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

Официальное название

The Effectiveness of Individualized Transcranial Electrical Stimulation in Improving Cognitive Impairment in Patients With Central Nervous System Inflammatory Demyelinating Diseases

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 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.

Вмешательства

• Устройство tES
  his study employs a randomized controlled trial (RCT) design, randomly dividing eligible participants into a neuromodulation group and a sham neuromodulation group. Neuromodulation Group: Receive individualized transcranial electrical stimulation (tES) treatment Combined with cognitive training Stimulation parameters: Total current: approximately 2mA Duration: 21 minutes Electroencephalogram (EEG) and functional MRI (fMRI) monitoring before and after electrical stimulation
• Устройство tES
  Use the same device and procedure as the neuromodulation group Stimulation device automatically turns off after 30 seconds Maintain device connection Design creates similar initial sensations to actual stimulation Maintains the double-blind nature of the study

Первичные конечные точки

• Cognitive Assessments [Срок оценки: Before treatment, on the last 1 day of treatment, and one month after treatment.]

Вторичные конечные точки (3)

• SDMT [Срок оценки: Before treatment, on the last 1 day of treatment, and one month after treatment]
• Improvement in EEG Parameters [Срок оценки: Before treatment, on the last 1 day of treatment, and one month after treatment]
• Improvement in fMRI Parameters [Срок оценки: Before treatment, on the last 1 day of treatment, and one month after treatment]

Критерии участия

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;
• Hamilton Anxiety and Depression Scale scores <7 points for both scales;
• 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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xuanwu Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07029386 · xw-tES-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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