Incomplete Spinal Cord Injury (SCI)tSCS_SJD_PMI_1NCT07445685
Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury.
A study testing Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12 in people with Incomplete Spinal Cord Injury (SCI), run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incomplete Spinal Cord Injury (SCI)
- What is being tested?
- Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18.
- Diagnosis of spinal cord injury at levels C2-T11, classified as ASIA Impairment Scale grades B, C, or D.
- Less than 1 year since the injury.
- Ability to follow instructions and tolerate the intervention.
- .-Spasticity grade less than 3 on the Modified Ashworth Scale.
- Signed informed consent.
Who cannot join
- Comorbidities that limit active participation (severe heart disease, serious active infections, pressure ulcers in the area).
- Use of devices incompatible with electrical stimulation.
- Metallic implant in the T11-T12 area.
- History of epilepsy.
- Fixed joint contractures limiting range of motion.
- Significantly reduced bone density (osteoporosis).
Show all 9Show fewer
- Unhealed fractures.
- Pregnancy.
- Active tumor process.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Sant Joan de Déu, Palma-Inca
Palma de Mallorca, Balearic Islands
About this study
Official title: Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury: a Randomized, Double-blind Study.
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Incomplete Spinal Cord Injury (SCI)
- Being tested
- Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12, Sham transcutaneous spinal cord stimulation on the dorsal region between T11 and T12
- Keywords
- Incomplete Spinal Cord Injury, Transcutaneous Electrical Spinal Cord Stimulation, Cycling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12Device
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 transcutaneous spinal cord stimulation on the dorsal region between T11 and T12Device
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,
| Study group | Role | What they receive |
|---|---|---|
| Active tSCS | Experimental | 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, Receives: Device: Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12 |
| Sham tSCS | Sham comparator | 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, Receives: Device: Sham transcutaneous spinal cord stimulation on the dorsal region between T11 and T12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: From the initial assessment to the end intervention after 4 weeks
Secondary outcomes (4)
Penn Spasm Frequency Scale.
From 0 (no spasm) to 4 (Spasms occurring more than 10 times per hour)
Measured: 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).
Measured: 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)
Measured: 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
Measured: From the initial assessment to the end intervention after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Incomplete Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind,sham-controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital San Juan de Dios, Spain
- Responsible party
- Principal investigator, Luis Garces Perez, Fundació Sant Joan de Déu
- Investigators
- Manuel V Garnacho-Castaño, Professor Catedràtic, Study director, Campus Docent Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445685
- Sponsor's protocol ID
- IB 5797/25 PS
- Acronym
- tSCS_SJD_PMI_1
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the individual participant data (IPD), age, sex, time from injury, level of injury, ethiology of injury, values of primary and secundary outcomes
Publications
Comino-Suarez N, Moreno JC, Megia-Garcia A, Del-Ama AJ, Serrano-Munoz D, Avendano-Coy J, Gil-Agudo A, Alcobendas-Maestro M, Lopez-Lopez E, Gomez-Soriano J. Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trial. J Neuroeng Rehabil. 2025 Jan 30;22(1):15. doi: 10.1186/s12984-025-01545-8.
PubMed 39885542Dewsbury DA, Oglesby JM, Shea SL, Connor JL. Inbreeding and copulatory behavior in house mice: a further consideration. Behav Genet. 1979 May;9(3):151-63. doi: 10.1007/BF01071298.
PubMed 496796
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury: a Randomized, Double-blind Study.
- ClinicalTrials.gov ID
- NCT07445685
- Acronym / sponsor ID
- tSCS_SJD_PMI_1 / IB 5797/25 PS
- Conditions
- Incomplete Spinal Cord Injury (SCI)
- Keywords
- Incomplete Spinal Cord Injury, Transcutaneous Electrical Spinal Cord Stimulation, Cycling
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Hospital San Juan de Dios, Spain
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind,sham-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Active tSCS | Experimental | Device: Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12Active 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, |
| Sham tSCS | Sham comparator | Device: Sham transcutaneous spinal cord stimulation on the dorsal region between T11 and T12Sham 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, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age at least 18.
