An interventional study of Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12 and Sham transcutaneous spinal cord stimulation on the dorsal region between T11 and T12 in Incomplete Spinal Cord Injury (SCI), sponsored by Fundació Sant Joan de Déu. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Fundació Sant Joan de Déu · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if transcutaneous spinal cord stimulation works to improve lower limb motor function in adults with incomplete spinal cord injury. It will also learn about the safety of transcutaneous spinal cord stimulation when combined with assisted cycling training.
The main questions it aims to answer are:
Does transcutaneous spinal cord stimulation while training with assisted cycling improve lower limb motor function? Does transcutaneous spinal cord stimulation while training with assisted cycling reduce muscle spasms or improve bladder or bowel function?
Researchers will compare transcutaneous spinal cord stimulation to a sham (a look-alike stimulation that does not deliver therapeutic electrical current) to see if transcutaneous spinal cord stimulation during assisted cycling improves motor function in people with incomplete spinal cord injury.
Participants will:
Participate in the training program with assisted cycling. Receive active stimulation or placebo stimulation during this training. Undergo motor function assessments, and be monitored about muscle spasms, bladder and bowel function and side effects.
The study will include 40 participants with incomplete spinal cord injury with less than 12 months since injury.
Project Title: Transcutaneous Electrical Spinal Cord Stimulation During Assisted Cycling Training for Incomplete Spinal Cord Injury. A Randomized Double-Blind Study.
Sponsor: Hospital Sant Joan de Déu Palma-Inca
Principal Investigator: Luis Garcés Pérez, MD. Attending Physician. Department of Rehabilitation. Hospital Sant Joan de Déu Palma-Inca
Study Site(s): Hospital Sant Joan de Déu Palma-Inca
Study Design: Randomized, double-blind, sham-controlled clinical trial
Condition or Disease Under Study: Spinal cord injury
Primary and Secondary Objectives:
The primary objective is to evaluate the effectiveness of transcutaneous spinal cord stimulation in improving lower limb motor function when used in combination with assisted cycling training.
Secondary objectives are to assess whether it has an effect on the frequency of muscle spasms and on bladder or bowel function.
Primary Outcome Measure: Lower Extremity Motor Score (LEMS) of the ASIA Impairment Scale for spinal cord injury.
Study Population and Total Number of Subjects: Individuals with incomplete spinal cord injury (ASIA B, C, or D) with less than 12 months since injury. A total of 40 subjects will be required for the study.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 40 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Fundació Sant Joan de Déu is the lead sponsor of 70 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ability to follow instructions and tolerate the intervention.
.-Spasticity grade less than 3 on the Modified Ashworth Scale.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active tSCS with biphasic rectangular current at 50 Hz with a 1 ms pulse width (0.5 ms per phase). 20 sessions training with assisted cycling, each lasting 45 minutes. Electrodes placed on the dorsal region between T11 and T12 and abdominal muscles,
Device: Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12
Sham tSCS, using decreasing intensity. Using biphasic rectangular current at 50 Hz with a 1 ms pulse width (0.5 ms per phase). Once the sensory threshold is reached, it will be maintained for 30 seconds and then gradually decreased. 20 sessions training with assisted cycling, each lasting 45 minutes. Electrodes placed on the dorsal region between T11 and T12 and abdominal muscles,
Device: Sham transcutaneous spinal cord stimulation on the dorsal region between T11 and T12
Active tSCS with Myomed 932 (ENRAF-NONIUS) using biphasic rectangular current at 50 Hz with a 1 ms pulse width (0.5 ms per phase). 20 sessions training with assisted cycling, each lasting 45 minutes. Electrodes placed on the dorsal region between T11 and T12 and abdominal muscles.
Sham tSCS, with Myomed 932 (ENRAF-NONIUS), using decreasing intensity. Using biphasic rectangular current at 50 Hz with a 1 ms pulse width (0.5 ms per phase). Once the sensory threshold is reached, it will be maintained for 30 seconds and then gradually decreased. 20 sessions training with assisted cycling, each lasting 45 minutes. Electrodes placed on the dorsal region between T11 and T12 and abdominal muscles,
Lower Extremity Motor Score (LEMS) according to the International Standards for Neurological Classification of Spinal Cord Injury.
From 0 (no muscular function) to 25 (normal muscular funcion).
Time frame: From the initial assessment to the end intervention after 4 weeks
Muscle strength (MRC scale) in knee extensors and plantar flexors
From 0 (no muscle function) to 5 (normal muscle function) for each muscle groups
Time frame: From the initial assessment to the end intervention after 4 weeks
Isometric dynamometric force of knee extensors and ankle dorsiflexors in both lower limbs
In a seated position with 90° knee flexion and ankle in neutral. The mean of three repetitions will be recorded.
Time frame: From the initial assessment to the end intervention after 4 weeks
10-Meter Walk Test (10MWT)
This will also be recorded as dichotomous variable (able/unable).
Time frame: From the initial assessment to the end intervention after 4 weeks
Timed Up and Go (TUG)
This will also be recorded as dichotomous variable (able/unable).
Time frame: From the initial assessment to the end intervention after 4 weeks
Walking Index for Spinal Cord Injury II (WISCI II)
From 0 (no walking function) to 20 (normal walking function without helping aids)
Time frame: From the initial assessment to the end intervention after 4 weeks
Penn Spasm Frequency Scale.
From 0 (no spasm) to 4 (Spasms occurring more than 10 times per hour)
Time frame: From the initial assessment to the end intervention after 4 weeks
Modified Ashworth Spasticity Scale in knee extensors and plantar flexors.
From 0 (No increase in muscle tone) to 4 (Affected part rigid in flexion or extension).
Time frame: From the initial assessment to the end intervention after 4 weeks.
Qualiveen questionnaire (Spanish version)
Negative impact on bladder function: from 0 (no impact) to 4 (maximum negative impact)
Time frame: From the initial assessment to the end intervention after 4 weeks
Neurogenic Bowel Dysfunction (NBD) score (Spanish version)
From 0 to 47 points. Higher score = more severe neurogenic bowel dysfunction
Time frame: From the initial assessment to the end intervention after 4 weeks
Plan to share: Yes — All the individual participant data (IPD), age, sex, time from injury, level of injury, ethiology of injury, values of primary and secundary outcomes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: At the end of the study during 5 years
Access criteria: Researches from other institutions who contact the IP by mail requesting IPD of the study.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Fundació Sant Joan de Déu