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

Official title

Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury: a Randomized, Double-blind Study.

Overview

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

• Device 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.
• Device 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,

Primary outcome measures

• Lower Extremity Motor Score (LEMS) according to the International Standards for Neurological Classification of Spinal Cord Injury. [Time frame: From the initial assessment to the end intervention after 4 weeks]
• Muscle strength (MRC scale) in knee extensors and plantar flexors [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 [Time frame: From the initial assessment to the end intervention after 4 weeks]
• 10-Meter Walk Test (10MWT) [Time frame: From the initial assessment to the end intervention after 4 weeks]
• Timed Up and Go (TUG) [Time frame: From the initial assessment to the end intervention after 4 weeks]
• Walking Index for Spinal Cord Injury II (WISCI II) [Time frame: From the initial assessment to the end intervention after 4 weeks]

Secondary outcome measures (4)

• Penn Spasm Frequency Scale. [Time frame: From the initial assessment to the end intervention after 4 weeks]
• Modified Ashworth Spasticity Scale in knee extensors and plantar flexors. [Time frame: From the initial assessment to the end intervention after 4 weeks.]
• Qualiveen questionnaire (Spanish version) [Time frame: From the initial assessment to the end intervention after 4 weeks]
• Neurogenic Bowel Dysfunction (NBD) score (Spanish version) [Time frame: From the initial assessment to the end intervention after 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Sant Joan de Déu, Palma-Inca — Palma de Mallorca

Publications

• 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 Neuro PMID 39885542
• 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. PMID 496796

Identifiers

NCT: NCT07445685 · IB 5797/25 PS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