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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 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,

Study 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.

Eligibility

Primary outcome measure(s)

• Lower Extremity Motor Score (LEMS) according to the International Standards for Neurological Classification of Spinal Cord Injury. — From the initial assessment to the end intervention after 4 weeks
  From 0 (no muscular function) to 25 (normal muscular funcion).
• Muscle strength (MRC scale) in knee extensors and plantar flexors — 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
• Isometric dynamometric force of knee extensors and ankle dorsiflexors in both lower limbs — 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.
• 10-Meter Walk Test (10MWT) — From the initial assessment to the end intervention after 4 weeks
  This will also be recorded as dichotomous variable (able/unable).
• Timed Up and Go (TUG) — From the initial assessment to the end intervention after 4 weeks
  This will also be recorded as dichotomous variable (able/unable).
• Walking Index for Spinal Cord Injury II (WISCI II) — From the initial assessment to the end intervention after 4 weeks
  From 0 (no walking function) to 20 (normal walking function without helping aids)

Trial sites (1)

More Fundació Sant Joan de Déu trials in Spain