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

NCT05024149 | Unknown

• 1 other identifier: 2020YKJ04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder; Infrared Thermography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Infrared thermal images

  Change from Baseline average facial temperature at 4 weeks

• Hamilton depression scale (HAMD)

  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.

Study Arms (3)

Healthy group

EXPERIMENTAL

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)

MDD electroacupuncture intervention group

EXPERIMENTAL

Other: infrared thermography (IRT)

MDD waiting-list group

EXPERIMENTAL

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)

Interventions

infrared thermography (IRT) OTHER

The temperature and infrared thermography (IRT) images of the facial acupoints of three groups will be recorded by an infrared thermal-imaging camera.

Healthy group; MDD electroacupuncture intervention group; MDD waiting-list group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• ≤ age ≤ 60 years, both gender;
• Subjects have clear consciousness and could communicate with others normally;
• 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.
• Meeting the above diagnostic criteria for MDD;
• 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.

You may not qualify if:

• Subjects suffering from mental illness, severe depression, alcohol dependence or a history of drug abuse;
• Subjects in pregnancy, lactation or menstrual period;
• Subjects have a fever;
• Subjects have visible skin damage or scars in the face;
• Subjects participating in other trials. Note: Subjects who meet any of the above will be excluded.
• Patients with bipolar disorder;
• Patients with schizophrenia or other mental disorders;
• Patients with severe medical diseases, tumors or diseases of the central nervous system;
• Patients suffering from severe depressive episode with psychotic symptoms;
• Suicidal patients;
• Patients with seasonal depression;
• Patients with organic depression;
• Patients with alcohol or drug addicts;
• Patients using other therapies;
• Patients in pregnancy or lactation;

Sponsors & Collaborators

• Zhejiang Chinese Medical University: lead

Study Sites (1)

Xiaoyu Li

Hangzhou, Zhejiang, 310053, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 27, 2021
• Study Start: July 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

CN (1)