Central nervous system inflammatory demyelination patients
Conditions
Interventions
Sham neuromodulation group:Sham transcranial electrical stimulation
Neuromodulation group:Individualized transcranial electrical stimulation treatment
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The central nervous system inflammatory demyelinating diseases that meet the diagnostic criteria, such as neuromyelitis optica spectrum disorders and multiple sclerosis. 2. Hamilton Anxiety Rating Scale score > 14. 3. Age between 18 and 65 years old, regardless of gender. 4. Stable dose of immunosuppressive therapy within the past 1 month. 5. EDSS score <= 6. 6. Right-handed. 7. Consent to participate and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. History of relapse within the past 1 month. 2. History of medication adjustment or undergoing modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques within the past 1 month. 3. Participation in any other clinical trials within 1 month prior to enrollment or currently. 4. Presence of cochlear implants, cardiac pacemakers, or implanted brain stimulators. 5. Skin integrity impairment at the electrode placement site, or allergy to electrode gel or adhesive. 6. History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections or other organic brain diseases. 7. Pregnant or breastfeeding women, or those planning pregnancy recently. 8. Hamilton Depression Rating Scale suicide item score >=3 or concurrent severe psychiatric disorders. 9. Concurrent severe or unstable organic diseases. 10. Unable to cooperate with treatment, follow-up, or clinical, EEG, and imaging data collection due to poor patient compliance. 11. Investigator considers the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMA Score Difference; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety indicators;Fatigue Severity Scale (FSS);Electrophysiological indicators;Hamilton Depression Rating Scale; | — |
Countries
China
Contacts
Public ContactJunwei Hao
Xuanwu Hospital Capital Medical University
Outcome results
None listed