UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062167 |
|---|---|
| Receipt number | R000071145 |
| Scientific Title | Retrospective observational analysis of clinical data from transcutaneous auricular vagus nerve stimulation (taVNS) in patients with brain injury during convalescent rehabilitation |
| Date of disclosure of the study information | 2026/07/08 |
| Last modified on | 2026/07/08 02:36:53 |
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Basic information
Public title
Retrospective observational study of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with brain injury during convalescent rehabilitation
Acronym
taVNS-Rehab Study
Scientific Title
Retrospective observational analysis of clinical data from transcutaneous auricular vagus nerve stimulation (taVNS) in patients with brain injury during convalescent rehabilitation
Scientific Title:Acronym
taVNS-Brain Injury Study
Region
| Japan |
Condition
Condition
Brain Injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to retrospectively analyze the clinical course of transcutaneous auricular vagus nerve stimulation (taVNS) performed in routine practice for patients with brain injury during convalescent rehabilitation, and to describe its safety and clinical characteristics.
Basic objectives2
Others
Basic objectives -Others
Transcutaneous auricular vagus nerve stimulation (taVNS) has been suggested to influence arousal, swallowing, and autonomic function, but clinical reports in patients with brain injury during convalescent rehabilitation remain limited. This study aims to describe clinical changes observed in routine taVNS practice and provide foundational information for future research.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Retrospective description of the clinical course, including arousal level (JCS), swallowing function (FOIS), activities of daily living (FIM), and other clinical chart documentation in patients with brain injury who received taVNS.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with brain injury (including stroke, traumatic brain injury, and medullary infarction) who were admitted to a convalescent rehabilitation ward and received transcutaneous auricular vagus nerve stimulation (taVNS) as part of routine clinical practice.
Cases with available retrospective clinical documentation were included.
Key exclusion criteria
None specifically defined due to the retrospective observational design.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Harada |
Organization
Fujimoto Kamimachi Hospital
Division name
Department of Rehabilitation Medicine
Zip code
8850072
Address
10-24 Kamimachi, Miyakonojo, Miyazaki, Japan
TEL
0986234000
kharada-ku@umin.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Harada |
Organization
Fujimoto Kamimachi Hospital
Division name
Department of Rehabilitation Medicine
Zip code
8850072
Address
10-24 Kamimachi, Miyakonojo, Miyazaki, Japan
TEL
0986234000
Homepage URL
https://www.shizuokai.or.jp/
kharada-ku@umin.ac.jp
Sponsor or person
Institute
Fujimoto Kamimachi Hospital
Institute
Department
Personal name
katsuhiro harada
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujimoto Kamimachi Hospital Clinical Research Ethics Committee
Address
10-24 Kamimachi, Miyakonojo, Miyazaki, Japan
Tel
0986234000
kharada-ku@umin.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
藤元上町病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 08 | 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
3
Results
In three subacute brain-injured patients receiving taVNS, heterogeneous responses were observed. Case 1 and Case 3 showed improvements in swallowing, arousal, and ADL, whereas Case 2 showed no clear response. No safety concerns were identified.
Results date posted
| 2026 | Year | 07 | Month | 08 | Day |
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
Completed
Date of protocol fixation
| 2026 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 12 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 07 | Month | 08 | Day |
Other
Other related information
This study is a retrospective observational case series analyzing the clinical course of transcutaneous auricular vagus nerve stimulation (taVNS) performed as part of routine care in subacute brain-injured patients. Three cases were included, and all interventions and follow-up have been completed. Data collection and analysis are also complete. Primary outcomes included swallowing function, arousal level, ADL, and overall clinical course. No adverse events were observed. Individual patient data will not be shared due to privacy considerations.
Management information
Registered date
| 2026 | Year | 07 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071145
