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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
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 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,
Hospital Sant Joan de Déu, Palma-Inca
Palma de Mallorca, Balearic Islands, Spain
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).
Time frame: From the initial assessment to the end intervention after 4 weeks
Muscle strength (MRC scale) in knee extensors and plantar flexors
From 0 (no muscle function) to 5 (normal muscle function) for each muscle groups
Time frame: From the initial assessment to the end intervention after 4 weeks
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.
Time frame: From the initial assessment to the end intervention after 4 weeks
10-Meter Walk Test (10MWT)
This will also be recorded as dichotomous variable (able/unable).
Time frame: From the initial assessment to the end intervention after 4 weeks
Timed Up and Go (TUG)
This will also be recorded as dichotomous variable (able/unable).
Time frame: From the initial assessment to the end intervention after 4 weeks
Walking Index for Spinal Cord Injury II (WISCI II)
From 0 (no walking function) to 20 (normal walking function without helping aids)
Time frame: From the initial assessment to the end intervention after 4 weeks
Penn Spasm Frequency Scale.
From 0 (no spasm) to 4 (Spasms occurring more than 10 times per hour)
Time frame: From the initial assessment to the end intervention after 4 weeks
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).
Time frame: From the initial assessment to the end intervention after 4 weeks.
Qualiveen questionnaire (Spanish version)
Negative impact on bladder function: from 0 (no impact) to 4 (maximum negative impact)
Time frame: From the initial assessment to the end intervention after 4 weeks
Neurogenic Bowel Dysfunction (NBD) score (Spanish version)
From 0 to 47 points. Higher score = more severe neurogenic bowel dysfunction
Time frame: From the initial assessment to the end intervention after 4 weeks
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