This Study is Designed to Evaluate the Efficacy of Personalized Alternating Current Stimulation in the Treatment of Emotional Disorders in Patients With Inflammatory Demyelination of the Central Nervous System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- HAMA (Hamilton Anxiety Rating Scale)
研究概览
简要总结
This study is designed to evaluate the efficacy of personalized alternating current stimulation in the treatment of emotional disorders in patients with inflammatory demyelination of the central nervous system.
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 inflammatory demyelinating diseases of the central nervous system, such as neuromyelitis optica spectrum disorders (NMOSD) and multiple sclerosis (MS)
- •Hamilton Anxiety Scale (HAM-A) score > 14
- •Aged between 18 and 65 years, with no gender restrictions
- •Receiving stable doses of immunosuppressive therapy for at least one month
- •Expanded Disability Status Scale (EDSS) score ≤ 6
- •Right-handed
- •Willing to participate and sign informed consent
排除标准
- •Recorded relapse within the past month
- •Recent medication adjustments or treatments involving modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques within the past month
- •Participation in any other clinical study within the past month or currently
- •Presence of cochlear implants, cardiac pacemakers, or implanted stimulators in the brain
- •Impaired skin integrity at the electrode placement site or allergies to electrode gel or adhesives
- •History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections
- •Pregnant or breastfeeding women, or those planning to conceive in the near future
- •Hamilton Depression Scale suicide item score ≥ 3 or comorbid severe mental disorders
- •Presence of severe or unstable organic diseases
- •Poor compliance preventing cooperation with treatment, follow-up, or clinical, EEG, and imaging data collection
- •Any condition deemed unsuitable for study participation by the investigator
结局指标
主要结局
HAMA (Hamilton Anxiety Rating Scale)
时间窗: From enrollment to the end of treatment at 1month
A clinician-administered scale used to assess the severity of a patient's anxiety based on a series of symptoms. Range: 0-56 Higher Scores: Indicate more severe anxiety. Purpose: Used to evaluate the severity of anxiety symptoms in patients, primarily in clinical and research settings.
HADS (Hospital Anxiety and Depression Scale)
时间窗: From enrollment to the end of treatment at 1month
Description: A self-report scale used to identify the levels of anxiety and depression in patients, particularly in a hospital setting. It consists of 14 items, split into two subscales: one for anxiety and one for depression. Range: 0-42 (for each subscale) Higher Scores: Indicate higher levels of anxiety or depression. Purpose: Used for screening and evaluating the severity of anxiety and depression in patients, especially those with physical illnesses.
SPS (Social Phobia Scale)
时间窗: From enrollment to the end of treatment at 1month
A self-report scale used to measure the severity of social anxiety or social phobia. Range: 0-120 Higher Scores: Indicate greater severity of social anxiety. Purpose: Used to assess the intensity of social anxiety and its impact on the individual's daily life.
PSWQ (Penn State Worry Questionnaire)
时间窗: From enrollment to the end of treatment at 1month
A self-report scale used to assess the frequency and intensity of a person's worry. Range: 16-80 Higher Scores: Indicate more frequent and intense worry. Purpose: Primarily used in research and clinical settings to evaluate generalized anxiety and worry tendencies.
次要结局
- EDSS (Expanded Disability Status Scale)(From enrollment to 1 month later)
- FSS (Fatigue Severity Scale)(From enrollment to 1 month later)
- HAMD (Hamilton Depression Rating Scale)(From enrollment to 1 month later)
- MMSE (Mini-Mental State Examination)(From enrollment to 1 month later)
- MoCA (Montreal Cognitive Assessment)(From enrollment to 1 month later)
- SDMT (Symbol Digit Modalities Test)(From enrollment to 1 month later)
- DST (DigiScan Test)(From enrollment to 1 month later)
- BVMT (Brief Visuospatial Memory Test)(From enrollment to 1 month later)
- NRS (Numerical Rating Scale)(From enrollment to 1 month later)
- SF-MPQ (Short-Form McGill Pain Questionnaire)(From enrollment to 1 month later)
- ESS (Epworth Sleepiness Scale)(From enrollment to 1 month later)
- Ashworth Scale(From enrollment to 1 month later)
- SF-36 (Short Form 36 Health Survey)(From enrollment to 1 month later)
- CGI-I (Clinical Global Impression - Improvement)(From enrollment to 1 month later)
- EGI Recording EEG Data and MRI Data(From enrollment to 1 month later)