Effects of Transcranial Electrical Stimulation on Cognitive Impairment in CNS Inflammatory Demyelinating Diseases

Xuanwu Hospital, Beijing40 enrolled

Overview

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 tES intervention, measuring changes in cognitive domains including memory, attention, executive function, and processing speed. Anticipated Results: the investigators 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria:、 1. Patients with Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS), and other Central Nervous System Inflammatory Demyelinating Diseases that meet diagnostic criteria; 2. Patients with SDMT scores \<55 or subjective cognitive decline; 3. Age between 18 and 65 years, gender unrestricted; 4. Hamilton Anxiety and Depression Scale scores \<7 points for both scales; 5. No relapse or medication changes in the past month; 6. EDSS (Expanded Disability Status Scale) score ≤6; 7. Right-handed, native Chinese speakers with sufficient educational background to understand the test instructions; 8. Willing to participate and have signed informed consent.- Exclusion Criteria: 1. Relapse record within the past month; 2. Medication adjustment within the past month or having undergone modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques; 3. Participating in any other clinical research within 1 month prior to enrollment or currently; 4. Presence of cochlear hearing aids, cardiac pacemakers, or implanted brain stimulation devices; 5. Skin integrity damage at electrode placement sites, or allergy to electrode gel or adhesives; 6. History of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections; 7. Pregnant or lactating women, or those planning pregnancy in the near future; 8. Scoring ≥3 on item 3 (suicide item) of the HDRS-17 or concurrent severe mental illness; 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. Other situations deemed inappropriate for study participation by the researchers.

Outcomes

Primary Outcomes

Change in Auditory Verbal Learning Test (AVLT) Score

The Auditory Verbal Learning Test (AVLT) evaluates verbal learning and memory performance. The AVLT consists of multiple components, including immediate recall, delayed recall, and recognition memory. The immediate recall score is obtained from three consecutive learning trials and ranges from 0 to 36. The 5-minute delayed recall score ranges from 0 to 12, and the 20-minute delayed recall score ranges from 0 to 12. The recognition score ranges from 0 to 24 after interference trials. Higher scores indicate better cognitive performance.