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

Официальное название

This Study is Designed to Evaluate the Efficacy of Personalized Alternating Current Stimulation in the Treatment of Working Memory in Patients With Inflammatory Demyelination of the Central Nervous System

Обзор

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.

Вмешательства

• Устройство Neuroelectrics StarStim 32
  Using the advanced Neuroelectrics StarStim 32 device from Spain, individualized imaging modeling systems are employed to precisely target the frontal and parietal cortex. Personalized EEG-guided electrical stimulation protocols are selected. The stimulation parameters are as follows: a current intensity of 2 mA, a duration of 21 minutes per session for one time with EEG monitoring conducted before and after electrical stimulation.
• Устройство Neuroelectrics StarStim 32
  Sham stimulation is performed using the same device and procedures as the neuromodulation group. The stimulator automatically shuts off after 30 seconds, while maintaining the device's connection. This design creates an initial sensation similar to actual stimulation while preserving the double-blind nature of the study.

Первичные конечные точки

• Working Memory Training-Related Scores [Срок оценки: An hour before and after interventions]
• SDMT (Symbol Digit Modalities Test) [Срок оценки: An hour before and after interventions.]

Вторичные конечные точки (4)

• AVLT (Auditory Verbal Learning Test) [Срок оценки: Before interventions]
• Digit Span Test [Срок оценки: An hour before interventions]
• BVMTR (Brief Visual Memory Test-Revised) [Срок оценки: An hour before and after interventions.]
• STROOP (Stroop Color and Word Test) [Срок оценки: An hour before and after interventions.]

Критерии участия

Критерии включения

• 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.-

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xuanwu Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT06968039 · xw-tES-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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