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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05024149
• Other study ID #: 2020YKJ04
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2023
• Source: Zhejiang Chinese Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 su?ering 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 su?ering 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Infrared Thermography
• Major Depressive Disorder

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.

Locations

Country	Name	City	State
China	Xiaoyu Li	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.