Non-invasive spinal stimulation combined with gait training to improve walking after incomplete spinal cord injury
Design of tSCS Strategies to Promote Neural Plasticity and Improve Functional Outcomes During Rehabilitation of Locomotion
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Institut Guttmann Academic / other |
| Locations | 1 site (Badalona, Barcelona) |
| Trial ID | NCT07289191 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Badalona, Barcelona
- Institut Guttmann — Badalona, Barcelona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.