Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury. (tSCS_SJD_PMI_1)

March 2, 2026 updated by: Luis Garces Perez, Fundació Sant Joan de Déu

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:

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Luis Garcés-Pérez, MD, phD
  • Phone Number: +34 971 26 58 54
  • Email: luis.garces@sjd.es

Study Contact Backup

Study Locations

  • Spain
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain
        • Hospital Sant Joan de Déu, Palma-Inca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active tSCS

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
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 Comparator: Sham tSCS

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
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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From the initial assessment to the end intervention after 4 weeks
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
From the initial assessment to the end intervention after 4 weeks
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.
From the initial assessment to the end intervention after 4 weeks
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).
From the initial assessment to the end intervention after 4 weeks
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).
From the initial assessment to the end intervention after 4 weeks
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)
From the initial assessment to the end intervention after 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
From 0 (No increase in muscle tone) to 4 (Affected part rigid in flexion or extension).
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
Negative impact on bladder function: from 0 (no impact) to 4 (maximum negative impact)
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
From 0 to 47 points. Higher score = more severe neurogenic bowel dysfunction
From the initial assessment to the end intervention after 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Sant Joan de Déu

Collaborators

Hospital San Juan de Dios, Spain

Investigators

  • Study Director: Manuel V Garnacho-Castaño, Professor Catedràtic, Campus Docent Sant Joan de Déu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IB 5797/25 PS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the individual participant data (IPD), age, sex, time from injury, level of injury, ethiology of injury, values of primary and secundary outcomes

IPD Sharing Time Frame

At the end of the study during 5 years

IPD Sharing Access Criteria

Researches from other institutions who contact the IP by mail requesting IPD of the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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