The Relationship Between Neuropsychiatric, Radiological Findings and Cortical Inhibition in Patients With Multiple Sclerosis: A Hospital-based Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Motor Evoked Potential (MEP)
研究概览
简要总结
- To investigate the relationship between corticospinal inhibition and clinical, psychological, and cognitive features in MS patients.
- To examine the association between corticospinal inhibition and radiological findings, including MRI lesions and white matter damage
详细描述
Multiple sclerosis (MS) is a chronic immune-mediated disorder of the central nervous system (CNS), characterized by demyelinating white matter lesions and diffuse neurodegeneration. These pathological changes lead to variable and unpredictable clinical presentations and disease progression. Beyond motor and sensory deficits, MS is frequently associated with cognitive and emotional disturbances. Cognitive impairment affects 40-70% of patients, particularly in domains such as attention, processing speed, executive functions, and working memory-significantly impacting daily life and quality of care.
Alexithymia, a condition involving difficulty in identifying and describing emotions, externally oriented thinking, and limited imaginative ability, has been reported in a substantial proportion of patients, especially in progressive forms of the disease. It is frequently associated with sleep disturbances, anxiety, and depression.
Fatigue is one of the most burdensome and common symptoms in MS. It may present at any stage and is defined as a persistent lack of physical or mental energy that interferes with daily function. Fatigue may be classified as primary-linked directly to MS pathophysiology-or secondary, due to comorbid conditions, medication effects, or inactivity. Unlike general fatigue, MS-related fatigue is not relieved by rest and has a distinctly disabling nature.
Depression is another prevalent comorbidity, with lifetime prevalence in MS ranging widely. Its development reflects both the psychological burden of chronic disease and neurobiological mechanisms, such as inflammation and demyelination affecting mood circuits.
Given this wide spectrum of motor, cognitive, and emotional manifestations, comprehensive and multidimensional tools are essential for assessing the functional impact of MS. The Multiple Sclerosis Functional Composite (MSFC) is one such standardized, performance-based assessment. It captures core aspects of MS-related disability across three domains: ambulation (Timed 25-Foot Walk, T25FW), upper limb coordination (9-Hole Peg Test, 9HPT), and cognition (Paced Auditory Serial Addition Test, PASAT-3).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Diagnosis of RRMS based on the 2017 McDonald Criteria.
- •Expanded Disability Status Scale (EDSS) score ≤ 6.
- •On a stable dose of disease-modifying therapy (DMT) for at least 3 months or naeive patients not use DMT before
- •Free of relapses or steroids treatment (at least 3 months after a relapse or corticosteroid therapy)
- •Ability to give informed consent and complete neuropsychological assessments.
排除标准
- •Presence of other neurological or psychiatric disorders (e.g., major depression, bipolar disorder, schizophrenia).
- •History of alcohol or substance abuse.
- •Contraindications to MRI (e.g., pacemakers, metallic implants) and TMS (i.e., history of seizures, presence of ferromagnetic implants in the head area).
- •Medications known to alter the corticospinal excitability.
- •Severe visual deficit, motor weakness, or intellectual impairment (as per the Mini-Mental State Exam score < 24).
结局指标
主要结局
Motor Evoked Potential (MEP)
时间窗: baseline
Obtained using single-pulse transcranial magnetic stimulation over the primary motor cortex. Latency is defined as the time interval from the TMS pulse to the onset of the muscle response. Longer latencies may indicate impaired corticospinal conduction.
Interhemispheric Inhibition (IHI)
时间窗: baseline
The interhemispheric inhibition (IHI) is a parameter reflecting the transcallosal GABA-mediated inhibitory activity. It will be obtained at complete muscle rest using figure-of-eight coils (MC-B70; MagVenture)
Cortical Silent Period (CSP)
时间窗: baseline
Recorded during sustained voluntary muscle contraction using TMS. The silent period is the time during which voluntary electromyographic activity is suppressed following the motor evoked potential. CSP reflects intracortical inhibitory mechanisms.
次要结局
- Toronto Alexithymia Scale (TAS-20)(baseline)
- Fatigue Severity Scale (FSS)(baseline)
研究者
abanoub bassem fikry ramzy
Resident Physician, Department of Neurology and Psychiatry, Assiut University
Assiut University