UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Detection of impaired neural circuits in central nervous system diseases and development of neurophysiological biomarkers for functional brain network abnormalities
Title of the study (Brief title)	Detection of impaired neural circuits in central nervous system diseases
Region	Japan

Condition
Condition	cerebrovascular disease, Parkinson's syndrome, essential tremor and epilepsy
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to detect impaired neural circuits and develop neurophysiological biomarkers for cerebrovascular disease, Parkinson's syndrome, essential tremor and epilepsy, analyzing MRI data and signals of magnetoencephalography and intracranial electrodes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	functional brain networks analyzed using MRI data and signals of magnetoencephalography and intracranial electrodes.
Key secondary outcomes	clinical assessment battery for each disease

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	idiopathic Parkinson's disease, essential tremor, acute stroke, normal control
Key exclusion criteria	none
Target sample size	60

Research contact person
Name of lead principal investigator	Haruhiko Kishima
Organization	Osaka university graduate school of medicine
Division name	Department of neurosurgery
Address	Yamadaoka 2-2, Suita, Osaka
TEL	06-6879-3652
Email	hkishima@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Haruhiko Kishima
Organization	Osaka university graduate school of medicine
Division name	Department of neurosurgery
Address	Yamadaoka 2-2, Suita, Osaka
TEL	06-6879-3652
Homepage URL
Email	hkishima@nsurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka university
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Japan agency for medical research and development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 30 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 06 Month 17 Day
Anticipated trial start date	2015 Year 06 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Estimating current sources from the brain magnetic field signals, and analyzing the power and functional connectivity for each frequency band.

Management information
Registered date	2016 Year 06 Month 30 Day
Last modified on	2016 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023404