- Diagnosis of spinal cord injury at levels C2-T11, classified as ASIA Impairment Scale grades B, C, or D.
- Less than 1 year since the injury.
- Ability to follow instructions and tolerate the intervention.
- .-Spasticity grade less than 3 on the Modified Ashworth Scale.
Key exclusion criteria (9 listed)
- Comorbidities that limit active participation (severe heart disease, serious active infections, pressure ulcers in the area).
- Use of devices incompatible with electrical stimulation.
- Metallic implant in the T11-T12 area.
- History of epilepsy.
- Fixed joint contractures limiting range of motion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12Active 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. | Device | Active tSCS |
| Sham transcutaneous spinal cord stimulation on the dorsal region between T11 and T12Sham 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, | Device | Sham tSCS |
Primary outcome
Lower Extremity Motor Score (LEMS) according to the International Standards for Neurological Classification of Spinal Cord Injury.
Time frame: From the initial assessment to the end intervention after 4 weeks
From 0 (no muscular function) to 25 (normal muscular funcion).
Muscle strength (MRC scale) in knee extensors and plantar flexors
Time frame: From the initial assessment to the end intervention after 4 weeks
From 0 (no muscle function) to 5 (normal muscle function) for each muscle groups
Isometric dynamometric force of knee extensors and ankle dorsiflexors in both lower limbs
Time frame: From the initial assessment to the end intervention after 4 weeks
In a seated position with 90° knee flexion and ankle in neutral. The mean of three repetitions will be recorded.
10-Meter Walk Test (10MWT)
Time frame: From the initial assessment to the end intervention after 4 weeks
This will also be recorded as dichotomous variable (able/unable).
Timed Up and Go (TUG)
Time frame: From the initial assessment to the end intervention after 4 weeks
This will also be recorded as dichotomous variable (able/unable).
Walking Index for Spinal Cord Injury II (WISCI II)
Time frame: From the initial assessment to the end intervention after 4 weeks
From 0 (no walking function) to 20 (normal walking function without helping aids)
4 secondary outcomes
Penn Spasm Frequency Scale.
Time frame: From the initial assessment to the end intervention after 4 weeks
Modified Ashworth Spasticity Scale in knee extensors and plantar flexors.
Time frame: From the initial assessment to the end intervention after 4 weeks.
Qualiveen questionnaire (Spanish version)
Time frame: From the initial assessment to the end intervention after 4 weeks
Neurogenic Bowel Dysfunction (NBD) score (Spanish version)
Time frame: From the initial assessment to the end intervention after 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 39885542Comino-Suarez N, Moreno JC, Megia-Garcia A, Del-Ama AJ, Serrano-Munoz D, Avendano-Coy J, Gil-Agudo A, Alcobendas-Maestro M, Lopez-Lopez E, Gomez-Soriano J. Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trial. J Neuroeng Rehabil. 2025 Jan 30;22(1):15. doi: 10.1186/s12984-025-01545-8.
- Background: PubMed 496796Dewsbury DA, Oglesby JM, Shea SL, Connor JL. Inbreeding and copulatory behavior in house mice: a further consideration. Behav Genet. 1979 May;9(3):151-63. doi: 10.1007/BF01071298.
- Individual participant dataSharing planned: Yes. All the individual participant data (IPD), age, sex, time from injury, level of injury, ethiology of injury, values of primary and secundary outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manuel V Garnacho-Castaño, Professor Catedràtic study director
Campus Docent Sant Joan de Déu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12 in people with Incomplete Spinal Cord Injury (SCI), run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Garcés-Pérez, MD, phD (+34 971 26 58 54, luis.garces@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Motor Score (LEMS) according to the International Standards for Neurological Classification of Spinal Cord Injury. (time frame: From the initial assessment to the end intervention after 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07445685, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.