralysis due to spinal cord injuries or strokes. Moderate evidence suggests that FES can enhance upper limb function, although some study results vary. Together, FES and TST can positively impact the system controlling muscle movements. These findings suggest that this combined therapy could effectively aid recovery after a spinal cord injury. ^{1 2 3 4 6}

Who Is on the Research Team?

Julio Furlan, MD, PhD

Principal Investigator

KITE, Toronto Rehab-University Health Network

Are You a Good Fit for This Trial?

This trial is for individuals in the early stages (less than 3 months) after a traumatic spinal cord injury at the neck level that still allows for some movement. It's not suitable for those with other medical conditions affecting treatment, neurological diseases, severe mental illness, learning disabilities, recent substance abuse, MRI contraindications, or sensory deficits impacting tests.

Inclusion Criteria

My spinal cord injury is recent, partial, and in the neck area.

Exclusion Criteria

I do not have any health conditions that prevent me from receiving FEST.

I have a neurological condition like peripheral neuropathy.

Contraindication to MRI scanning

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Treatment

Participants receive FEST+TST at 3 to 6 months from SCI onset

3 months

Delayed Treatment

Participants receive FEST+TST at 6 to 9 months from SCI onset

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• FEST+TST

Trial Overview The study examines if the timing of functional electrical stimulation therapy combined with task-specific training (FEST+TST) affects recovery of function and nerve health following a cervical spinal cord injury.

How Is the Trial Designed?

Group I: Early FEST + TST Experimental Treatment 1 Intervention

Participants will receive FEST+TST at 3 to 6 months from SCI onset.

Group II: Delayed FEST + TST Experimental Treatment 1 Intervention

Participants will receive FEST+TST at 6 to 9 months from SCI onset.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

In a study involving 12 individuals with complete spinal cord injury, FES-assisted dynamic load-shifting exercises led to significant increases in trabecular bone mineral density (vBMD) in the proximal and distal tibia after 29 weeks of training, indicating potential benefits for bone health in this population.

While improvements were noted in the tibia, there was no increase in vBMD in the distal femur, suggesting that the effectiveness of FES exercises may vary by bone location and type of exercise performed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of Functional Electrical Stimulation-assisted posture-shifting in bone mineral density: case series-pilot study. Armengol, M., Zoulias, ID., Gibbons, RS., et al.[2022]

In a study involving 72 spinal cord injury patients, functional electrical stimulation (FES) combined with robot-assisted training significantly improved both FES-assisted and voluntary muscle strength in the lower limbs, indicating enhanced motor function.

The results showed a strong correlation between increases in FES-assisted strength and voluntary muscle function, suggesting that this combined approach may effectively support recovery of residual functions after spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted training with functional electrical stimulation enhances lower extremity function after spinal cord injury. Bersch, I., Alberty, M., Fridén, J.[2022]

Citations

1. withpower.com withpower.com/trial/phase-spinal-cord-injuries-1-2022-dca4b

FES Therapy + Task-Specific Training for Spinal Cord Injury Research shows that using functional electrical stimulation (FES) with other therapies can improve movement and function in people with spinal cord injuries.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04910204

Time-effect of FEST+TST in the Upper-extremity ... The purpose of this study is to investigate whether the timing of delivery of functional electrical stimulation therapy in combination with task-specific ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7364342/

Functional Electrical Stimulation Therapy for Retraining ... The FES therapy protocols can be successfully applied to individuals with paralysis resulting from stroke or spinal cord injury.

4. tandfonline.com tandfonline.com/doi/full/10.1080/10833196.2025.2528408

Functional electrical stimulation for improving upper limb ... Overall, moderate evidence supports using FES for SCI upper limb function improvements but conflicting evidence remains. Future research into combination FES ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715922002884

Insights on the Potential Mechanisms of Action ... The results of this scoping review suggest that FEST + TST can result in multiple effects on different elements of the neuromuscular system.

6. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/42638

Feasibility and safety of automated multi-channel FES ... Automated multi-channel functional electrical stimulation-assisted gait training was feasible, safe, and well received.