Activation on Left Dorsolateral Prefrontal Cortex LDPC With Different Acupoint-Combinations for Depression: An fNIRS Study
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change of Brain activation hemodynamic signals in 6 acupuncture sessions (concentration level of Oxygenated Hemoglobin (O2Hb) over the left dorsolateral prefrontal cortex (DLPFC)
研究概览
简要总结
This is a randomized, open-labelled study to study the effect of the different acupoints combination under TCM treatment principles by fNIRS.
The investigator aim to recruited 36 depression subjects and go through 6 acupuncture treatment sessions in 3 weeks. They will be divided into 2 groups by randomization. (Group A n=18, Group B n=18) The participants will receive 2 acupuncture session per week for 3 consecutively weeks. In each treatment session, all subjects in both groups will receive the same amount of needle insertion ( total 14 needles) , all needles will be retained for 30 minutes. The whole treatment will last for around 45 minutes. No sedation will be conducted.
Subjects in Group A will receive 14 needles based on the TCM theory "Soothing liver-qi stagnation", all needles will be retained for 30 minutes. Acupoint combination: Taichong 太衝 (LR 3), Ligou 蠡沟 (LR 5), Zhongdu 中都(LR6), Xiguan 膝關 (LR 7), Ququan 曲泉 (LR 8), Zhangmen 章門(LR13), Qimen 期門 (LR14).
Subjects in Group B will receive 14 needles based on the TCM theory "Soothing liver-qi stagnation" and "Tonifying the heart and the spleen"and "Invigorating the Yang Qi", all needles will be retained for 30 minutes. Acupoint combination: Taichong 太衝 (LR 3), , Sanyinjiao 三陰交 (SP 6), Xuanzhong 懸鐘 (GB 39), Shenmen 神門 (HT 7), Zusanli 足三里(ST 36), Baihui 百會(DU 20), Shenting 神庭(DU24), Qihai 氣海(RN6), Guanyuan 關元(RN4). Teding Diancibo Pu (abbreviation: TDP) "特定電磁波譜" will be applied to Group B immediately after the needle insertion. This TDP device is a infra-red heat lamp which is commonly used by acupuncturists and Chinese Medicine Practitioner as a therapeutic substitute for moxibustion. The procedure will be lasted for 30 minutes in 30-40 cm above the specified acupoint Qihai 氣海(RN6) and Guanyuan 關元(RN4).
详细描述
This is a randomized, open-labelled study to study the effect of the different acupoints combination under TCM treatment principles by fNIRS.
The investigator aim to recruited 36 depression subjects and go through 6 acupuncture treatment sessions in 3 weeks. The subjects will be asked to visit the clinic for 7 times. The depression subjects will be recruited from Queen Mary Hospital, The Mental Health Association of Hong Kong (Kwun Tong center) and the community. Basic personal information, depression medical history, level of education etc will be collected for demographic use.
All eligible subjects will be asked to fill out the Patient Health Questionnaire Depression Self-test (PHQ-9) and who score 10-19 on the PHQ-9 will be entered for a Structured Clinical Interview for Hamilton Rating Scale for Depression (HAMD). This interview will be conducted in person by our psychiatrist Dr. Chan Wai-Chi from Department of Psychiatry, the University of Hong Kong in Queen Mary Hospital. They will be divided into 2 groups by randomization. (Group A n=18, Group B n=18) The participants will receive 2 acupuncture session per week for 3 consecutively weeks. In each treatment session, all subjects in both groups will receive the same amount of needle insertion ( total 14 needles) , all needles will be retained for 30 minutes. The whole treatment will last for around 45 minutes. No sedation will be conducted.
Subjects in Group A will receive 14 needles based on the TCM theory "Soothing liver-qi stagnation", all needles will be retained for 30 minutes. Acupoint combination: Taichong 太衝 (LR 3), Ligou 蠡沟 (LR 5), Zhongdu 中都(LR6), Xiguan 膝關 (LR 7), Ququan 曲泉 (LR 8), Zhangmen 章門(LR13), Qimen 期門 (LR14).
Subjects in Group B will receive 14 needles based on the TCM theory "Soothing liver-qi stagnation" and "Tonifying the heart and the spleen"and "Invigorating the Yang Qi", all needles will be retained for 30 minutes. Acupoint combination: Taichong 太衝 (LR 3), , Sanyinjiao 三陰交 (SP 6), Xuanzhong 懸鐘 (GB 39), Shenmen 神門 (HT 7), Zusanli 足三里(ST 36), Baihui 百會(DU 20), Shenting 神庭(DU24), Qihai 氣海(RN6), Guanyuan 關元(RN4). Teding Diancibo Pu (abbreviation: TDP) "特定電磁波譜" will be applied to Group B immediately after the needle insertion. This TDP device is a infra-red heat lamp which is commonly used by acupuncturists and Chinese Medicine Practitioner as a therapeutic substitute for moxibustion. The procedure will be lasted for 30 minutes in 30-40 cm above the specified acupoint Qihai 氣海(RN6) and Guanyuan 關元(RN4).
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
- None
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
- •Age between 18 and 65;
- •Primary diagnosis as moderate and moderate severe depression;
- •Patient Health Questionnaire Depression Self-test (PHQ-9) score 10-19.
排除标准
- •Patients with primary diagnosis as Major Depressive Disorder, any history of psychosis or mania.
- •Conditions that may make it difficult to conclusively determine that depressive symptoms are the result of Depression and not some other condition: any form of substance abuse or dependence within the last 6 months, relevant medical conditions that may be the medical basis of a depression including epilepsy, history of an abnormal EEG, severe head trauma, or stroke.
- •Serious uncontrolled medical conditions [e.g. poorly controlled diabetes, severe congestive heart failure], or other medical conditions that have not been stable for at least 3 months;
- •Received Electroconvulsive therapy (ECT) in the past year.
- •Current active suicidal or self-injurious potential necessitating immediate treatment
研究组 & 干预措施
Acupunture group A
The subjects will receive acupuncture treatment twice weekly for 3 weeks (6 treatments in total) Subjects in Group A will receive 14 needles based on the TCM theory "Soothing liver-qi stagnation" , all needles will be retained for 30 minutes.
干预措施: Acupunture group A (Other)
Acupunture group B
The subjects will receive acupuncture treatment twice weekly for 3 weeks (6 treatments in total). Subjects in Group B will receive 14 needles based on the TCM theory "Soothing liver-qi stagnation" and "Tonifying the heart and the spleen"and "Invigorating the Yang Qi", all needles will be retained for 30 minutes.
干预措施: Acupunture group B (Other)
结局指标
主要结局
Change of Brain activation hemodynamic signals in 6 acupuncture sessions (concentration level of Oxygenated Hemoglobin (O2Hb) over the left dorsolateral prefrontal cortex (DLPFC)
时间窗: 5 minutes before, during and 10 minutes after the 1st and the last (6th) acupuncture treatment session.
Will be measured by a customized portal fNIRS device
Change of Brain activation hemodynamic signals in 6 acupuncture sessions (Deoxygenated Hemoglobin (HHb)) over the left dorsolateral prefrontal cortex (DLPFC)
时间窗: 5 minutes before, during and 10 minutes after the 1st and the last (6th) acupuncture treatment session.
Will be measured by a customized portal fNIRS device
次要结局
- PHQ-9(1. Screening stage; 2. Before start of 1st treatment in Week 1; 3. Immediately after the 2nd treatment in Week 3;4. 1st week, 2nd week and 4th week after the last treatment, conducted by telephone)
研究者
Dr. Wu Junmei
Assistant Professor
The University of Hong Kong