Major Depressive DisorderNCT05707299
The Effect of Intradermal Acupuncture on Gallbladder Meridian Points on Cerebral Hemodynamics in Relevant Brain Regions for Major Depressive Disorder Based on fNIRS Technology
A study testing Intradermal acupuncture in people with Major Depressive Disorder, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
Gallbladder meridian(GB) acupoints may play an important role in the treatment of major depressive disorder (MDD). Therefore, this study is designed to focus on the traditional Chinese medicine (TCM) theory of " gallbladder dominating decision ", take the GB as the entry point, and use functional Near-Infrared… Read more about this study
- Who is it for?
- Ages 15 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Intradermal acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy control participants who could provide a recent depression screening report, and confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
- 15 ≤ age ≤22 years, male or female;
- Participants have clear consciousness and could communicate with others normally;
- 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;
- Participants should be right-handed;
- MDD patients should meet the diagnostic criteria of the International Classification of Diseases 11th Edition (ICD-11) diagnostic criteria for MDD;
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- 15≤ age ≤22, male or female;
- Participants have clear consciousness and could communicate with others normally;
- 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;
- Not taking antidepressants or antipsychotic drugs for at least 4 weeks before enrollment;
- Participants should be right-handed;
Who cannot join
- Participants with serious primary diseases of cardiovascular diseases, liver diseases, kidney diseases, urinary diseases, and hematological diseases;
- Participants have an illness, alcohol dependence, or a history of drug abuse;
- Pregnant or lactating participants;
- Participants with intellectual disabilities who can't cooperate with the questionnaire survey;
- Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
- The test site of participants has scars, hyperpigmentation, red and swollen;
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- Participants are participating in other trials;
- 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;
- MDD caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances;
- Participants with suicidal tendencies;
- Pregnant or lactating participants;
- Participants with intellectual disabilities who cannot cooperate with the questionnaire survey;
- Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
- The skin at the test site of participants has scars, hyperpigmentation, red and swollen;
- Participants are participating in other trials;
Trial locations and contacts
1 site in 1 country.
China1 site
the Third affiliated hospital of Zhejiang Chinese Medical university [Recruiting]
Hangzhou, Zhejiang
Xiaomei Shao, Ph.D, +8618957130287, shaoxiaomei@zcmu.edu.cn
Sangsang Xiong, +86152671382513, 376815403@qq.com
About this study
Official title: The Effect of Intradermal Acupuncture on Gallbladder Meridian Points on Cerebral Hemodynamics in Relevant Brain Regions for Major Depressive Disorder Based on fNIRS Technology: Study Protocol of a Prospective, Single-center, Controlled Trial
Gallbladder meridian(GB) acupoints may play an important role in the treatment of major depressive disorder (MDD). Therefore, this study is designed to focus on the traditional Chinese medicine (TCM) theory of " gallbladder dominating decision ", take the GB as the entry point, and use functional Near-Infrared Spectroscopy(fNIRS) technology to observe the effect of intradermal acupuncture on the cerebral hemodynamic indexes of the prefrontal cortex and bilateral temporal cortex of patients with MDD.
Read the detailed description
This study will include 20 patients with MDD (observation group) and 20 healthy control participants without MDD (control group). fNIRS will be adopted to assess regional oxygen saturation of the blood in the MDD-related cerebral cortex: the prefrontal and bilateral temporal cortex. Based on the results of the fNIRS, to explore cerebral hemodynamic changes in the prefrontal and bilateral temporal cortex in patients with MDD. By observing the changes of hemodynamic characteristics of the prefrontal cortex and bilateral temporal cortex of the observation group and the control group during the course of intradermal acupuncture, explore the immediate response of the hemodynamic characteristics of the prefrontal cortex and bilateral temporal cortex of the observation group to the intervention of the GB acupoints.
- Conditions
- Major Depressive Disorder
- Being tested
- Intradermal acupuncture
- Keywords
- Major depressive disorder, Intradermal acupuncture, functional Near-Infrared Spectroscopy, Gallbladder meridian
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal acupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Experimental | 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. Receives: Procedure: Intradermal acupuncture |
| Control group | Other | 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. Receives: Procedure: Intradermal acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
total hemoglobin (Total-Hb）
Total hemoglobin was calculated using the combined concentrations of oxygenated hemoglobin and deoxygenated hemoglobin [Total-Hb = oxy-Hb + deoxy-Hb].
