Synergistic Effect of tDCS and Neuromotor Recruitment on Functional Recovery in Chronic Paraplegia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in Sensory Scores (Light Touch and Pin Prick)
研究概览
简要总结
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).
详细描述
PARTICIPANTS Fifty participants with paraplegia will be recruited from inpatient rehabilitation hospitals. Patients will be treated at Rahma Hospital for Rehabilitation in Tripoli and the Physical Therapy Center of the Faculty of Public Health-I in Hadath.
INCLUSION/EXCLUSION CRITERIA Main inclusion criteria include: age between 18-45 years; diagnosis of chronic spinal cord injury (defined as at least 3 months post-injury); and injury level below T10 with an American Spinal Injury Association Impairment Scale (AIS) classification of A, B, or C. Ethical committee approval will be obtained from the Lebanese University official ethical committee, and informed consent will be obtained from all participants in accordance with the Declaration of Helsinki.
Exclusion criteria include: neuropsychiatric comorbidities; traumatic brain injury (TBI); involvement in any specific program of rehabilitation other than the conventional protocol since injury; and contraindications to tDCS (such as metal in the head or implanted medical devices). Patients with a history of seizure, use of medications containing sodium channel blockers (e.g., carbamazepine), or any substance abuse will be excluded. Patients with severe spasticity (greater than or equal to 3 out of 4 on the Modified Ashworth Scale) will also be excluded.
Prior to the experiment, patients must have received conventional physiotherapy and demonstrated stable lower limb functional scores; performance must not change from the end of conventional therapy until the first baseline measurements.
STUDY DESIGN & ARMS All subjects will be randomly assigned into three groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 ≥
- •Crucial Data Fixes (You must update these fields in the registry UI):
研究组 & 干预措施
Conventional Group
Conventional usual Rehabilitation is administered to a group of patients without any effect on their recovery
干预措施: Conventional Rehabilitation (Other)
NEUROM
participants received the new protocol of a method called NEUROM consisting of 3 phases of treatment : Motor Imagery training, active rehabilitation and functional rehabilitation
干预措施: NEUROM (Other)
NEUROM combined with tDCS
same as the second arm of NEUROM combined with transcranial direct stimulation
干预措施: NEUROM + tDCS (Other)
结局指标
主要结局
Change in Sensory Scores (Light Touch and Pin Prick)
时间窗: Baseline and Week 3
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.
Change in Lower Extremity Motor Score (LEMS) according to ISNCSCI Standards
时间窗: Baseline and Week 3 (End of Intervention)
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.
Change in Assessment of Movement Attempt (AMA) Scores
时间窗: Baseline and Week 3
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.
次要结局
未报告次要终点
研究者
Ahmad Rifai Sarraj
Professor
Lebanese University