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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
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 moreSecondary study objectives
Change in bowel function measured by the NBDS
Change in cardiac structure and function
Change in corticospinal excitability
+14 moreTrial 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.
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.
Find a Location
Who is running the clinical trial?
Praxis Spinal Cord InstituteUNKNOWN
3 Previous Clinical Trials
58 Total Patients Enrolled
University of British ColumbiaLead Sponsor
1,463 Previous Clinical Trials
2,485,379 Total Patients Enrolled
Andrei Krassioukov, MD,PhD,FRCPCPrincipal InvestigatorUniversity of British Columbia
6 Previous Clinical Trials
158 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You need a ventilator to help you breathe.You have severe, untreated depression or are currently misusing drugs.You have an implanted pump that delivers baclofen into your spinal fluid.You take more than 30mg of oral baclofen or other anti-spasticity medications each day.You have heart, lung, bladder, or kidney problems that are not related to spinal cord injury, or you have a condition called hydronephrosis or obstructive renal stones.You have a serious health problem that would make it difficult for you to take part in the study, like a bad urinary tract infection or unstable diabetes.You have very low levels of hemoglobin in your blood, or have lost a lot of blood recently.You have had surgery to implant an electrode.You are between 18 and 60 years old, whether you are a man or a woman.You have a non-progressive spinal cord injury with complete motor paralysis at or above the T6 segment.You must be at least 1 year past your injury and at least 6 months past any spinal surgery.You have a spinal cord injury classified as AIS A or B.You can stand or sit up for 30 minutes without any problems.You don't have any ongoing muscle or bone pain, unhealed fractures, bedsores, or infections that could affect the tests.You have any metal implants in your head or devices like pacemakers or stimulators in your chest.You have a history of weak bones or fractures in your legs.You have a history of seizures, epilepsy, or frequent headaches.You have swollen, infected, or open wounds where the treatment would be applied.
Research Study Groups:
This trial has the following groups:- Group 1: ABT+SHAM
- Group 2: ABT+TSCS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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