UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056814 |
|---|---|
| Receipt number | R000064885 |
| Scientific Title | Changes in cerebral blood flow during acupressure in patients with chronic disorders of consciousness after severe traumatic brain injury |
| Date of disclosure of the study information | 2025/01/25 |
| Last modified on | 2025/01/25 11:16:25 |
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Basic information
Public title
Changes in cerebral blood flow during acupressure in patients with chronic disorders of consciousness after severe traumatic brain injury
Acronym
Changes in cerebral blood flow during acupressure in patients with chronic disorders of consciousness after severe traumatic brain injury
Scientific Title
Changes in cerebral blood flow during acupressure in patients with chronic disorders of consciousness after severe traumatic brain injury
Scientific Title:Acronym
Changes in cerebral blood flow during acupressure in patients with chronic disorders of consciousness after severe traumatic brain injury
Region
| Japan |
Condition
Condition
Severe traumatic brain injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe changes in cerebral blood flow during acupressure in patients with disorders of consciousness after severe traumatic brain injury
Basic objectives2
Others
Basic objectives -Others
Observation of changes between before and after acupoint stimulation
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Changes in oxyhemoglobin in the frontal lobe during acupressure measured by near-infrared spectroscopy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
acupressure
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with severe traumatic brain injury who are admitted in the Chubu Medical Center, Chubu Neurorehabilitation Hospital
2) Written informed consent is available from the patient's family
3) Patients who can maintain rest during the NIRS measurement
Key exclusion criteria
1) Severe injury of frontal cortex
2) Severe injury or loss of frontal bone.
3) Not suitable due to injury of acupressure stimulation area, etc.
4) Not stable condition in vital signs
5) Patients who could not maintain the rest or position suitable for NIRS measurement.
6) Not suitable according to doctor's judgment.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hirohito |
| Middle name | |
| Last name | Yano |
Organization
Chubu Neurorehabilitation Hospital
Division name
Chubu Medical Center For Prolonged Traumatic Brain Dysfunction
Zip code
505-0034
Address
Shimokobi 630, Kobicho, Minokamo, Gifu, Japan
TEL
0574-24-2233
hirohito@herb.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hirohito |
| Middle name | |
| Last name | Yano |
Organization
Chubu Neurorehabilitation Hospital
Division name
Chubu Medical Center for Prolonged Traumatic Brain Dysfunction
Zip code
505-0034
Address
Shimokobi 630, Kobicho, Minokamo, Gifu
TEL
0572-24-2233
Homepage URL
hirohito@herb.ocn.ne.jp
Sponsor or person
Institute
Chubu Medical Center for Prolonged Traumatic Brain Dysfunction, Chubu Neurorehabilitation Hospital
Institute
Department
Personal name
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
Ethics Committee of Chubu Neurorehabilitation Hospital
Address
Shimokobi 630, Kobicho, Minokamo, Gifu, Japan
Tel
0574-24-2233
m-kumagai@cnrh.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
中部脳リハビリテーション病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 01 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064885
