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.
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.
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.
Parallel
Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12
DeviceActive 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
DeviceSham 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,
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).
Muscle strength (MRC scale) in knee extensors and plantar flexors
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
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)
This will also be recorded as dichotomous variable (able/unable).
Penn Spasm Frequency Scale.
From 0 (no spasm) to 4 (Spasms occurring more than 10 times per hour)
Modified Ashworth Spasticity Scale in knee extensors and plantar flexors.
From 0 (No increase in muscle tone) to 4 (Affected part rigid in flexion or extension).
Qualiveen questionnaire (Spanish version)
Negative impact on bladder function: from 0 (no impact) to 4 (maximum negative impact)
Neurogenic Bowel Dysfunction (NBD) score (Spanish version)
From 0 to 47 points. Higher score = more severe neurogenic bowel dysfunction
Click on the lead sponsor to view all of their trials.
Fundació Sant Joan de Déu
Lead sponsor
Hospital San Juan de Dios, Spain
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
