UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043004
Receipt No. R000049098
Scientific Title Association between the resting glucose metabolism in the primary motor cortex and finger voluntariness in patients with severe traumatic brain injury
Date of disclosure of the study information 2021/01/14
Last modified on 2021/01/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Association between the resting glucose metabolism in the primary motor cortex and finger voluntariness in patients with severe traumatic brain injury
Acronym Finger FDGPET for sTBI
Scientific Title Association between the resting glucose metabolism in the primary motor cortex and finger voluntariness in patients with severe traumatic brain injury
Scientific Title:Acronym Finger FDGPET for sTBI
Region
Japan

Condition
Condition Chronic severe traumatic brain injury
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the association between the resting glucose metabolism in the primary motor cortex and finger voluntariness in patients with severe traumatic brain injury by 18F-FDGPET/CT
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SUV and Video judgment
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 1. Subjects who are hospitalized in our center
2. Subjects who took 18F-FDG PETCT between October 2019 and October 2020
2.Subjects who have provide informed consent by themselves or their family and adhere to the protocol
Key exclusion criteria 1.Subjects who have medical instability and cannot perform examinations safely
2.Subjects who cannot provide informed consent and adhere to the protocol
3.Subjects who are not performed 18F-FDG PETCT
4.Subjects who have difficulty bending and extending their fingers (Modified Ashworth Scale 4)
5. Subjects who have spinal cord injury in the past
6. Subjects with poor control of diabetes mellitus
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Tomohiro
Middle name
Last name Yamaki
Organization Rehabilitation Center for Traumatic Apallics Chiba
Division name Neurosurgery & PET imaging division
Zip code 261-0012
Address 3-30-1 Isobe, Mihama-ku, Chiba-city, Chiba, Japan
TEL 043-277-0061
Email t-yamaki@chiba-ryougo.jp

Public contact
Name of contact person
1st name Takemi
Middle name
Last name Murayama
Organization Rehabilitation Center for Traumatic Apallics Chiba
Division name Neurosurgery & Rehabilitation division
Zip code 261-0012
Address 3-30-1 Isobe, Mihama-ku, Chiba-shi, Chiba, 261-0012, Japan
TEL 043-277-0061
Homepage URL
Email t-murayama@chiba-ryougo.jp

Sponsor
Institute Rehabilitation Center for Traumatic Apallics Chiba
Institute
Department

Funding Source
Organization Self funding
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 Rehabilitation Center for Traumatic Apallics Chiba
Address 3-30-1 Isobe, Mihama-ku, Chiba-shi, Chiba, 261-0012, Japan
Tel 043-277-0061
Email takahito-seki@chiba-ryougo.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
2021 Year 01 Month 14 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
2020 Year 11 Month 27 Day
Date of IRB
2020 Year 12 Month 16 Day
Anticipated trial start date
2021 Year 01 Month 14 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2021 Year 01 Month 14 Day
Last modified on
2021 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049098

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.