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

Primary Purpose

Major Depressive Disorder, Infrared Thermography

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
infrared thermography (IRT)
Sponsored by
Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Xiaoyu Li

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy group

MDD electroacupuncture intervention group

MDD waiting-list group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 12, 2021
Last Updated
January 27, 2023
Sponsor
Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05024149
Brief Title
Assessing the Impact of Electroacupuncture on Facial Thermal Characteristics of Major Depressive Disorder Patients Based on Infrared Thermal Imaging Technology
Official Title
Assessing the Impact of Electroacupuncture on Facial Thermal Characteristics of Major Depressive Disorder Patients Based on Infrared Thermal Imaging Technology
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Infrared Thermography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy group
Arm Type
Experimental
Arm Description
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.
Arm Title
MDD electroacupuncture intervention group
Arm Type
Experimental
Arm Title
MDD waiting-list group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
infrared thermography (IRT)
Intervention Description
The temperature and infrared thermography (IRT) images of the facial acupoints of three groups will be recorded by an infrared thermal-imaging camera.
Primary Outcome Measure Information:
Title
Average facial temperature
Description
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.
Time Frame
Change from Baseline average facial temperature at 4 weeks
Secondary Outcome Measure Information:
Title
Infrared thermal images
Description
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.
Time Frame
Change from Baseline average facial temperature at 4 weeks
Title
Hamilton depression scale (HAMD)
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for healthy subjects: 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; 18 ≤ 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. Inclusion criteria for MDD patients: 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. Exclusion Criteria: Exclusion criteria for healthy subjects: 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. Exclusion criteria for MDD patients: 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; Patients suffering from cognitive dysfunction, aphasia or other diseases that cannot cooperate with treatment; Patients with pacemakers; Patients who are not suitable for EA. Note: Subjects who meet any of the above will be excluded.
Facility Information:
Facility Name
Xiaoyu Li
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310053
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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