Status:
RECRUITING
Transcranial Electrical Stimulation for Treating Chronic Pain in Inflammatory Demyelinating Diseases
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Non-invasive neurostimulation can effectively improve patients' symptoms and has shown good therapeutic efficacy in alleviating the symptoms of IIDDs (Inflammatory Immune-mediated Demyelinating Diseas...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06942611
Start Date
May 3 2025
End Date
July 31 2027
Last Update
July 1 2025
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, China