The Effect of Trans-cranial Direct Current Stimulation and Cognitive Rehabilitation on Cognitive Functions and Neuronal Plasticity inPatients With Multiple Sclerosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in verbal memory performance measured by California Verbal Learning Test-II (CVLT-II)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether transcranial direct current stimulation (tDCS) and cognitive rehabilitation can improve cognitive functions and neuronal plasticity in patients with multiple sclerosis (MS). The participant population consists of MS patients (both sexes, adults), who commonly experience cognitive impairment in addition to physical and psychological symptoms.
The main questions it aims to answer are:
Does tDCS applied over the left dorsolateral prefrontal cortex improve cognitive abilities in MS patients?
Does the combination of tDCS and cognitive rehabilitation enhance neuroplasticity, as measured by DTI, BDNF levels, and acetylcholinesterase activity?
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 50 years.
- •Diagnosed with relapsing-remitting multiple sclerosis (RRMS).
- •Mild disability, defined as EDSS <
- •Patients who attended the neurology clinic and are willing to participate.
排除标准
- •Presence of psychiatric disorders requiring treatment with neuroleptics.
- •History of seizures.
- •Left-handed individuals.
- •Recent MS relapse requiring steroid treatment.
- •Pregnant women.
- •History of brain surgery or presence of intracranial clips.
研究组 & 干预措施
tDCS
A 30-minute tDCS session with the cathode placed over the left dorsolateral prefrontal cortex (DLPFC)
干预措施: tDCS (Device)
tDCS+Cognitive training
A 30-minute tDCS session with the cathode over the left DLPFC combined with computer-based cognitive rehabilitation training
干预措施: tDCS (Device)
tDCS+Cognitive training
A 30-minute tDCS session with the cathode over the left DLPFC combined with computer-based cognitive rehabilitation training
干预措施: Cognitive Rehabilitation (Device)
Sham tDCS
Sham stimulation applied over the left DLPFC, mimicking the sensation of tDCS without delivering active current
干预措施: Sham tDCS (Device)
结局指标
主要结局
Change in verbal memory performance measured by California Verbal Learning Test-II (CVLT-II)
时间窗: Baseline and immediately after 10 intervention sessions
The CVLT-II assesses verbal learning and memory through a word recall task. Scores include total recall, short-delay recall, and long-delay recall. Assessments will be conducted at baseline and after 4 weeks of intervention.
Change in attention performance measured by Integrated Visual and Auditory Continuous Performance Test (IVA-2)
时间窗: Baseline and immediately after 10 intervention sessions
The IVA-2 evaluates visual and auditory attention and response control. Scores include full-scale attention quotient, visual attention, auditory attention, and response control. Assessments will be conducted at baseline and post-intervention to assess changes in attention performance
Change in visuospatial memory performance measured by Rey-Osterrieth Complex Figure Test
时间窗: Baseline and immediately after 10 intervention sessions
The Rey-Osterrieth Complex Figure Test evaluates visuospatial constructional ability and memory. Participants copy a complex figure (copy trial) and then reproduce it from memory immediately and after a delay. Assessments will be conducted at baseline and after completion of the tDCS intervention to assess changes in visuospatial memory performance.
Change in serum BDNF levels (ng/mL)
时间窗: Baseline and immediately after 10 intervention sessions
Serum brain-derived neurotrophic factor (BDNF) concentration will be measured using an enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected at baseline and after completion of the tDCS intervention. Changes in BDNF levels will be analyzed to assess neuroplasticity.
Change in white matter integrity measured by Diffusion Tensor Imaging (DTI)
时间窗: Baseline and immediately after 10 intervention sessions
White matter integrity will be assessed using DTI MRI scans. Primary metrics include Fractional Anisotropy (FA) and Mean Diffusivity (MD) in predefined brain regions. Scans will be performed at baseline and after completion of the tDCS intervention to evaluate neuroplasticity-related changes
Change in acetylcholinesterase (AChE) activity in blood (U/mL)
时间窗: Baseline and immediately after 10 intervention sessions
Acetylcholinesterase activity will be measured in blood samples using a spectrophotometric enzymatic assay. Samples will be collected at baseline and after completion of the tDCS intervention. Changes in AChE activity will be analyzed to assess cholinergic system function and neuroplasticity.
次要结局
未报告次要终点
研究者
Mehrdad Roozbeh
Assistant Professor of Neurology
Shahid Beheshti University of Medical Sciences