Assessment of Transcranial Alternating Current Stimulation's Clinical Efficacy in Treating Cognitive Impairment of Idiopathic Inflammatory Demyelinating Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Expanded Disability Status Scale, EDSS score
研究概览
简要总结
This study aims to explore the imaging and electrophysiological characteristics of idiopathic inflammatory demyelinating diseases (IIDDs), and their correlation with clinical manifestations. It also evaluates the effectiveness of transcranial electrical stimulation in alleviating clinical symptoms of IIDDs patients, and analyzes the key factors affecting the treatment efficacy. By uncovering the overall and individual characteristics of IIDDs, this study seeks to enhance therapeutic outcomes through personalized neuromodulation programs. The findings will provide a basis for applying non-invasive brain stimulation (NIBS) in IIDDs treatment and offer new ideas for future personalized medicine approaches.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-60 years old.
- •Diagnosis: Patients with neuromyelitis optica spectrum disease, multiple sclerosis and other inflammatory demyelinating diseases of the central nervous system that meet the diagnostic criteria.
- •Medications have been stable for at least three months.
排除标准
- •Recurrence has been recorded in the past 3 months.
- •Have a pacemaker or other metal implant in the body.
- •Impaired skin integrity at the site of electrode placement.
- •Previous organic brain disease such as epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infection.
- •Combined with severe or unstable organic diseases, such as heart, liver and kidney and other organ dysfunction.
- •Pregnant or lactating women, those who are planning to become pregnant in the near future.
- •Patient compliance is poor.
- •In the opinion of the investigator, there is a situation that is not suitable to participate in this study.
研究组 & 干预措施
Neuromodulation group
干预措施: Neuroelectrical modulation group (Device)
Pseudoneuromodulation group
干预措施: Pseudo-neuromodulation group (Device)
结局指标
主要结局
Expanded Disability Status Scale, EDSS score
时间窗: At the 5-day point of treatment and 1 month following the end of treatment
0-10 points, the higher the score, the more serious
Symbol Digit Modalities Test (SDMT) scale
时间窗: At the 5-day point of treatment and 1 month following the end of treatment
0-110 points, the higher the score, the better the cognitive function
Scoring results for tasks 1 and 7 in the Alzheimer disease assessment scale-cog(ADAS-cog)
时间窗: At the 5-day point of treatment and 1 month following the end of treatment
the higher the score, the better the cognitive function
次要结局
- Mini-mental State Examination（MMSE）(At the 5-day point of treatment and 1 month following the end of treatment)
- Montreal-Cognitive Assessment（MoCA）(At the 5-day point of treatment and 1 month following the end of treatment)
- Stroop Color-Word Test score(At the 5-day point of treatment and 1 month following the end of treatment)
- Hamilton Depression Scale，HAMD(At the 5-day point of treatment and 1 month following the end of treatment)
- Hamilton Anxiety Scale，HAMA(At the 5-day point of treatment and 1 month following the end of treatment)
- a subjective questionnaire，adverse effects(Following the first day of treatment，Following the second day of treatment，Following the third day of treatment，Following the fourth day of treatment，Following the fifth day of treatment)