NCT07445685

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Incomplete Spinal Cord Injury (SCI)

Interventions

Type	Name	Description
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.
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,

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-03-03
• Last updated: 2026-03-04

Locations

1 site across 1 country: Spain