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Effectiveness of Personalized Alternating Current Stimulation for Treating Cognitive Impairment in CNS Demyelination Patients

NCT06968039

RecruitingNA

Sponsor: Xuanwu Hospital, Beijing

Conditions: Multiple Sclerosis, Electric Stimulation

Interventions: Neuroelectrics StarStim 32, Neuroelectrics StarStim 32

Countries: China

Background: Central nervous system inflammatory demyelinating diseases often lead to significant cognitive impairment, presenting a critical challenge in patient management. Objective: To evaluate the effectiveness of individualized transcranial electrical stimulation (tES) in improving cognitive function among patients with inflammatory demyelinating disorders. Methods: This study will assess cognitive performance through standardized neuropsychological assessments before and after individualized a one-time tES intervention, measuring changes in cognitive domains including working memory, attention, executive function, and processing speed. Anticipated Results: We hypothesize that personalized transcranial electrical stimulation will demonstrate significant improvements in cognitive performance, potentially offering a non-invasive therapeutic approach for managing cognitive decline in central nervous system inflammatory demyelinating diseases. Significance: This research may provide novel insights into neuromodulation strategies for cognitive rehabilitation in patients with complex neurological conditions.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Locations (1)

Beijing, Beijing Municipality, China