Study on the Mechanism of Pei Tu Ning Feng Tang in Alleviating Tourette Syndrome Via Functional Near-Infrared Spectroscopy (fNIRS) and the DA-MAPK-BDNF Pathway
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional near-infrared spectroscopy (fNIRS) was used to detect the degree of brain function activation.
研究概览
简要总结
Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment. The differences in gut microbiota composition, peripheral blood stress hormones, oxidative stress markers, cytokines, neurotransmitters, and hair cortisol concentrations were observed before and after treatment. Combined with the differences in tic-like behavioral indicators, the therapeutic efficacy of Pei Tu Ning Feng Tang was evaluated. Additionally, TS children underwent two fNIRS examinations before and after treatment to quantitatively describe the activation of brain function by Pei Tu Ning Feng Tang and to investigate its neural mechanisms against tics. Scores were assessed before and after treatment using the Yale Global Tic Severity Scale (YGTSS) and the Traditional Chinese Medicine Syndrome Score Sheet for Pediatric Tourette Syndrome (Spleen Deficiency and Liver Hyperactivity Type) to observe the efficacy of the medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •① Meet the diagnostic criteria for Pediatric Tic Disorder (Spleen Deficiency and Liver Hyperactivity Type) in both traditional Chinese and Western medicine; ② Aged between 4 and 15 years; ③ Guardians provide informed consent, sign the informed consent form, and are able to adhere to the treatment; ④ No visual impairments such as color blindness or color weakness, and no cognitive impairment disorders.
排除标准
- •① Failure to meet the diagnostic criteria for Pediatric Tic Disorder (Spleen Deficiency and Liver Hyperactivity Type) in both traditional Chinese and Western medicine; ② Presence of involuntary movements caused by other diseases, such as Huntington's chorea, hepatolenticular degeneration, myoclonus, epilepsy, etc.; ③ Allergy to any component of the trial medication; ④ Accompanied by severe conditions such as cardiac, hepatic, renal insufficiency, or hematological system disorders.
研究组 & 干预措施
Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment.
The differences in gut microbiota composition, peripheral blood stress hormones, oxidative stress markers, cytokines, neurotransmitters, and hair cortisol concentrations were observed before and after treatment.
干预措施: Tourette Syndrome (TS) children were administered Pei Tu Ning Feng Tang treatment. (Drug)
结局指标
主要结局
Functional near-infrared spectroscopy (fNIRS) was used to detect the degree of brain function activation.
时间窗: From enrollment to the end of the one-month treatment period
Functional near-infrared spectroscopy (fNIRS) was used to obtain real-time changes in oxygenated hemoglobin (Oxy-Hb) and deoxygenated hemoglobin (Deoxy-Hb) in cerebral cortical tissues under specific conditions, indirectly reflecting alterations in cerebral aerobic metabolism during brain activity. Children with Tourette syndrome (TS) underwent two fNIRS examinations before and after treatment to quantitatively describe the degree of brain function activation by Pei Tu Ning Feng Tang and to investigate its neural mechanisms underlying the suppression of tics.Unit: mmol/L
Relative and absolute quantitative analysis of the gut microbiota.
时间窗: From enrollment to the end of the one-month treatment period
Fecal samples collected from children with TS were analyzed to determine the composition and relative abundance of the gut microbiota. Additionally, representative samples were randomly selected for absolute quantitative analysis of the gut microbiota, reflecting the actual abundance of each microbial taxon and the true differences in samples before and after treatment.In relative quantitative analysis, results are expressed as percentages (%). In absolute quantitative analysis, results are reported as 16S rRNA gene copies per gram of sample (copies/g).
Determination of Short-Chain Fatty Acids in Feces
时间窗: From enrollment to the end of the one-month treatment period
In this project, fecal samples were collected from children with TS, and the short-chain fatty acids (SCFAs) in these samples were measured before and after treatment.The commonly used unit for determining SCFAs in feces is micromoles per gram of wet stool weight, i.e., μmol/g wet weight.
Analysis of Stress Hormones
时间窗: From enrollment to the end of the one-month treatment period
Levels of stress hormones in peripheral blood were measured before and after treatment.For example, cortisol is commonly measured in nanomoles per liter (nmol/L).
Analysis of Oxidative Stress Markers
时间窗: From enrollment to the end of the one-month treatment period
Levels of oxidative stress markers, including superoxide dismutase (SOD), nitric oxide (NO), and malondialdehyde (MDA), in peripheral blood were measured separately before and after treatment.The units are as follows: superoxide dismutase (SOD) activity in U/mL, nitric oxide (NO) metabolites in μmol/L, and malondialdehyde (MDA) in nmol/mL.
Analysis of Cytokines
时间窗: From enrollment to the end of the one-month treatment period
Levels of IL-1β, IL-6, and TNF-α in peripheral blood were analyzed before and after treatment.Unit: picogram per milliliter (pg/mL)
Concentration of Neurotransmitters
时间窗: From enrollment to the end of the one-month treatment period
In this project, the concentrations of neurotransmitters including dopamine (DA), glutamate (Glu), and gamma-aminobutyric acid (GABA) in peripheral blood were measured before and after treatment.The units are as follows: dopamine (DA) in pg/mL, glutamate (Glu) in μmol/L, and gamma-aminobutyric acid (GABA) in nmol/L or pg/mL.
次要结局
- Complete the questionnaire survey(From enrollment to the end of the one-month treatment period)
研究者
Dongdong Qin
Doctor
Yunnan University of Chinese Medicine