Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change in Tinnitus Severity Grading
研究概览
简要总结
This trial aims to use machine learning to analyze fNIRS imaging data of specific brain regions of tinnitus patients, thereby constructing a predictive model of the clinical efficacy of acupuncture for SNT.
详细描述
This study will recruit 500 subjects with tinnitus. Functional near-infrared spectroscopy (fNIRS) will be employed to examine specific brain regions, and the corresponding fNIRS imaging data from all detection channels will be extracted. Subsequently, the subjects will undergo a course of acupuncture treatment. Based on the recovery status of tinnitus at the conclusion of the acupuncture course, all subjects will be categorized into a "good prognosis group" and a "poor prognosis group" according to relevant efficacy criteria. The entire dataset will then be randomly divided into a training set (70%) and a test set (30%) following a 7:3 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Bilateral tinnitus that meets the diagnostic criteria for chronic subjective tinnitus.
- •Male and female, aged between 18 and 60 years.
- •Right-handed subjects who are able to comply with the study protocol and sign written informed consent.
- •Not participating in other clinical trials concurrently.
排除标准
- •Participants with objective tinnitus.
- •Participants have nervous system diseases or neuropsychiatric diseases that can significantly affect brain blood oxygen metabolism assessed by fNIRS.
- •Participants with severe cardiovascular and cerebrovascular diseases, malignant liver and kidney diseases, and other serious diseases.
- •Participants have any contraindications for acupuncture (such as a bleeding tendency).
- •Pregnant or lactating women.
- •Participants have received tinnitus treatment with drugs or other therapies in the last four weeks.
研究组 & 干预措施
The acupuncture group
Subjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks.
干预措施: acupuncture (Procedure)
结局指标
主要结局
Change in Tinnitus Severity Grading
时间窗: at baseline (pre-treatment), after 4-week treatment
Tinnitus Severity Grading is based on relevant expert consensus.
Change in hemoglobin signals
时间窗: at baseline (pre-treatment), after 4-week treatment
Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).
Change in resting-state functional connectivity (RSFC)
时间窗: at baseline (pre-treatment), after 4-week treatment
RSFC will be measured by functional near-infrared spectroscopy (fNIRS).
次要结局
- Change in Tinnitus Handicap Inventory score(at baseline (pre-treatment), after 4-week treatment)
- Change in average pure-tone threshold(at baseline (pre-treatment), after 4-week treatment)
研究者
Hantong Hu
M.D.
The Third Affiliated hospital of Zhejiang Chinese Medical University