Transcranial Electrical Stimulation for Treating Chronic Pain in Inflammatory Demyelinating Diseases

Официальное название

A Study on the Therapeutic Effects of Transcranial Electrical Stimulation Combined on Chronic Pain in Central Nervous System Inflammatory Demyelinating Diseases

Обзор

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.

Вмешательства

• Устройство transcranial electrical stimulation treatment.
  Stimulation targeting the primary motor cortex, current intensity is 1-2mA, duration is 30 minutes, once daily for 5 consecutive days

Первичные конечные точки

• Visual Analog Scale [Срок оценки: From enrollment to the end of treatment at 1 month]

Вторичные конечные точки (12)

• NRS scores [Срок оценки: From enrollment to the end of treatment at 1 month]
• SF-MPQ scores [Срок оценки: From enrollment to the end of treatment at 1 month]
• Modified Ashworth scale [Срок оценки: From enrollment to the end of treatment at 1 month]
• The HAMD (Hamilton Depression Rating Scale) scores [Срок оценки: From enrollment to the end of treatment at 1 month]
• The HAMD (Hamilton Anxiety Rating Scale) scores [Срок оценки: From enrollment to the end of treatment at 1 month]
• Fatigue Severity Scale [Срок оценки: From enrollment to the end of treatment at 1 month]
• MMSE (Mini-Mental State Examination) Score [Срок оценки: From enrollment to the end of treatment at 1 month]
• Epworth Sleepiness Scale scores [Срок оценки: From enrollment to the end of treatment at 1 month]
• Short Form Health Survey-36 Score [Срок оценки: From enrollment to the end of treatment at 1 month]
• EEG features of Absolute Power [Срок оценки: From enrollment to the end of treatment at 1 month]
• EEG features of Absolute Power [Срок оценки: From enrollment to the end of treatment at 1 month]
• Functional Connectivity of EEG data [Срок оценки: From enrollment to the end of treatment at 1 month]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xuanwu Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT06942611 · xw-tES-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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