Measured: During the whole acupuncture operation
oxygenated hemoglobin (oxy-Hb)
Oxygenated hemoglobin is the combination of hemoglobin plus oxygen.
Measured: During the whole acupuncture operation
deoxygenated hemoglobin (deoxy-Hb)
Deoxygenated hemoglobin is the unbound form of hemoglobin with oxygen.
Measured: During the whole acupuncture operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaomei Shao, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Xiaomei Shao, Ph.D, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707299
- Sponsor's protocol ID
- 2022ZX010-fNIRS
- Status last verified
- Jan 2023
- First submitted
- 22 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38059202
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intradermal Acupuncture on Gallbladder Meridian Points on Cerebral Hemodynamics in Relevant Brain Regions for Major Depressive Disorder Based on fNIRS Technology: Study Protocol of a Prospective, Single-center, Controlled Trial
- ClinicalTrials.gov ID
- NCT05707299
- Acronym / sponsor ID
- 2022ZX010-fNIRS
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, Intradermal acupuncture, functional Near-Infrared Spectroscopy, Gallbladder meridian
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gallbladder meridian(GB) acupoints may play an important role in the treatment of major depressive disorder (MDD). Therefore, this study is designed to focus on the traditional Chinese medicine (TCM) theory of " gallbladder dominating decision ", take the GB as the entry point, and use functional Near-Infrared Spectroscopy(fNIRS) technology to observe the effect of intradermal acupuncture on the cerebral hemodynamic indexes of the prefrontal cortex and bilateral temporal cortex of patients with MDD.
Detailed description
This study will include 20 patients with MDD (observation group) and 20 healthy control participants without MDD (control group). fNIRS will be adopted to assess regional oxygen saturation of the blood in the MDD-related cerebral cortex: the prefrontal and bilateral temporal cortex. Based on the results of the fNIRS, to explore cerebral hemodynamic changes in the prefrontal and bilateral temporal cortex in patients with MDD. By observing the changes of hemodynamic characteristics of the prefrontal cortex and bilateral temporal cortex of the observation group and the control group during the course of intradermal acupuncture, explore the immediate response of the hemodynamic characteristics of the prefrontal cortex and bilateral temporal cortex of the observation group to the intervention of the GB acupoints.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation group | Experimental | Procedure: Intradermal acupunctureThis 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. |
| Control group | Other | Procedure: Intradermal acupunctureThis 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. |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Healthy control participants who could provide a recent depression screening report, and confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
- 15 ≤ age ≤22 years, male or female;
- Participants have clear consciousness and could communicate with others normally;
- 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;
- Participants should be right-handed;
Key exclusion criteria (15 listed)
- Participants with serious primary diseases of cardiovascular diseases, liver diseases, kidney diseases, urinary diseases, and hematological diseases;
- Participants have an illness, alcohol dependence, or a history of drug abuse;
- Pregnant or lactating participants;
- Participants with intellectual disabilities who can't cooperate with the questionnaire survey;
- Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradermal acupunctureProcedure/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. | Procedure or surgery | Control group, Observation group |
Primary outcome
total hemoglobin (Total-Hb）
Time frame: During the whole acupuncture operation
Total hemoglobin was calculated using the combined concentrations of oxygenated hemoglobin and deoxygenated hemoglobin [Total-Hb = oxy-Hb + deoxy-Hb].
oxygenated hemoglobin (oxy-Hb)
Time frame: During the whole acupuncture operation
Oxygenated hemoglobin is the combination of hemoglobin plus oxygen.
deoxygenated hemoglobin (deoxy-Hb)
Time frame: During the whole acupuncture operation
Deoxygenated hemoglobin is the unbound form of hemoglobin with oxygen.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 38059202Xiong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaomei Shao, Ph.D principal investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradermal acupuncture in people with Major Depressive Disorder, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaomei Shao, Ph.D (+8618957130287, shaoxiaomei@zcmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total hemoglobin (Total-Hb） (time frame: During the whole acupuncture operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05707299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.