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

NCT05707299 | Unknown

• 1 other identifier: 2022ZX010-fNIRS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder; Intradermal acupuncture; functional Near-Infrared Spectroscopy; Gallbladder meridian

Outcome Measures

Primary Outcomes (3)

• total hemoglobin (Total-Hb）

  Total hemoglobin was calculated using the combined concentrations of oxygenated hemoglobin and deoxygenated hemoglobin \[Total-Hb = oxy-Hb + deoxy-Hb\].

  During the whole acupuncture operation

• oxygenated hemoglobin (oxy-Hb)

  Oxygenated hemoglobin is the combination of hemoglobin plus oxygen.

  During the whole acupuncture operation

• deoxygenated hemoglobin (deoxy-Hb)

  Deoxygenated hemoglobin is the unbound form of hemoglobin with oxygen.

  During the whole acupuncture operation

Study Arms (2)

Observation group

EXPERIMENTAL

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.

Procedure: Intradermal acupuncture

Control group

OTHER

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.

Procedure: Intradermal acupuncture

Interventions

Intradermal acupuncture PROCEDURE

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.

Control group; Observation group

Eligibility Criteria

• Age: 15 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;
• ≤ 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;
• MDD patients should meet the diagnostic criteria of the International Classification of Diseases 11th Edition (ICD-11) diagnostic criteria for MDD;
• ≤ 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university [Recruiting]

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• Xiong S, Tu M, Wu X, Qu S, Chen N, Jin J, Rong H, Pei S, Fang J, Shao X. Real-Time Hemodynamic Changes in the Prefrontal and Bilateral Temporal Cortices During Intradermal Acupuncture for Major Depressive Disorder: A Prospective, Single-Center, Controlled Trial Protocol. Neuropsychiatr Dis Treat. 2023 Dec 1;19:2627-2638. doi: 10.2147/NDT.S435617. eCollection 2023.

  PMID: 38059202 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Xiaomei Shao, Ph.D

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomei Shao, Ph.D

CONTACT

+8618957130287; shaoxiaomei@zcmu.edu.cn

Sangsang Xiong

CONTACT

+86152671382513; 376815403@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 22, 2023
• First Posted: January 31, 2023
• Study Start: February 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)