What is the mechanism of action of this treatment?

Transcutaneous Spinal Cord Stimulation (TSCS) is a non-invasive therapy that aims to 're-awaken' dormant spinal circuits by delivering electrical stimulation through the skin. This stimulation can enhance the strength of signals from the brain to the spinal cord, potentially improving motor functions such as seated balance and voluntary movement. Additionally, TSCS may positively impact autonomic functions, including cardiovascular, urinary, bowel, and sexual functions. For spinal cord injury patients, these improvements are crucial as they can significantly enhance quality of life and independence by restoring some degree of motor and autonomic control.

What side effects are associated with this type of intervention?

Transcutaneous Spinal Cord Stimulation (TSCS) and similar neuromodulation treatments for Spinal Cord Injury (SCI) are generally well-tolerated, with mild side effects. Common side effects include sensations of warmth, tingling, itching, and muscle spasms. Some patients may experience redness or discomfort at the site of electrode placement. Serious adverse events are rare. These treatments aim to re-awaken dormant spinal circuits and improve motor and autonomic functions, offering a promising option for individuals with SCI.

What prior FDA approvals exist?

The FDA has approved various neuromodulation techniques for the treatment of Spinal Cord Injury (SCI). One such treatment is Transcutaneous Electrical Nerve Stimulation (TENS), which has been used for pain management in SCI patients. Additionally, Spinal Cord Stimulation (SCS) has been approved for chronic pain relief in conditions like diabetic neuropathy, which shares some therapeutic principles with TSCS. While specific FDA approvals for TSCS in SCI are not detailed, these related neuromodulation therapies highlight the potential of electrical stimulation in re-awakening dormant spinal circuits and improving motor and autonomic functions.

What other types of research exist?

Promising, novel alternatives to Transcutaneous Spinal Cord Stimulation (TSCS) for Spinal Cord Injury (SCI) patients include: 1. Transcutaneous Supraorbital Nerve Stimulation, which has shown efficacy in reducing pain intensity in migraine patients and may have potential applications in SCI. 2. Remote Electrical Neuromodulation, which uses a device controlled by a smartphone to apply nonpainful electrical skin stimulation, showing significant pain relief in migraine trials. 3. Transcranial Magnetic Stimulation (TMS), which has demonstrated efficacy in treating migraine and may offer benefits for SCI patients by potentially improving motor and autonomic functions.

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Transcutaneous Spinal Cord Stimulation + Activity-Based Therapy for Spinal Cord Injury (MACHINE Trial)

N/A

Recruiting

Led By Andrei Krassioukov, MD,PhD,FRCPC

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 2 and 14

Summary

This trial will test if combining physical exercises with small electric currents applied to the skin can help people with severe spinal cord injuries improve their movement and bodily functions. The goal is to see if this combination works better than exercises alone. Functional electrical stimulation (FES) has been used to assist people with severe spinal cord injuries and to support recovery after spinal cord therapy.

Who is the study for?

This trial is for adults aged 18-60 in British Columbia with stable, chronic motor-complete spinal cord injury at or above T6 and no severe unrelated health issues. Participants must not be pregnant, lactating, or planning pregnancy and agree to use contraception. They should be able to tolerate upright posture for 30 minutes and have a stable medication dosage.

What is being tested?

The study tests if activity-based therapy (ABT) combined with transcutaneous spinal cord stimulation (TSCS) improves motor function and autonomic functions like cardiovascular stability and bladder control better than ABT alone in individuals with spinal cord injury.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, muscle spasms, skin irritation from electrodes, headache or dizziness during upright posture training. The severity of these side effects can vary among participants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 2 and 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 2 and 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2 and 14 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in attempted voluntary motor activation (supine)

Change in attempted voluntary motor activation (walking)

Change in blood pressure regulation

+1 more

Secondary study objectives

Change in bowel function measured by the NBDS

Change in cardiac structure and function

Change in corticospinal excitability

+14 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ABT+TSCSExperimental Treatment2 Interventions

Therapeutic TSCS will be delivered during ABT using an isolated bipolar constant current stimulator. Continuous TSCS applied over the T11-T12 spinous processes at 5-40 Hz has been shown to induce stepping movements in participants with their legs in a gravity-independent position.

Group II: ABT+SHAMPlacebo Group2 Interventions

The SHAM is low-intensity, ineffective stimulation delivered at the same anatomical location as TSCS.

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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

Transcutaneous Spinal Cord Stimulation (TSCS) is a non-invasive therapy that aims to 're-awaken' dormant spinal circuits by delivering electrical stimulation through the skin. This stimulation can enhance the strength of signals from the brain to the spinal cord, potentially improving motor functions such as seated balance and voluntary movement. Additionally, TSCS may positively impact autonomic functions, including cardiovascular, urinary, bowel, and sexual functions. For spinal cord injury patients, these improvements are crucial as they can significantly enhance quality of life and independence by restoring some degree of motor and autonomic control.