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

Primary Purpose

Major Depressive Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intradermal acupuncture
Sponsored by
The Third Affiliated hospital of Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder focused on measuring Major depressive disorder, Intradermal acupuncture, functional Near-Infrared Spectroscopy, Gallbladder meridian

Eligibility Criteria

15 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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; Exclusion Criteria: 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;

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Observation group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

total hemoglobin (Total-Hb)
Total hemoglobin was calculated using the combined concentrations of oxygenated hemoglobin and deoxygenated hemoglobin [Total-Hb = oxy-Hb + deoxy-Hb].
oxygenated hemoglobin (oxy-Hb)
Oxygenated hemoglobin is the combination of hemoglobin plus oxygen.
deoxygenated hemoglobin (deoxy-Hb)
Deoxygenated hemoglobin is the unbound form of hemoglobin with oxygen.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2023
Last Updated
January 22, 2023
Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05707299
Brief Title
The Effect of Intradermal Acupuncture on Gallbladder Meridian Points on Cerebral Hemodynamics in Relevant Brain Regions for Major Depressive Disorder Based on fNIRS Technology
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, Intradermal acupuncture, functional Near-Infrared Spectroscopy, Gallbladder meridian

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observation group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Intradermal acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
total hemoglobin (Total-Hb)
Description
Total hemoglobin was calculated using the combined concentrations of oxygenated hemoglobin and deoxygenated hemoglobin [Total-Hb = oxy-Hb + deoxy-Hb].
Time Frame
During the whole acupuncture operation
Title
oxygenated hemoglobin (oxy-Hb)
Description
Oxygenated hemoglobin is the combination of hemoglobin plus oxygen.
Time Frame
During the whole acupuncture operation
Title
deoxygenated hemoglobin (deoxy-Hb)
Description
Deoxygenated hemoglobin is the unbound form of hemoglobin with oxygen.
Time Frame
During the whole acupuncture operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaomei Shao, Ph.D
Phone
+8618957130287
Email
shaoxiaomei@zcmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Sangsang Xiong
Phone
+86152671382513
Email
376815403@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaomei Shao, Ph.D
Organizational Affiliation
The Third Affiliated hospital of Zhejiang Chinese Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Third affiliated hospital of Zhejiang Chinese Medical university [Recruiting]
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaomei Shao, Ph.D
Phone
+8618957130287
Email
shaoxiaomei@zcmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Sangsang Xiong
Phone
+86152671382513
Email
376815403@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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