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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017520
Receipt No. R000020305
Scientific Title Changes in cerebral blood flow by acupuncture treatment in patients with severe traumatic brain injury -A PET activation study-
Date of disclosure of the study information 2015/05/12
Last modified on 2021/09/04

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Basic information
Public title Changes in cerebral blood flow by acupuncture treatment in patients with severe traumatic brain injury -A PET activation study-
Acronym Acupuncture and cerebral blood flow in patients with traumatic brain injury
Scientific Title Changes in cerebral blood flow by acupuncture treatment in patients with severe traumatic brain injury -A PET activation study-
Scientific Title:Acronym Acupuncture and cerebral blood flow in patients with traumatic brain injury
Region
Japan

Condition
Condition Chronic disorder of consciousness and severe cognitive disorder (higher brain dysfunction) following traumatic brain injury
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate changes in cerebral blood flow by acupuncture treatment in patients following severe traumatic brain injury
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Changes in cerebral blood flow using [15O]H2O-PET
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Acupuncture
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 following severe traumatic brain injury, who are admitting in Chubu Medical Center for Traumatic Brain Dysfunction, Kizawa Memorial Hospital

At least three months after injury
Key exclusion criteria Subjects who are not stable in general condition

Subjects who can't keep the resting position during treatment and measurements

Ineligibility for the study based on the decision of an investigator
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Asano
Organization Chubu Medical Center for Prolonged Brain dysfunction, Kizawa Memorial Hospital
Division name Department of Neurosurgery
Zip code
Address 630, Shimo-kobi, Kobi-cho, Minokamo, Gifu, Japan
TEL 0574-24-2233
Email y-asano@wind.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Asano Yuka Ikegame
Organization Chubu Medical Center for Prolonged Brain dysfunction, Kizawa Memorial Hospital
Division name Department of Neurosurgery
Zip code
Address 630, Shimo-kobi, Kobi-cho, Minokamo, Gifu, Japan
TEL 0574-24-2233
Homepage URL
Email y-asano@wind.ocn.ne.jp

Sponsor
Institute Chubu Medical Center for Prolonged Traumatic Brain Dysfunction, Kizawa Memorial Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 05 Month 12 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 Completed
Date of protocol fixation
2015 Year 03 Month 15 Day
Date of IRB
2015 Year 03 Month 23 Day
Anticipated trial start date
2015 Year 05 Month 12 Day
Last follow-up date
2019 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 12 Day
Last modified on
2021 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020305

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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