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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000028414 |
Receipt No. | R000032523 |
Scientific Title | Exploratory study on auditory evoked field in patients with auditory processing disorders |
Date of disclosure of the study information | 2017/07/27 |
Last modified on | 2018/06/11 |
Basic information | ||
Public title | Exploratory study on auditory evoked field in patients with auditory processing disorders | |
Acronym | Auditory evoked field in patients with auditory processing disorders | |
Scientific Title | Exploratory study on auditory evoked field in patients with auditory processing disorders | |
Scientific Title:Acronym | Auditory evoked field in patients with auditory processing disorders | |
Region |
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Condition | ||
Condition | auditory processing disorders | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To visualize the pathophysiology of auditory function in patients with auditory processing disorders using magnetoencephalography |
Basic objectives2 | Others |
Basic objectives -Others | Establishment of objective evaluation |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Others |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | latency of N100m |
Key secondary outcomes |
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 | Prevention | |
Type of intervention |
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Interventions/Control_1 | magnetoencephalography | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | a) age: 20 years old or older than 20 years, and younger than 40 years old
b)performance status = 0 |
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Key exclusion criteria | 1) Subjects using a pacemaker and/or an implantable defibrillator
2) Subjects with the metals in the body 3) Subjects with scotophobia and/or claustrophobia 4) Subjects with the possibility of the pregnancy 5) Subjects with extreme myopia 6) Subjects who wear clothing (e.g., heat technical centers) for the cold protection using the new material 7) Subjects whom researchers judged to be inappropriate |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tohoku University | ||||||
Division name | Graduate School of Biomedical Engineering | ||||||
Zip code | |||||||
Address | 1-1 Seiryo-machi, Aoba-ku, Sendai | ||||||
TEL | 022-717-7303 | ||||||
kawase@orl.med.tohoku.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tohoku University | ||||||
Division name | Graduate School of Biomedical Engineering | ||||||
Zip code | |||||||
Address | 1-1 Seiryo-machi, Aoba-ku, Sendai | ||||||
TEL | 022-717-7303 | ||||||
Homepage URL | |||||||
kawase@orl.med.tohoku.ac.jp |
Sponsor | |
Institute | Tohoku University |
Institute | |
Department |
Funding Source | |
Organization | the Ministry of Education, Culture, Sports, Science and Technology-Japan |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032523 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |