Status:
RECRUITING
Effectiveness of Personalized Alternating Current Stimulation for Treating Emotional Disorders in CNS Demyelination Patients
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
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 nervo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06933537
Start Date
December 29 2024
End Date
October 1 2027
Last Update
April 18 2025
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000