The Effect of Intradermal Acupuncture on Gallbladder Meridian Points on Cerebral Hemodynamics in Relevant Brain Regions for Major Depressive Disorder Based on fNIRS Technology: Study Protocol of a Prospective, Single-center, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- oxygenated hemoglobin (oxy-Hb)
研究概览
简要总结
Gallbladder meridian(GB) acupoints may play an important role in the treatment of major depressive disorder (MDD). Therefore, this study is designed to focus on the traditional Chinese medicine (TCM) theory of " gallbladder dominating decision ", take the GB as the entry point, and use functional Near-Infrared Spectroscopy(fNIRS) technology to observe the effect of intradermal acupuncture on the cerebral hemodynamic indexes of the prefrontal cortex and bilateral temporal cortex of patients with MDD.
详细描述
This study will include 20 patients with MDD (observation group) and 20 healthy control participants without MDD (control group). fNIRS will be adopted to assess regional oxygen saturation of the blood in the MDD-related cerebral cortex: the prefrontal and bilateral temporal cortex. Based on the results of the fNIRS, to explore cerebral hemodynamic changes in the prefrontal and bilateral temporal cortex in patients with MDD. By observing the changes of hemodynamic characteristics of the prefrontal cortex and bilateral temporal cortex of the observation group and the control group during the course of intradermal acupuncture, explore the immediate response of the hemodynamic characteristics of the prefrontal cortex and bilateral temporal cortex of the observation group to the intervention of the GB acupoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for control group:
- •Healthy control participants who could provide a recent depression screening report, and confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
- •15 ≤ age ≤22 years, male or female;
- •Participants have clear consciousness and could communicate with others normally;
- •Participants could understand the full study protocol and have high adherence. Written informed consent is signed by adult participants themselves，and the minor participants is signed by a guardian;
- •Participants should be right-handed;
- •Inclusion criteria for observation group:
- •MDD patients should meet the diagnostic criteria of the International Classification of Diseases 11th Edition (ICD-11) diagnostic criteria for MDD;
- •15≤ age ≤22, male or female;
- •Participants have clear consciousness and could communicate with others normally;
- •Participants could understand the full study protocol and have high adherence. Written informed consent is signed by adult participants themselves，and the minor participants is signed by a guardian;
- •Not taking antidepressants or antipsychotic drugs for at least 4 weeks before enrollment;
- •Participants should be right-handed;
排除标准
- •Exclusion criteria for control group:
- •Participants with serious primary diseases of cardiovascular diseases, liver diseases, kidney diseases, urinary diseases, and hematological diseases;
- •Participants have an illness, alcohol dependence, or a history of drug abuse;
- •Pregnant or lactating participants;
- •Participants with intellectual disabilities who can't cooperate with the questionnaire survey;
- •Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
- •The test site of participants has scars, hyperpigmentation, red and swollen;
- •Participants are participating in other trials;
- •Exclusion criteria for observation group:
- •Participants with serious primary diseases of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, neurological disease, and other serious primary diseases, and the disease cannot be effectively controlled clinically;
- •MDD caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances;
- •Participants with suicidal tendencies;
- •Pregnant or lactating participants;
- •Participants with intellectual disabilities who cannot cooperate with the questionnaire survey;
- •Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
- •The skin at the test site of participants has scars, hyperpigmentation, red and swollen;
- •Participants are participating in other trials;
研究组 & 干预措施
Observation group
This group will include 20 patients with MDD. Before signal collection, the subject will wear a helmet embedded with numerous near-infrared light sensors, covering the prefrontal region and both temporal lobes. The whole process will be monitored in real time by fNIRS. During needle retention, participants will be asked to keep their eyes closed and quiet throughout the intervention and to avoid physical movement as much as possible.
干预措施: Intradermal acupuncture (Procedure)
Control group
This group will include 20 healthy control participants without MDD. Before signal collection, the subject will wear a helmet embedded with numerous near-infrared light sensors, covering the prefrontal region and both temporal lobes. The whole process will be monitored in real time by fNIRS. During needle retention, participants will be asked to keep their eyes closed and quiet throughout the intervention and to avoid physical movement as much as possible.
干预措施: Intradermal acupuncture (Procedure)
结局指标
主要结局
oxygenated hemoglobin (oxy-Hb)
时间窗: During the whole acupuncture operation
Oxygenated hemoglobin is the combination of hemoglobin plus oxygen.
total hemoglobin (Total-Hb）
时间窗: During the whole acupuncture operation
Total hemoglobin was calculated using the combined concentrations of oxygenated hemoglobin and deoxygenated hemoglobin \[Total-Hb = oxy-Hb + deoxy-Hb\].
deoxygenated hemoglobin (deoxy-Hb)
时间窗: During the whole acupuncture operation
Deoxygenated hemoglobin is the unbound form of hemoglobin with oxygen.
次要结局
未报告次要终点
研究者
Xiaomei Shao
Prof
The Third Affiliated hospital of Zhejiang Chinese Medical University