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NCT Number: NCT07445685

Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury.

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.

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Key information

Conditions

Incomplete Spinal Cord Injury (SCI)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan de Déu, Palma-Inca

Palma de Mallorca, Balearic Islands, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).
  • Unhealed fractures.
  • Pregnancy.
  • Active tumor process.

Treatment and study plan

Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12

Device

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 T12

Device

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,

Primary outcomes

  1. 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).

  2. 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

  3. 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.

  4. 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).

  5. 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).

  6. 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)

Secondary outcomes

  1. Penn Spasm Frequency Scale.

    Time frame: From the initial assessment to the end intervention after 4 weeks

    From 0 (no spasm) to 4 (Spasms occurring more than 10 times per hour)

  2. Modified Ashworth Spasticity Scale in knee extensors and plantar flexors.

    Time frame: From the initial assessment to the end intervention after 4 weeks.

    From 0 (No increase in muscle tone) to 4 (Affected part rigid in flexion or extension).

  3. Qualiveen questionnaire (Spanish version)

    Time frame: From the initial assessment to the end intervention after 4 weeks

    Negative impact on bladder function: from 0 (no impact) to 4 (maximum negative impact)

  4. Neurogenic Bowel Dysfunction (NBD) score (Spanish version)

    Time frame: From the initial assessment to the end intervention after 4 weeks

    From 0 to 47 points. Higher score = more severe neurogenic bowel dysfunction

Study contacts

Contact information is provided by the study sponsor or research team.

Luis Garcés-Pérez, MD, phD

CONTACT

[email protected]

+34 971 26 58 54

Susana Holub-Torres, MD

CONTACT

[email protected]

+34 971 26 58 54

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

  • Hospital San Juan de Dios, Spain

Registry information

Official study title

Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury: a Randomized, Double-blind Study.

Acronym: tSCS_SJD_PMI_1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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