The Effectiveness of Individualized Transcranial Electrical Stimulation in Improving Cognitive Impairment in Patients With Central Nervous System Inflammatory Demyelinating Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Auditory Verbal Learning Test (AVLT) Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.-
排除标准
- •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.
研究组 & 干预措施
Neuromodulation Group
干预措施: tES (Device)
sham Neuromodulation Group
干预措施: tES (Device)
结局指标
主要结局
Change in Auditory Verbal Learning Test (AVLT) Score
时间窗: Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).
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.
Cognitive Assessments
时间窗: Before treatment, on the last 1 day of treatment, and one month after treatment.
AVLT, Auditory Verbal Learning Test AVLT score is higher, the better.
次要结局
- Change in Symbol Digit Modalities Test (SDMT) Score(Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).)
- Change in EEG Power Spectral Density(Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).)
- Change in Resting-State Functional MRI Network Connectivity(Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).)
- Change in Fractional Anisotropy (FA)(Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).)
- Change in EEG Functional Connectivity(Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).)
- Change in Mean Diffusivity (MD)(Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).)
- Change in Axial Diffusivity (AD)(Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).)
- Change in Radial Diffusivity (RD)(Day 1 (baseline), Day 6 (immediately post-treatment), and Day 36 (30-day post-treatment follow-up).)
- SDMT(Before treatment, on the last 1 day of treatment, and one month after treatment)
- Improvement in EEG Parameters(Before treatment, on the last 1 day of treatment, and one month after treatment)
- Improvement in fMRI Parameters(Before treatment, on the last 1 day of treatment, and one month after treatment)