Effectiveness of NEUROM and tDCS for Motor Recovery in Chronic Paraplegia

NCT04790149 | Completed DMC

• 1 other identifier: CE-EDST-10-2019
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injury; Neurorehabilitation; Motor and Sensory Recovery; Physical Therapy

Outcome Measures

Primary Outcomes (3)

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

  Motor function is assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). Five key muscles in each lower limb (L2-S1) are graded on a scale of 0 (total paralysis) to 5 (normal active movement). The total score ranges from a minimum of 0 to a maximum of 50. Higher scores indicate better motor function.

  Baseline and Week 3 (End of Intervention)

• Change in Sensory Scores (Light Touch and Pin Prick)

  Sensation is evaluated at 12 key sensory points on both lower limbs according to ISNCSCI standards. Each point is graded as 0 (absent), 1 (impaired), or 2 (normal). Light Touch Total Score Range: 0 to 48. Pin Prick Total Score Range: 0 to 48. Higher scores indicate better sensory function.

  Baseline and Week 3

• Change in Assessment of Movement Attempt (AMA) Scores

  The AMA evaluates the patient's subjective ability to voluntarily attempt movement in the paralyzed limb. It consists of two sub-scales assessed during a structured interview: Intensity of Motor Attempt: Rated on a 6-point scale ranging from 1 (very weak feeling) to 6 (very high intensity). Frequency of Spontaneous Attempt: Rated on a 6-point scale ranging from 1 (very rare) to 6 (very often/daily). Scores are reported individually for each sub-scale. Higher scores indicate better volitional drive and motor intent.

  Baseline and Week 3

Study Arms (3)

Conventional Group

SHAM COMPARATOR

Conventional usual Rehabilitation is administered to a group of patients without any effect on their recovery

Other: Conventional Rehabilitation

NEUROM

EXPERIMENTAL

participants received the new protocol of a method called NEUROM consisting of 3 phases of treatment : Motor Imagery training, active rehabilitation and functional rehabilitation

Other: NEUROM

NEUROM combined with tDCS

EXPERIMENTAL

same as the second arm of NEUROM combined with transcranial direct stimulation

Other: NEUROM + tDCS

Interventions

Conventional Rehabilitation OTHER

Motor Imagery Training combined with Active functional exercises

Also known as: Physical Therapy

Conventional Group

NEUROM + tDCS OTHER

NEUROM combined to tDCS

NEUROM combined with tDCS

NEUROM OTHER

protocol to induce motor recovery

NEUROM

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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):

Sponsors & Collaborators

• Lebanese University: lead

Study Sites (1)

Lebanese University

Beirut, Lebanon

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Physical Therapy Modalities; Transcranial Direct Current Stimulation; NeuroM protein, chicken

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Ahmad Rifai Sarraj, PhD

  Lebanese University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 3 groups receiving parallel different interventions

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 10, 2021
• Study Start: December 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)