UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060816 |
|---|---|
| Receipt number | R000069585 |
| Scientific Title | Effects of linearly polarized near-infrared laser irradiation near the stellate ganglion on autonomic nerves and electroencephalograms |
| Date of disclosure of the study information | 2026/03/04 |
| Last modified on | 2026/03/04 11:14:12 |
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Basic information
Public title
Effects of linearly polarized near-infrared laser irradiation near the stellate ganglion on autonomic nerves and electroencephalograms
Acronym
Effects of linearly polarized near-infrared laser irradiation near the stellate ganglion on autonomic nerves and electroencephalograms
Scientific Title
Effects of linearly polarized near-infrared laser irradiation near the stellate ganglion on autonomic nerves and electroencephalograms
Scientific Title:Acronym
Effects of linearly polarized near-infrared laser irradiation near the stellate ganglion on autonomic nerves and electroencephalograms
Region
| Japan |
Condition
Condition
People without the disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate how irradiation of the stellate ganglion with a linearly polarized near-infrared laser affects electroencephalograms and autonomic nervous function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autonomic nervous system (LF/HF, HF, LF)
Key secondary outcomes
EEG, circulatory dynamics, respiratory rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Linearly polarized near-infrared irradiation (probe placed near the stellate ganglion)
Interventions/Control_2
No irradiation (probe placed near the stellate ganglion)
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Individuals without illness
Women aged 20-40
Volunteers (recruited via posters)
Key exclusion criteria
Patients with a disease affecting the autonomic nervous system or electroencephalogram (EEG)
Past smoking history
Patients taking regular medication
Women who are pregnant, may be pregnant, are within 28 days of giving birth, or are breastfeeding
Patients deemed inappropriate for study participation due to psychiatric illness or symptoms
Patients with photosensitivity
Other patients deemed inappropriate by a physician
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yozo |
| Middle name | |
| Last name | Manabe |
Organization
Kagoshima University Hospital
Division name
Dental Anesthesiology
Zip code
890-0075
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima Prefecture
TEL
099-275-6288
kaorun@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Yamashita |
Organization
Kagoshima University Hospital
Division name
Dental Anesthesiology
Zip code
8900075
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima Prefecture
TEL
099-275-6288
Homepage URL
kaorun@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University
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
Kagoshima University Hospital Clinical Research Management Center
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima Prefecture
Tel
099-275-6624
crmc@m2.kufm.kagoshima-u.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 | 03 | Month | 04 | 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
18
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The reason for the delay in publication is that the paper has not yet been submitted.
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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2023 | 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 | 03 | Month | 04 | Day |
Last modified on
| 2026 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069585
