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| Name | Class |
|---|---|
| Hospital San Juan de Dios, Spain | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tSCS | Experimental | Active tSCS with 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 | Sham Comparator | Sham tSCS, 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, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous spinal cord stimulation on the dorsal region between T11 and T12 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 | 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. | 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). | 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). | 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) | From the initial assessment to the end intervention after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Penn Spasm Frequency Scale. | From 0 (no spasm) to 4 (Spasms occurring more than 10 times per hour) | From the initial assessment to the end intervention after 4 weeks |
| Modified Ashworth Spasticity Scale in knee extensors and plantar flexors. |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Garcés-Pérez, MD, phD | Contact | +34 971 26 58 54 | luis.garces@sjd.es | |
| Susana Holub-Torres, MD | Contact | +34 971 26 58 54 | susana.holub@sjd.es |
| Name | Affiliation | Role |
|---|---|---|
| Manuel V Garnacho-Castaño, Professor Catedrà tic | Campus Docent Sant Joan de Déu | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sant Joan de Déu, Palma-Inca | Palma de Mallorca | Balearic Islands | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39885542 | Background | Comino-Suarez N, Moreno JC, Megia-Garcia A, Del-Ama AJ, Serrano-Munoz D, Avendano-Coy J, Gil-Agudo A, Alcobendas-Maestro M, Lopez-Lopez E, Gomez-Soriano J. Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trial. J Neuroeng Rehabil. 2025 Jan 30;22(1):15. doi: 10.1186/s12984-025-01545-8. | |
| 496796 |
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All the individual participant data (IPD), age, sex, time from injury, level of injury, ethiology of injury, values of primary and secundary outcomes
At the end of the study during 5 years
Researches from other institutions who contact the IP by mail requesting IPD of the study.
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Randomized, double-blind,sham-controlled clinical trial
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|
| Sham transcutaneous spinal cord stimulation on the dorsal region between T11 and T12 | Device | 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, |
|
From 0 (No increase in muscle tone) to 4 (Affected part rigid in flexion or extension).
| 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) | 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 | From the initial assessment to the end intervention after 4 weeks |
| Background |
| Dewsbury DA, Oglesby JM, Shea SL, Connor JL. Inbreeding and copulatory behavior in house mice: a further consideration. Behav Genet. 1979 May;9(3):151-63. doi: 10.1007/BF01071298. |