UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061568 |
|---|---|
| Receipt number | R000070446 |
| Scientific Title | Immediate effects of electroacupuncture on prefrontal cortex function, mood, and pain in major depressive disorder with pain: A functional near-infrared spectroscopy study |
| Date of disclosure of the study information | 2026/05/15 |
| Last modified on | 2026/05/14 14:36:24 |
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Basic information
Public title
Immediate effects of electroacupuncture for depressed patients with pain: An fNIRS study
Acronym
BEAT-fNIRS
Scientific Title
Immediate effects of electroacupuncture on prefrontal cortex function, mood, and pain in major depressive disorder with pain: A functional near-infrared spectroscopy study
Scientific Title:Acronym
BEAT-fNIRS
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the immediate effects of acupuncture on brain activity in depressed patients with pain, by measuring changes in oxygenated hemoglobin (Oxy-Hb) concentration using functional near-infrared spectroscopy (fNIRS). Specifically, the study aims to: (1) evaluate changes in prefrontal cortex activity during acupuncture stimulation; (2) examine changes in brain activity during the Verbal Fluency Task (VFT), as well as subjective pain and mood, before and after acupuncture; and (3) clarify the correlations between prefrontal cortex activity changes and various clinical indicators.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in the mean change of Oxy-Hb concentration in the prefrontal cortex
Key secondary outcomes
Changes in Oxy-Hb concentration in the prefrontal cortex and the number of words generated during the VFT
Changes in pain intensity
Changes in mood states
Correlations between changes in Oxy-Hb concentration in the prefrontal cortex and clinical indicators
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Electroacupuncture
Interventions/Control_2
Minimal acupuncture
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women aged 18 to 64 years.
2) Diagnosis of Major Depressive Disorder (MDD) based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, Text Revision (DSM-5-TR) and structured interview using the Mini-International Neuropsychiatric Interview (M.I.N.I.).
3) Hamilton Depression Rating Scale (HAM-D) score of 8 or higher.
4) Pain Visual Analogue Scale (VAS) score of 30 mm or higher.
Key exclusion criteria
1) Comorbidity of other psychiatric disorders, such as schizophrenia or bipolar disorder.
2) History of cerebrovascular disease, malignant tumor, head injury, or neurodegenerative diseases such as Parkinson's disease.
3) Pregnant women, lactating women, or women of childbearing potential who may be pregnant.
4) Severe suicidal ideation.
5) Substance dependence or drug abuse.
6) Contraindications to electroacupuncture.
7) Previous experience of acupuncture treatment within the past month.
8) Individuals judged to be inappropriate for inclusion in the study by the principal investigator or sub-investigator.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Matsuo |
Organization
Saitama Medical University Hospital
Division name
Department of Psychiatry
Zip code
350-0495
Address
8 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1214
kmatsuo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Matsuura |
Organization
Saitama Medical University Hospital
Division name
Department of Oriental Medicine
Zip code
350-0495
Address
8 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1214
Homepage URL
matsuuray@tau.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for Oriental Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Saitama Medical University Hospital
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama, Japan
Tel
049-276-1354
matsuuray@tau.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070446
