UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective analysis of brain metabolism changes associated with treatment for patients with chronic brain injury
Acronym	Retrospective analysis of brain metabolism changes associated with treatment for patients with chronic brain injury
Scientific Title	Retrospective analysis of brain metabolism changes associated with treatment for patients with chronic brain injury
Scientific Title:Acronym	Retrospective analysis of brain metabolism changes associated with treatment for patients with chronic brain injury
Region	Japan

Condition
Condition	Brain injury
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We retrospectively analyzed PET/CT images taken before and after treatment, which is presumed to change brain metabolism in clinical symptoms, and investigated the effects of each treatment on brain metabolism for the purpose of confirming brain metabolic changes.
Basic objectives2	Others
Basic objectives -Others	We facilitate the planning of rehabilitation programs and the development of assistive devices for brain injury patients in future.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Standardized uptake value (SUV), Lesion-to-normal uptake ratio (L/N)
Key secondary outcomes	Clinical evaluation, ABR/VEP/EEG, CT/MRI, blood analysis data, information of drug and surgical treatments

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) Patients who have been hospitalized at the Rehabilitation Center for Traumatic Apallics Chiba. (2) Patients whose general condition is stable and who can be safely examined. (3) Patients who have given written informed consent voluntarily from the patient himself/herself or from the legal representative of the patient who lacks the ability to consent after receiving a sufficient explanation for participating in this study.
Key exclusion criteria	(1) Patients whose general condition is unstable and cannot be safely examined. (2) Patients who could not obtain written consent. (3) Patients judged by the research investigator to be inappropriate for this study.
Target sample size	250

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
Zip code	261-0012
Address	3-30-1 Isobe, Mihama-ku, chiba-shi, Chiba, Japan
TEL	043-277-0061
Email	t-yamaki@chiba-ryougo.jp

Public contact
Name of contact person	1st name Takahito Middle name Last name Seki
Organization	Rehabilitation Center for Traumatic Apallics Chiba
Division name	Medical accounting section
Zip code	261-0012
Address	3-30-1 Isobe, Mihama-ku, chiba-shi, Chiba, Japan
TEL	043-277-0061
Homepage URL
Email	takahito-seki@chiba-ryougo.jp

Sponsor
Institute	Rehabilitation Center for Traumatic Apallics Chiba
Institute
Department

Funding Source
Organization	Rehabilitation Center for Traumatic Apallics Chiba
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, 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	自動車事故対策機構　千葉療護センター

Other administrative information
Date of disclosure of the study information	2022 Year 08 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	2022 Year 03 Month 24 Day
Date of IRB	2022 Year 03 Month 24 Day
Anticipated trial start date	2022 Year 08 Month 25 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective observational analysis

Management information
Registered date	2022 Year 08 Month 25 Day
Last modified on	2022 Year 08 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055541