UMIN-CTR Clinical Trial

Basic information
Public title	Research on musical hallucination with hearing difficulty and cerebrovascular disorder
Acronym	Research on musical hallucination with hearing difficulty and cerebrovascular disorder
Scientific Title	Research on musical hallucination with hearing difficulty and cerebrovascular disorder
Scientific Title:Acronym	Research on musical hallucination with hearing difficulty and cerebrovascular disorder
Region	Japan

Condition
Condition	Organic hallucinosis
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To identify antiepleptics effects of musical hallucination and the responsible brain region of the symptom.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification of responsible brain region of musical hallucination.
Key secondary outcomes	1)The degree of auditory hallucination(Auditory Hallucination Rating Scale) 2) The Relationship between musical hallucination and dominant hemisphere.(Chapman and Chapman handedness test, Edinburgh inventory, f-MRI)

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	Medicine Gene
Interventions/Control_1	To administer antiepileptics
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) Musical hallucination 2) Hearing difficulty 3) Cerebrovascular disorder
Key exclusion criteria	Severe mental illness and dementia
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Hitoshi Middle name Last name Sakimoto
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Psychiatry
Zip code	890-8520
Address	35-1 8-chome, Sakuragaoka, kagoshimashi, kagoshima, 890-8520, Japan
TEL	099-275-5346
Email	02181984@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	1st name Hitoshi Middle name Last name Sakimoto
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Department of Psychiatry
Zip code	890-8520
Address	35-1 8-chome, Sakuragaoka, kagoshimashi, kagoshima, 890-8520, Japan
TEL	099-275-5346
Homepage URL
Email	02181984@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University Graduate School of Medical and Dental Sciences Department of Psychiatry
Institute
Department

Funding Source
Organization	none
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	Institutional Review Board of Kagoshima University Hospital
Address	-1 8-chome, Sakuragaoka, kagoshimashi, kagoshima, 890-8520, Japan
Tel	099-275-6692
Email	kufsyomu@kuas.kagoshima-u.ac.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	2014 Year 12 Month 08 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	2014 Year 12 Month 01 Day
Date of IRB	2013 Year 09 Month 13 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2021 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 12 Month 01 Day
Last modified on	2020 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018387