Status:
RECRUITING
Effectiveness of Personalized Alternating Current Stimulation for Treating Cognitive Impairment in CNS Demyelination Patients
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Multiple Sclerosis
Electric Stimulation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Background: Central nervous system inflammatory demyelinating diseases often lead to significant cognitive impairment, presenting a critical challenge in patient management. Objective: To evaluate th...
Eligibility Criteria
Inclusion
- Patients with Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS), and other Central Nervous System Inflammatory Demyelinating Diseases that meet diagnostic criteria;
- Patients with SDMT scores \<55 or subjective cognitive decline;
- Age between 18 and 65 years, gender unrestricted;
- No relapse or medication changes in the past month;
- EDSS (Expanded Disability Status Scale) score ≤6;
- Right-handed, native Chinese speakers with sufficient educational background to understand the test instructions; -Willing to participate and have signed informed consent.-
Exclusion
- Relapse record within the past month;
- Medication adjustment within the past month or having undergone modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques;
- Participating in any other clinical research within 1 month prior to enrollment or currently;
- Presence of cochlear hearing aids, cardiac pacemakers, or implanted brain stimulation devices;
- Skin integrity damage at electrode placement sites, or allergy to electrode gel or adhesives;
- History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections;
- Pregnant or lactating women, or those planning pregnancy in the near future;
- Scoring ≥3 on item 3 (suicide item) of the HDRS-17 or concurrent severe mental illness;
- Concurrent severe or unstable organic diseases;
- Unable to cooperate with treatment, follow-up, or clinical, EEG, and imaging data collection due to poor patient compliance;
- Other situations deemed inappropriate for study participation by the researchers.
Key Trial Info
Start Date :
December 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT06968039
Start Date
December 31 2024
End Date
October 1 2027
Last Update
May 13 2025
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 10000