The Effect of Intradermal Acupuncture on Gallbladder Meridian Points on Cerebral Hemodynamics in Relevant Brain Regions for Major Depressive Disorder Based on fNIRS Technology
NCT ID: NCT05707299
Last Updated: 2023-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2023-02-01
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Observation group
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.
Intradermal acupuncture
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.
Control group
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.
Intradermal acupuncture
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.
Interventions
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Intradermal acupuncture
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.
Eligibility Criteria
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Inclusion Criteria
2. 15 ≤ age ≤22 years, male or female;
3. Participants have clear consciousness and could communicate with others normally;
4. 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;
5. Participants should be right-handed;
1. MDD patients should meet the diagnostic criteria of the International Classification of Diseases 11th Edition (ICD-11) diagnostic criteria for MDD;
2. 15≤ age ≤22, male or female;
3. Participants have clear consciousness and could communicate with others normally;
4. 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;
5. Not taking antidepressants or antipsychotic drugs for at least 4 weeks before enrollment;
6. Participants should be right-handed;
Exclusion Criteria
2. Participants have an illness, alcohol dependence, or a history of drug abuse;
3. Pregnant or lactating participants;
4. Participants with intellectual disabilities who can't cooperate with the questionnaire survey;
5. Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
6. The test site of participants has scars, hyperpigmentation, red and swollen;
7. Participants are participating in other trials;
1. 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;
2. MDD caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances;
3. Participants with suicidal tendencies;
4. Pregnant or lactating participants;
5. Participants with intellectual disabilities who cannot cooperate with the questionnaire survey;
6. Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
7. The skin at the test site of participants has scars, hyperpigmentation, red and swollen;
8. Participants are participating in other trials;
15 Years
22 Years
ALL
Yes
Sponsors
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The Third Affiliated hospital of Zhejiang Chinese Medical University
OTHER
Responsible Party
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Xiaomei Shao
Prof
Principal Investigators
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Xiaomei Shao, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Third Affiliated hospital of Zhejiang Chinese Medical University
Locations
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the Third affiliated hospital of Zhejiang Chinese Medical university [Recruiting]
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Xiaomei Shao, Ph.D
Role: primary
Sangsang Xiong
Role: backup
References
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Xiong S, Tu M, Wu X, Qu S, Chen N, Jin J, Rong H, Pei S, Fang J, Shao X. Real-Time Hemodynamic Changes in the Prefrontal and Bilateral Temporal Cortices During Intradermal Acupuncture for Major Depressive Disorder: A Prospective, Single-Center, Controlled Trial Protocol. Neuropsychiatr Dis Treat. 2023 Dec 1;19:2627-2638. doi: 10.2147/NDT.S435617. eCollection 2023.
Other Identifiers
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2022ZX010-fNIRS
Identifier Type: -
Identifier Source: org_study_id