Effectiveness of NEUROM and tDCS for Motor Recovery in Chronic Paraplegia (NCT04790149) | Clinical Trial Compass
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 range
16 Years – 45 Years
Sex
ALL
See this in plain English?
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):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Lower Extremity Motor Score (LEMS) according to ISNCSCI Standards
Timeframe: Baseline and Week 3 (End of Intervention)
2
Change in Sensory Scores (Light Touch and Pin Prick)
Timeframe: Baseline and Week 3
3
Change in Assessment of Movement Attempt (AMA) Scores