CompletedNot Applicable

Effects of Transcutaneous Spinal Cord Stimulation on Residual Voluntary Motor Control in Individuals With Incomplete Spinal Cord Injury

Switzerland10 participantsStarted 2017-10-01

Plain-language summary

Recently, a transcutaneous protocol of electrical spinal cord stimulation (tSCS) has been developed. It was suggested, that this method could be used to improve the therapy process after a spinal cord injury (SCI). The aim of this study is to investigate the immediate effects of tSCS with different stimulation modalities on voluntary motor control in patients with incomplete SCI.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with incomplete SCI * Chronic (≥ 12 months post-injury) or subacute (≥ 3 months post-injury) stage of recovery * Age: ≥18 years * Able to complete the 10mWT with walking aids as required but no physical assistance * Neurological level of SCI: above T12 * Preserved segmental and cutaneo-muscular reflexes in the lower limbs * Bodyweight \> 20 kg and \< 120 kg * Mini-Mental state examination score 6 (test only performed if cognitive deficits are suspected) Exclusion Criteria: * Any other neurological diseases * Current orthopedic problems * Premorbid major depression or psychosis * History of significant autonomic dysreflexia with treatment * Dermatological issues (e.g. decubitus) at the stimulation or harness attachment site (back, abdomen, upper legs) * Active implants (e.g. cardiac pacemaker, implanted drug pump) * Passive implants at vertebral level T9 or more caudal vertebrae (metal screws and plates for surgical stabilization of spinal fractures) * Malignant diseases * Heart insufficiency NYHA III-IV * Potential pregnancy (pregnancy test must be conducted before each session) * Unlikely to complete the intervention or return for follow-up * Participation in another training study * Contraindications for BWS training using the FLOAT (according the manual): * No responsiveness * Severe muscle contractures * Acute fractures * Osteoporosis or osteogenesis imperfecta * Body size shorter than 1 meter or taller than 2 meters

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Kinematic movement characteristics recorded with a motion capture system;

Timeframe: Baseline and intervention of a specific task will be assessed directly after each other in a single session. All movement tasks will be split into 2 sessions within 2 weeks. The start of the first session is variable.

Trial details

NCT IDNCT03137108

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-12

View on ClinicalTrials.gov More Motor Control in Incomplete Spinal Cord Injured Persons trials