The Effect of Intradermal Acupuncture on Gallbladder Meridian Points on Cerebral Hemodynamics in Relevant Brain Regions for Major Depressive Disorder Based on fNIRS Technology

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Not yet enrolling

Conditions: Major Depressive Disorder

Treatments: Procedure: Intradermal acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05707299

2022ZX010-fNIRS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 15 to 22 years old

Volunteers: Accepts Healthy Volunteers

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;

Exclusion criteria

Exclusion criteria for control group:

1. Participants with serious primary diseases of cardiovascular diseases, liver diseases, kidney diseases, urinary diseases, and hematological diseases;
2. Participants have an illness, alcohol dependence, or a history of drug abuse;
3. Pregnant or lactating participants;
4. Participants with intellectual disabilities who can't cooperate with the questionnaire survey;
5. Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
6. The test site of participants has scars, hyperpigmentation, red and swollen;
7. Participants are participating in other trials;

Exclusion criteria for observation group:

1. 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;
2. MDD caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances;
3. Participants with suicidal tendencies;
4. Pregnant or lactating participants;
5. Participants with intellectual disabilities who cannot cooperate with the questionnaire survey;
6. Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
7. The skin at the test site of participants has scars, hyperpigmentation, red and swollen;
8. Participants are participating in other trials;

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Observation group

Experimental group

Description:

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.

Treatment:

Procedure: Intradermal acupuncture

Control group

Other group

Description:

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.

Treatment:

Procedure: Intradermal acupuncture