UMIN-CTR Clinical Trial

Public title

A study and Exploratory Clinical trial on chronological changes of the Iomazenil SPECT in coping with Higher brain dysfunction after cerebral trauma

Acronym

A study and Exploratory Clinical trial on chronological changes of the Iomazenil SPECT in coping with Higher brain dysfunction after cerebral trauma

Scientific Title

A study and Exploratory Clinical trial on chronological changes of the Iomazenil SPECT in coping with Higher brain dysfunction after cerebral trauma

Scientific Title:Acronym

A study and Exploratory Clinical trial on chronological changes of the Iomazenil SPECT in coping with Higher brain dysfunction after cerebral trauma

Region

Japan

Condition

Higher brain dysfunction following traumatic brain injury

Classification by specialty

Neurosurgery

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examined chronological changes of IomazenilSPECT is checked in higher brain dysfunction by cerebral trauma, and determine what an abnormal findings site means, primary injury or the second injury, whether there is reversibility, and examine it prosepectively how it is associated with the change of the nerve psychological test and clinical manifestations prospectively, and how it is associated with findings of the MRI

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

<Efficacy>
Presence or absence of changes of IMZ-SPECT one year later

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Diagnosis by Iomazenil SPECT

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

Age-lower limit

15

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who present with higher brain dysfunction by cerebral trauma (TBI) who are are visiting a hospital for treatment or the hospitalized patient in a Hokkaido University Hospital Rehabilitation Medicine
(1) The Age is more than 15-year-old patient at the agreement acquisition. The sex does not matter.
(2) The patients without the contraindication for the MRI and SPECT as a preoperative routine imaging study
(3) The patients that a document agreement by the free will of the patients or legal representative was obtained after having received enough explanation and understanding in participation of this study
(4) The patients who are more than 2 months after injury
(5) The patients without the contraindication for the Standard therapies method including the rehabilitation

Key exclusion criteria

(1) The patients who cannot discontinue benzodiazepine drugs for one week
(2) The patients who cannot conduct various tests such as nerve psychological tests
(3) The patients with a history of other mental disorder and neurologic disease
(4) The patient with serious liver dysfunction, serious renal dysfunction, or dysuria
(5) In addition, the patient whom a study person in charge judged to be inadequate as subjects

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Tohru Shiga

Organization

Hokkaido University, Graduate School of Medicine

Division name

Department of Nuclear Medicine

Zip code

Address

N15,W7,Kita-Ku, Sapporo

TEL

011-706-5152

Email

tshiga@hokudai.ac.jp

Name of contact person

1st name
Middle name
Last name	Tohru Shiga

Organization

Hokkaido University, Graduate School of Medicine

Division name

Department of Nuclear Medicine

Zip code

Address

N15,W7,Kita-Ku, Sapporo

TEL

011-706-5152

Homepage URL

Email

kakui-s@med.hokudai.ac.jp

Institute

Hokkaido University Hospital

Institute

Department

Personal name

Organization

Self-procurement

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

04

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Date of protocol fixation

2015

Year

12

Month

22

Day

Date of IRB

Anticipated trial start date

2016

Year

04

Month

22

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

04

Month

01

Day

Last modified on

2016

Year

06

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025067