Incomplete Spinal Cord Injury (SCI)
Conditions
Keywords
Incomplete Spinal Cord Injury, Transcutaneous Electrical Spinal Cord Stimulation, Cycling
Brief 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.
Interventions
DEVICETranscutaneous 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.
DEVICESham 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,
Sponsors
Fundació Sant Joan de Déu
Hospital San Juan de Dios, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized, double-blind,sham-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. .-Spasticity grade less than 3 on the Modified Ashworth Scale. * Signed informed consent.
Exclusion criteria
* 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. * Fixed joint contractures limiting range of motion. * Significantly reduced bone density (osteoporosis). * Unhealed fractures. * Pregnancy. * Active tumor process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Penn Spasm Frequency Scale. | From the initial assessment to the end intervention after 4 weeks | 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 the initial assessment to the end intervention after 4 weeks. | From 0 (No increase in muscle tone) to 4 (Affected part rigid in flexion or extension). |
| Qualiveen questionnaire (Spanish version) | From the initial assessment to the end intervention after 4 weeks | Negative impact on bladder function: from 0 (no impact) to 4 (maximum negative impact) |
| Neurogenic Bowel Dysfunction (NBD) score (Spanish version) | From the initial assessment to the end intervention after 4 weeks | From 0 to 47 points. Higher score = more severe neurogenic bowel dysfunction |
Countries
Spain
Contacts
CONTACTLuis Garcés-Pérez, MD, phD
CONTACTSusana Holub-Torres, MD
STUDY_DIRECTORManuel V Garnacho-Castaño, Professor Catedràtic
Campus Docent Sant Joan de Déu
Outcome results
None listed