Assessing the Impact of Electroacupuncture on Facial Thermal Characteristics of Major Depressive Disorder Patients Based on Infrared Thermal Imaging Technology

Three groups of subjects will be included: 20 subjects in the healthy control group, 20 subjects in the MDD electroacupuncture (EA) intervention group, and 20 subjects in the MDD waiting-list group (participants will receive no treatment within 4 weeks). The temperature and infrared thermography (IRT) images of the facial acupoints of three groups will be recorded by an infrared thermal-imaging camera. The average facial temperature and acupoints temperature will be analyzed and compared within 3 groups. In addition, the correlation between facial infrared radiation characteristics of MDD patients and emotional changes will be explored. Besides, the relative specificity of the two meridians will be investigated.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder; Infrared Thermography
• Intervention / Treatment: Other: infrared thermography (IRT)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310053
      • Recruiting
      • Xiaoyu Li
      • Contact: Xiaoyu Li; Phone Number: +8618758240921; Email: 673426608@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Inclusion criteria for healthy subjects:

1. Healthy subjects should provide a physical examination report within the last year, which could confirm they had not major systemic diseases, such as cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological disease;
2. 18 ≤ age ≤ 60 years, both gender;
3. Subjects have clear consciousness and could communicate with others normally;
4. Subjects could understand the full study protocol and written informed consent is provided by themselves. Note: Subjects who meet the above four items will be included.

Inclusion criteria for MDD patients:

1. Meeting the above diagnostic criteria for MDD;
2. PHQ-9 score of 5 to 14, HAMD score of 21 to 35, and a diagnosis of mild or moderate depression by a specialist; (3)18 ≤ age ≤ 60 years, both gender;

(4) Patients have clear consciousness and could communicate with others normally; (5) Patients could understand the full study protocol and written informed consent is provided by themselves; (6) Those who did not use other therapies other than the basic treatment and this experimental therapy. The basic treatment refers to basic antidepressant medications under the supervision of a specialist. The basic antidepressant medications are Selective Serotonin Reuptake Inhibitors, Serotonin-Norepinephrine Reuptake Inhibitors, Norepinephrine-Dopamine Reuptake Inhibitors, Tricyclic antidepressants, Monoamine Oxidase Inhibitors. Note: Subjects who meet the above six items will be included.

Exclusion Criteria:

Exclusion criteria for healthy subjects:

1. Subjects suffering from mental illness, severe depression, alcohol dependence or a history of drug abuse;
2. Subjects in pregnancy, lactation or menstrual period;
3. Subjects have a fever;
4. Subjects have visible skin damage or scars in the face;
5. Subjects participating in other trials. Note: Subjects who meet any of the above will be excluded.

Exclusion criteria for MDD patients:

1. Patients with bipolar disorder;
2. Patients with schizophrenia or other mental disorders;
3. Patients with severe medical diseases, tumors or diseases of the central nervous system;
4. Patients suffering from severe depressive episode with psychotic symptoms;
5. Suicidal patients;
6. Patients with seasonal depression;
7. Patients with organic depression;
8. Patients with alcohol or drug addicts;
9. Patients using other therapies;
10. Patients in pregnancy or lactation;
11. Patients suffering from cognitive dysfunction, aphasia or other diseases that cannot cooperate with treatment;
12. Patients with pacemakers;
13. Patients who are not suitable for EA. Note: Subjects who meet any of the above will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy group; Subjects in this group will not undergo acupuncture intervention. For participants in the healthy control group, the IRT examination of the measurement sites will last for 3 minutes, with one thermal image taken every 10s. In the Healthy group, there will be two visits, and the first visit will be considered as the screening stage (i.e., demographic data recording, medical history taking, physical examination report review and recording on the day of enrollment) and the second visit will be considered as the detection stage (i.e., the day of enrollment). At the second visit, the subjects received the Self-rating depression scale (SDS), HAMD, and then the infrared thermographic images to be acquired.	Other: infrared thermography (IRT); The temperature and infrared thermography (IRT) images of the facial acupoints of three groups will be recorded by an infrared thermal-imaging camera.
Experimental: MDD electroacupuncture intervention group	Other: infrared thermography (IRT); The temperature and infrared thermography (IRT) images of the facial acupoints of three groups will be recorded by an infrared thermal-imaging camera.
Experimental: MDD waiting-list group; In this study, we used a waiting list control group. During the 4 weeks follow-up period, participants from the MDD waiting-list group had no contact with participants from the MDD EA intervention group and no access to the EA intervention. After the 4 weeks follow-up period, patients in the waiting list group received access to the EA intervention.	Other: infrared thermography (IRT); The temperature and infrared thermography (IRT) images of the facial acupoints of three groups will be recorded by an infrared thermal-imaging camera.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average facial temperature	Take the average facial temperature of 10 infrared images as the observation index, observe the change rule of the average temperature of MDD patient by comparing with healthy people.	Change from Baseline average facial temperature at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infrared thermal images	Direct contrast comparisons of the approximate distribution area of the high temperature and low temperature zone of the face between healthy subjects versus MDD patients will be done using software analyses.	Change from Baseline average facial temperature at 4 weeks
Hamilton depression scale (HAMD)	This scale is performed by two trained raters to perform a Hamilton depression scale (HAMD), usually in the form of conversation and observation. After the examination, the two raters will score independently. HAMD score of 21 to 35 values, and higher scores mean a worse outcome.	HAMD will be performed in the first week, the second week and the fourth week to evaluate the severity of the disease and the treatment effect.

Collaborators and Investigators

• Sponsor: Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2020YKJ04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No