What side effects are associated with this type of intervention?

Repetitive Transcranial Magnetic Stimulation (rTMS) for spinal cord injury can cause mild side effects such as headaches, scalp discomfort, and, in rare cases, seizures, particularly in patients with epilepsy. Functional Electrical Stimulation (FES) Cycling may lead to skin irritation, muscle soreness, and fatigue. Both treatments are generally well-tolerated, but patients should be monitored for these potential side effects.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Spinal Cord Injury (SCI) that are directly analogous to rTMS or FES Cycling in the provided context. However, these therapies are being studied for their potential to enhance neural plasticity and improve muscle strength and coordination in SCI patients. Further research and clinical trials are necessary to establish their efficacy and safety for broader clinical use.

What other types of research exist?

Promising novel alternatives for SCI patients in 2024 include non-invasive neuromodulation therapies such as transcutaneous electrical nerve stimulation (TENS) and wearable robotic exoskeletons. TENS can enhance neural plasticity and recovery, while robotic exoskeletons can improve muscle strength and coordination by providing external support and facilitating movement.

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Procedure

Brain Stimulation + FES Cycling for Spinal Cord Injury

N/A

Recruiting

Research Sponsored by Western University, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of rTMS include discomfort at the stimulation site, headache, lightheadedness, and seizures in very rare cases. FES cycling may cause muscle fatigue and skin irritation beneath electrode sites.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of treatment-emergent adverse events

Number of dropouts in each group

Number of sessions attended by each participant

+3 more

Secondary study objectives

Cadence

Lower Extremity Motor Score (LEMS)

Postural sway test

+6 more

Other study objectives

Global Rating of Change (GRC) scale

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment groupExperimental Treatment2 Interventions

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

Group II: Control groupPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

repetitive transcranial magnetic stimulation (rTMS)

2003

Completed Phase 2

~380

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Repetitive Transcranial Magnetic Stimulation (rTMS) enhances neural plasticity and recovery by stimulating the brain's motor cortex, which can help rewire neural pathways and improve motor function. Functional Electrical Stimulation (FES) Cycling improves muscle strength and coordination by delivering electrical impulses to muscles, causing them to contract and thus promoting muscle activity and endurance. These treatments are significant for Spinal Cord Injury patients as they target both neural and muscular recovery, potentially leading to improved mobility and quality of life.

Effects of high frequency repetitive transcranial magnetic stimulation on KCC2 expression in rats with spasticity following spinal cord injury.