Brain Stimulation + FES Cycling for Spinal Cord Injury

Overseen By Siobhan Schabrun, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Orthopedic, Neurological, Implanted devices, others

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

Compensation: Varies

Number of Visits: 13

Duration: 6 weeks

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two therapies can improve leg function in people with incomplete spinal cord injuries. The therapies are repetitive Transcranial Magnetic Stimulation (rTMS), which uses magnetic fields to stimulate the brain, and Functional Electrical Stimulation (FES) Cycling, which uses electrical impulses to move the legs. One group will receive both therapies, while another group will receive sham (inactive) brain stimulation with real FES Cycling. The trial seeks participants who have had an incomplete spinal cord injury for at least a year and can walk 10 meters without assistance. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance rehabilitation options 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Functional Electrical Stimulation (FES) Cycling is generally safe for individuals with conditions like spinal cord injuries (SCI). Studies indicate it can enhance muscle health and fitness without major safety concerns. For instance, people with multiple sclerosis have safely used FES Cycling, even during intense activity.

Repetitive Transcranial Magnetic Stimulation (rTMS) also appears well-tolerated. Guidelines suggest it is safe for both healthy individuals and those with certain conditions, such as SCI. Early results are promising for its use in improving movement and managing pain.

Both treatments have demonstrated potential in past studies, but individual experiences can vary. Always consult healthcare professionals to understand what these findings might mean for participation in a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining Functional Electrical Stimulation (FES) Cycling and Repetitive Transcranial Magnetic Stimulation (rTMS) for spinal cord injury because it offers a unique approach to rehabilitation. Unlike standard treatments that primarily focus on physical therapy and medications, this method directly stimulates the brain and muscles. FES Cycling gets the muscles moving by delivering small electrical pulses, while rTMS uses magnetic fields to activate specific brain areas. This dual approach aims to enhance neuroplasticity, helping the body rewire itself more effectively after injury. This innovative combination could potentially speed up recovery and improve mobility in ways that traditional methods cannot.

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

Research shows that Functional Electrical Stimulation (FES) Cycling can help people with spinal cord injuries (SCI) by reducing muscle tightness, improving walking, and strengthening leg muscles. It also supports better muscle health and fitness. Studies have found that Repetitive Transcranial Magnetic Stimulation (rTMS) enhances feeling and movement, lessens muscle tightness, and boosts muscle strength in people with SCI. In this trial, one group of participants will receive active rTMS along with real FES cycling, while another group will receive sham rTMS with real FES cycling. Early evidence suggests that combining these treatments could provide greater benefits than using each one alone, as they target different aspects of muscle and nerve recovery. ^{1 4 5 6 7}

Who Is on the Research Team?

Siobhan Schabrun, PhD

Principal Investigator

Western University, Canada

Are You a Good Fit for This Trial?

This trial is for adults with incomplete spinal cord injury (SCI), classified as level C or D by the American Spinal Injury Association, who can walk 10 meters unaided. It's been at least a year since their non-progressive SCI occurred. People with other conditions affecting leg function or those with contraindications to rTMS or FES, like metal implants or severe osteoporosis, cannot participate.

Inclusion Criteria

My spinal cord injury is not getting worse.

I can walk 10 meters by myself without any help.

I have a spinal cord injury that is not fully paralyzing, and it's been over a year since the injury.

Exclusion Criteria

I have a condition affecting my leg function due to bone or nerve issues.

I don't have conditions like severe bone issues or implanted electronic devices that prevent FES use.

I don't have metal implants, a history of seizures, or cochlear implants.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active or sham rTMS followed by FES cycling twice per week

6 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Functional Electrical Stimulation (FES) Cycling
• Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview

The study tests how effective it is to combine repetitive Transcranial Magnetic Stimulation (rTMS) with Functional Electrical Stimulation (FES) Cycling on improving leg function in people with incomplete SCI compared to using each intervention alone. Participants are randomly assigned to different treatment groups.

How Is the Trial Designed?

Group I: Treatment group Experimental Treatment 2 Interventions

Participants of this group will receive active rTMS along with real FES cycling.

Group II: Control group Placebo Group 1 Intervention

Participants of this group will receive sham rTMS along with real FES cycling.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Published Research Related to This Trial

High frequency repeated transcranial magnetic stimulation (HF rTMS) therapy significantly improved motor function in patients with incomplete spinal cord injury, as evidenced by increased ASIA motor scores and lower extremities motor scores in a study of 103 patients.

HF rTMS therapy also reduced spasticity in the lower extremities, but did not show a significant effect on walking ability as measured by the Walking Index for Spinal Cord Injury II (WISCI II).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical effects of high frequency repeated transcranial magnetic stimulation therapy on dyskinesia in patients with incomplete spinal cord injury:a Meta-analysis]. Gao, ZC., Niu, BB., Gu, MC., et al.[2018]

Repetitive transcranial magnetic stimulation (rTMS) shows promise as a non-invasive treatment to enhance recovery and functional outcomes in individuals with spinal cord injury (SCI), with potential benefits for motor function and spasticity based on a review of 16 studies.

