Clinical trial Recruiting at 1 site Interventional Ages 18 to 75

Non-invasive spinal stimulation combined with gait training to improve walking after incomplete spinal cord injury

Official title: Design of tSCS Strategies to Promote Neural Plasticity and Improve Functional Outcomes During Rehabilitation of Locomotion

Run by Institut Guttmann · NCT07289191 · Data updated 2026-11-12

This tests whether adding non-invasive spinal cord stimulation to gait training helps adults with chronic incomplete spinal cord injury walk better and have less spasticity.

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment10 (estimated)
SponsorInstitut Guttmann
Academic / other
Locations1 site (Badalona, Barcelona)
StatusRecruiting
StartedJanuary 1, 2021
Main results expectedSeptember 11, 2024
Study endsFebruary 1, 2026
Registry record updatedDecember 17, 2025
Trial IDNCT07289191 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults over 18 with a stable incomplete cervical or thoracic spinal cord injury (AIS-D), at least 6 months post-injury, who can walk at least 6 meters with or without assistance are eligible.

Probably not a fit

Patients with unstable medical conditions, severe spasticity (MAS ≥3), peripheral nerve involvement, skin ulcers at electrode sites, or intolerance to tSCS are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants complete gait rehabilitation sessions with and without transcutaneous spinal cord stimulation (tSCS) to identify the most effective stimulation settings. Clinical outcomes include neurological level and motor/sensory function using ASIA/ISNCSCI, walking measures such as the 10-meter walk test and WISCI II, and spasticity via the Modified Ashworth Scale. Optional neurophysiological tests (F- and H-waves, TMS-evoked MEPs, and surface EMG) will probe spinal excitability and corticospinal conduction to explore underlying mechanisms. The protocol compares functional and physiological changes after gait training with tSCS versus gait training alone to determine whether tSCS facilitates lower-limb strength and gait recovery.

Why it matters

Potential benefit: If successful, this approach could reduce spasticity and improve walking speed, strength, and independence for people with incomplete spinal cord injury.

How similar studies have gone: Prior research using non-invasive spinal stimulation has shown promising improvements in motor function and gait in some people with SCI, but optimal stimulation parameters and reproducibility across centers remain under study.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Male or female more than 18 years old;
* With a stable traumatic o nor traumatic incomplete motor cervical or thoracic SCI;
* Time since SCI more than 6 months;
* American Spinal Injury Association Impairment Scale (AIS)-D who could realize gait at least 6 meters with or without technical help;
* Capacity for compression the nature of the study and signed informed consent.

Exclusion Criteria:

* Unstable medical condition (cancer, acute infections, etc.);
* Severe spasticity (≥ 3 score on the Modified Ashworth scale (MAS)),
* Peripheral nerve affectation;
* Ulcers on the electrode applied area;
* Intolerance of tSCS.

Where it's running

  • Institut Guttmann
    Badalona, Barcelona, Spain
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.