UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015803 |
|---|---|
| Receipt number | R000018387 |
| Scientific Title | Research on musical hallucination with hearing difficulty and cerebrovascular disorder |
| Date of disclosure of the study information | 2014/12/08 |
| Last modified on | 2020/06/25 15:36:29 |
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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
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
02181984@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences Department of Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018387