Future research should focus on optimizing rTMS parameters, such as timing and dosage, and emphasize the need for more rigorous studies comparing real versus sham rTMS to strengthen the evidence for its efficacy in SCI rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulation Parameters Used During Repetitive Transcranial Magnetic Stimulation for Motor Recovery and Corticospinal Excitability Modulation in SCI: A Scoping Review. Brihmat, N., Allexandre, D., Saleh, S., et al.[2022]

High-frequency repetitive transcranial magnetic stimulation (rTMS) significantly improved lower extremities motor score (LEMS) and various gait parameters in 17 patients with motor incomplete spinal cord injury after 15 sessions, with effects lasting for at least 2 weeks.

The active rTMS group showed notable improvements in spasticity and gait metrics, while the sham group did not demonstrate significant changes, highlighting the efficacy of rTMS as a therapeutic intervention for enhancing motor function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor and gait improvement in patients with incomplete spinal cord injury induced by high-frequency repetitive transcranial magnetic stimulation. Benito, J., Kumru, H., Murillo, N., et al.[2021]

In a study involving subjects with spinal cord injury (SCI), real repetitive transcranial magnetic stimulation (rTMS) did not show significant differences in the ASIA impairment scale compared to sham treatment, indicating limited efficacy in this specific measure.

However, rTMS did lead to short-term improvements in upper limb function as measured by the Action Research Arm Test (ARAT) and increased motor thresholds, suggesting that electrophysiological measures could be valuable in assessing functional changes in SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Action of 5 Hz repetitive transcranial magnetic stimulation on sensory, motor and autonomic function in human spinal cord injury. Kuppuswamy, A., Balasubramaniam, AV., Maksimovic, R., et al.[2011]

In a pilot study involving 11 participants with incomplete spinal cord injuries, the iCycle device, which combines Functional Electrical Stimulation (FES) with voluntary effort through virtual reality biofeedback, showed significant improvements in motor scores for some participants, particularly those with sub-acute injuries.

The study found that 4 out of 5 sub-acute participants and 2 out of 6 chronic participants improved their motor scores by more than 8 points, suggesting that the iCycle may enhance neurological recovery, although further controlled trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of FES cycling combined with virtual reality racing biofeedback on voluntary function after incomplete SCI: a pilot study. Duffell, LD., Paddison, S., Alahmary, AF., et al.[2020]

In a study involving 18 subjects with major depression, repetitive transcranial magnetic stimulation (rTMS) for up to 4 weeks was found to be generally safe, with no significant mean deficits in neuropsychologic function or auditory thresholds.

However, two patients experienced mild high-frequency hearing loss, indicating that while rTMS is safe for most, individual responses may vary and warrant further investigation into long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. Loo, C., Sachdev, P., Elsayed, H., et al.[2019]

Transcranial magnetic stimulation-based closed-loop (TBCL) therapy significantly improves activity of daily living (ADL) gains in spinal cord injury (SCI) patients compared to sole rehabilitation, with a lower cumulative inefficiency observed at 1, 90, and 180 days.

The study, which included 768 SCI patients, found that TBCL was an independent positive factor for ADL improvement across various injury types and severities, suggesting its broad applicability in rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation-based closed-loop modality for activity of daily living gain in spinal cord injury: a retrospective study using propensity score matching analysis. Liu, Y., Huang, B., Huang, G., et al.[2023]

Functional electrical stimulation (FES) cycling was found to be safe and well-tolerated in five patients with progressive multiple sclerosis (MS) over a six-month period, showing promising improvements in walking ability as measured by the Two Minute Walk Test and other mobility assessments.

Participants also experienced enhancements in quality of life, as indicated by improved scores on the Short-Form 36 (SF-36), suggesting that FES cycling may positively impact both physical and mental health in progressive MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of functional electrical stimulation cycling in progressive multiple sclerosis. Ratchford, JN., Shore, W., Hammond, ER., et al.[2022]

Citations

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jneuroengrehab.biomedcentral.com

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Evaluating the health and fitness benefits of a 6-month FES ...

This study aimed to evaluate the effects of a 6-month FES-cycling sport therapy using a recumbent trike on individuals with motor complete SCI.

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The purpose of our study was to develop a toolkit to facilitate the implementation of functional electrical stimulation (FES) cycling for persons with a newly ...

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frontiersin.org/journals/physiology/articles/10.3389/fphys.2021.756200/full

The Effect and Dose-Response of Functional Electrical ...

Functional electrical stimulation-cycling training can improve spasticity, walking ability, and the strength of the lower limbs in the individuals with SCI.

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pmc.ncbi.nlm.nih.gov

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

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

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0003999323002253

Effects of Functional Electrical Stimulation Cycling ...

During acute bouts of exercise, hybrid FES cycling was moderately more effective than ACE (effect size [ES] of 0.59 (95% CI 0.15-1.02, P=.008) in increasing V̇o ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2590109520300082

Safety and Feasibility of Various Functional Electrical ...

People with multiple sclerosis who are nonambulatory can safely perform functional electrical stimulation (FES) cycling using parameters requiring more effort.

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clinicaltrials.gov/study/NCT04412447

Training for Persons With Complete SCI for FES Cycling ...

The main objective of this study is to validate the effectivity of a simple home-based training for cycling with functional electrical stimulation (FES).