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

Capital Medical University

Status

Enrolling

Conditions

Multiple Sclerosis

Electric Stimulation

Treatments

Device: Neuroelectrics StarStim 32

Study type

Interventional

Funder types

Other

Identifiers

NCT06968039

xw-tES-04

Details and patient eligibility

About

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.

Enrollment

85 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.