CompletedNot Applicable

Effectiveness of NEUROM and tDCS for Motor Recovery in Chronic Paraplegia

Lebanon56 participantsStarted 2022-12-01

Plain-language summary

Traumatic Spinal Cord Injury (TSCI) is a catastrophic, unexpected, and devastating event that can occur along the spinal column (cervical, thoracic, and lumbar). Traditional views describe the spinal cord as a protected bundle of nerves connecting the brain to the body. TSCI often results in life-threatening conditions including varying degrees of motor paralysis, sensory loss, and impairment of bowel, bladder, sexual, and other physiologic functions. In this study, the investigators propose a new experimental rehabilitative protocol for TSCI patients called the Neural Motor Recruitment Method (NEUROM). This method is based on histological and functional reorganization models following TSCI, Motor Imagery (MI) concepts, and targeted sensory inputs related to motor recovery. It is hypothesized that this new method can enhance sparing-induced plasticity and increase motor and sensory recovery in SCI patients, especially when combined with Transcranial Direct Current Stimulation (tDCS).

Who can participate

Age range16 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Age: Between 16 and 45 years. * Diagnosis: Chronic spinal cord injury (at least 3 months post-injury). * Level of Injury: Lower dorsal (below T10) or lumbar. * Classification: American Spinal Injury Association Impairment Scale (AIS) grade A, B, or C. * Signed Informed Consent. Exclusion Criteria * Comorbidities: Neuropsychiatric comorbidities or Traumatic Brain Injury (TBI). * Concurrent Treatment: Involvement in any specific rehabilitation program other than the conventional protocol since injury. * tDCS Contraindications: Presence of metal in the head or implanted medical devices (e.g., pacemaker, cochlear implant). * Seizure History: Any history of epilepsy or seizures. * Medications: Current use of medications containing sodium channel blockers (e.g., carbamazepine) or history of substance abuse. * Spasticity: Severe spasticity defined as a Modified Ashworth Scale score ≥ 3. Crucial Data Fixes (You must update these fields in the registry UI):

What they're measuring

Change in Lower Extremity Motor Score (LEMS) according to ISNCSCI Standards

Timeframe: Baseline and Week 3 (End of Intervention)

Change in Sensory Scores (Light Touch and Pin Prick)

Timeframe: Baseline and Week 3

Change in Assessment of Movement Attempt (AMA) Scores

Timeframe: Baseline and Week 3

Trial details

NCT IDNCT04790149

SponsorLebanese University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01