NCT07445685

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

February 25, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

February 25, 2026

Last Update Submit

March 2, 2026

Conditions

Incomplete Spinal Cord Injury (SCI)

Keywords

Incomplete Spinal Cord InjuryTranscutaneous Electrical Spinal Cord StimulationCycling

Outcome Measures

Primary Outcomes (6)

  • 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).

    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

    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.

    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).

    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).

    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)

    From the initial assessment to the end intervention after 4 weeks

Secondary Outcomes (4)

  • Penn Spasm Frequency Scale.

    From the initial assessment to the end intervention after 4 weeks

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

    From the initial assessment to the end intervention after 4 weeks.

  • Qualiveen questionnaire (Spanish version)

    From the initial assessment to the end intervention after 4 weeks

  • Neurogenic Bowel Dysfunction (NBD) score (Spanish version)

    From the initial assessment to the end intervention after 4 weeks

Study Arms (2)

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,

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,

Device: Sham transcutaneous spinal cord stimulation on the dorsal region between T11 and T12

Interventions

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.

Active tSCS
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,

Sham tSCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sant Joan de Déu, Palma-Inca

Palma de Mallorca, Balearic Islands, Spain

Location

Related Publications (2)

  • 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.

    PMID: 39885542BACKGROUND

  • Dewsbury 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.

    PMID: 496796BACKGROUND

Study Officials

  • Manuel V Garnacho-Castaño, Professor Catedràtic

    Campus Docent Sant Joan de Déu

    STUDY DIRECTOR

Central Study Contacts

Luis Garcés-Pérez, MD, phD

CONTACT

+34 971 26 58 54luis.garces@sjd.es

Susana Holub-Torres, MD

CONTACT

+34 971 26 58 54susana.holub@sjd.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-blind,sham-controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Medical doctor in Physical and Rehabilitation Medicine

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

ES(1)