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

Trial Summary

What is the purpose of this trial?

This trial tests if combining brain and muscle electrical stimulation helps people with partial spinal cord injuries walk better by improving muscle strength and coordination. Functional electrical stimulation (FES) has been used to assist walking and improve muscle strength in individuals with 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 data supports the effectiveness of the treatment Brain Stimulation + FES Cycling for Spinal Cord Injury?

Research shows that repetitive transcranial magnetic stimulation (rTMS), a part of this treatment, can improve motor function and walking ability in people with incomplete spinal cord injuries. Studies suggest that rTMS can help restore some movement and reduce muscle stiffness, making it a promising option for spinal cord injury recovery. ^{1 2 3 4 5}

Is the combination of brain stimulation and FES cycling safe for humans?

Repetitive transcranial magnetic stimulation (rTMS), a type of brain stimulation, has been studied for safety in humans, including those with depression, and is generally considered safe when used in controlled settings. It is a non-invasive method and has been used in various conditions without major safety concerns. ^{1 2 4 6 7}

How is the treatment of Brain Stimulation + FES Cycling for Spinal Cord Injury different from other treatments?

This treatment is unique because it combines Functional Electrical Stimulation (FES) Cycling, which helps improve muscle function and strength, with Repetitive Transcranial Magnetic Stimulation (rTMS), which can enhance brain activity and promote neurological recovery. This combination aims to maximize recovery by stimulating both the brain and muscles, which is different from treatments that focus on only one of these areas. ^{2 8 9 10 11}

Research Team

Siobhan Schabrun, PhD

Principal Investigator

Western University, Canada

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Motor and gait improvement in patients with incomplete spinal cord injury induced by high-frequency repetitive transcranial magnetic stimulation. [2021]

2. Italy 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. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Action of 5 Hz repetitive transcranial magnetic stimulation on sensory, motor and autonomic function in human spinal cord injury. [2011]

4. China 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]. [2018]

5. Switzerland 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation improves open field locomotor recovery after low but not high thoracic spinal cord compression-injury in adult rats. [2021]

7. United States 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. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A pilot study of functional electrical stimulation cycling in progressive multiple sclerosis. [2022]

9. England 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. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Retraction of "Effects of High-Frequency Repetitive Transcranial Magnetic Stimulation on Motor and Gait Improvement in Incomplete Spinal Cord Injury Patients". [2019]

11. Austria pubmed.ncbi.nlm.nih.gov

FES cycling. [2019]