A Study on the Therapeutic Effects of Transcranial Electrical Stimulation Combined on Chronic Pain in Central Nervous System Inflammatory Demyelinating Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
Non-invasive neurostimulation can effectively improve patients' symptoms and has shown good therapeutic efficacy in alleviating the symptoms of IIDDs (Inflammatory Immune-mediated Demyelinating Diseases). However, some patients have not achieved the desired results, which may be due to individual differences in neural responsiveness . Therefore, this study aims to assess the therapeutic effect of transcranial electrical stimulation on improving symptoms such as painful spasm in IIDDs patients, by considering both the overall characteristics of IIDDs disease symptoms and individual differences in patients. The study will explore the imaging characteristics, electrophysiological features of the disease symptoms, and their relationship with clinical manifestations, while analyzing the key factors that influence treatment efficacy.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with neuromyelitis optica spectrum disorder, multiple sclerosis, or other central nervous system inflammatory demyelinating diseases that meet the diagnostic criteria;
- •Numeric Rating Scale (NRS) pain score ≥4;
- •Age between 18 and 65 years, regardless of gender;
- •Stable dose of immunosuppressive therapy for at least one month;
- •EDSS score ≤6;
- •Right-handed;
- •Agree to participate and sign the informed consent form.
排除标准
- •A history of relapse within the past month;
- •Recent medication adjustments or treatment with modified electroconvulsive therapy, transcranial magnetic stimulation, or other neurostimulation techniques within the past month;
- •Participation in any other clinical trial within the past month or currently participating in another clinical trial;
- •Presence of cochlear implants, pacemakers, or implanted stimulators in the brain;
- •Skin integrity at the electrode placement site is compromised, or allergy to electrode gel or adhesive;
- •A history of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections;
- •Pregnant or breastfeeding women, or those planning to become pregnant in the near future;
- •A score of ≥3 on item 3 (suicide item) of the HDRS-17, or a history of severe psychiatric disorders;
- •Presence of severe or unstable organic diseases;
- •Poor patient compliance preventing cooperation with treatment, follow-up, or clinical, EEG, and imaging data collection;
- •Any other situation deemed unsuitable for participation in the study by the investigator.
结局指标
主要结局
Visual Analog Scale
时间窗: From enrollment to the end of treatment at 1 month
VAS Score (Visual Analog Scale) is a commonly used tool to assess pain intensity. It usually consists of a line marked with "no pain" (0 points) and "worst possible pain" (such as 0-100 points). The patient marks their level of pain on the line to provide a score. The advantage of the VAS is its simplicity, clarity, and ease of use for patients.
次要结局
- NRS scores(From enrollment to the end of treatment at 1 month)
- SF-MPQ scores(From enrollment to the end of treatment at 1 month)
- Modified Ashworth scale(From enrollment to the end of treatment at 1 month)
- The HAMD (Hamilton Depression Rating Scale) scores(From enrollment to the end of treatment at 1 month)
- The HAMD (Hamilton Anxiety Rating Scale) scores(From enrollment to the end of treatment at 1 month)
- Fatigue Severity Scale(From enrollment to the end of treatment at 1 month)
- MMSE (Mini-Mental State Examination) Score(From enrollment to the end of treatment at 1 month)
- Epworth Sleepiness Scale scores(From enrollment to the end of treatment at 1 month)
- Short Form Health Survey-36 Score(From enrollment to the end of treatment at 1 month)
- Functional Connectivity of EEG data(From enrollment to the end of treatment at 1 month)
- Microstate Analysis of EEG data(From enrollment to the end of treatment at 1 month)
- Nonlinear Dynamics of EEG data(From enrollment to the end of treatment at 1 month)
- Graph theory metrics of EEG data(From enrollment to the end of treatment at 1 month)
- Structural measures from T1-weighted MRI(From enrollment to the end of treatment at 1 month)
- Functional measures of resting-state fMRI(From enrollment to the end of treatment at 1 month)
- The Pittsburgh Sleep Quality Index (PSQI)(From enrollment to the end of treatment at 1 month)
- SF-MPQ scores(From enrollment to the end of treatment at 1 month)
- NRS scores(From enrollment to the end of treatment at 1 month)
- Modified Ashworth scale(From enrollment to the end of treatment at 1 month)
- The HAMD (Hamilton Depression Rating Scale) scores(From enrollment to the end of treatment at 1 month)
- Microstate Analysis of EEG data(From enrollment to the end of treatment at 1 month)
- Nonlinear Dynamics of EEG data(From enrollment to the end of treatment at 1 month)
- Graph theory metrics of EEG data(From enrollment to the end of treatment at 1 month)
- Structural measures from T1-weighted MRI(From enrollment to the end of treatment at 1 month)
- Functional measures of resting-state fMRI(From enrollment to the end of treatment at 1 month)
- EEG features of Absolute Power(From enrollment to the end of treatment at 1 month)