Major Depressive Disorder
Conditions
Keywords
Major depressive disorder, Intradermal acupuncture, functional Near-Infrared Spectroscopy, Gallbladder meridian
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREIntradermal acupuncture
Procedure/Surgery: Bilateral Fengchi（GB20）and Qiuxu（GB40） will be stimulated. According to the position of the acupoints, the needle of φ0.20\*1.5mm will be chosen. After acupuncture point localization and routine disinfection, all subjects will receive the acupuncture in the same order, and follow the steps of resting- stimulating-preparing-stimulating-resting to complete the acupuncture operation alternately.Before acupuncture, rest for 60s as the baseline period, and then stimulate the bilateral Fengchi（GB20） for 2 mins. After stopping stimulation, wait for fNIRS to return to the resting level (i.e., the preparation period), then stimulate the bilateral Qiuxu（GB40） for another 2 mins, and stop the near-infrared scanning when the image of fNIRS returns to the resting level.
Sponsors
The Third Affiliated hospital of Zhejiang Chinese Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 22 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for control group: 1. 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; 2. 15 ≤ age ≤22 years, male or female; 3. Participants have clear consciousness and could communicate with others normally; 4. 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; 5. Participants should be right-handed; Inclusion criteria for observation group: 1. MDD patients should meet the diagnostic criteria of the International Classification of Diseases 11th Edition (ICD-11) diagnostic criteria for MDD; 2. 15≤ age ≤22, male or female; 3. Participants have clear consciousness and could communicate with others normally; 4. 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; 5. Not taking antidepressants or antipsychotic drugs for at least 4 weeks before enrollment; 6. Participants should be right-handed;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total hemoglobin (Total-Hb） | During the whole acupuncture operation | Total hemoglobin was calculated using the combined concentrations of oxygenated hemoglobin and deoxygenated hemoglobin \[Total-Hb = oxy-Hb + deoxy-Hb\]. |
| oxygenated hemoglobin (oxy-Hb) | During the whole acupuncture operation | Oxygenated hemoglobin is the combination of hemoglobin plus oxygen. |
| deoxygenated hemoglobin (deoxy-Hb) | During the whole acupuncture operation | Deoxygenated hemoglobin is the unbound form of hemoglobin with oxygen. |
Countries
China
Contacts
Primary ContactXiaomei Shao, Ph.D
Backup ContactSangsang Xiong
Outcome results
None listed