|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000021218 |
|
Date of registration:
|
26/02/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Evaluation of iron chelator administration, and cochlear implantation for s uperficial siderosis (ECHACISS)
|
|
Scientific title:
|
Evaluation of iron chelator administration, and cochlear implantation for s uperficial siderosis (ECHACISS) - ECHACISS |
|
Date of first enrolment:
|
2024/09/30 |
|
Target sample size:
|
5 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024471 |
|
Study type:
|
Interventional |
|
Study design:
|
Single arm Non-randomized
|
|
Phase:
|
Not applicable
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Nobuo
Sanjo |
|
Address:
|
1-5-45, Yushima, Bunkyo-ku, Tokyo
Japan |
|
Telephone:
|
03-5803-5234 |
|
Email:
|
n-sanjo.nuro@tmd.ac.jp |
|
Affiliation:
|
Tokyo Medical and Dental University Hospial Department of Neurology and Neurological Science |
|
|
Name:
|
same
same |
|
Address:
|
same
same
Japan |
|
Telephone:
|
03-5803-5234 |
|
Email:
|
n-sanjo.nuro@tmd.ac.jp |
|
Affiliation:
|
same same |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: anaphylaxis to iron chelator patients receiving any drug having side effect of leukopenia pregnant person claustrophobia inadequate patients
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
superficial siderosis of CNS
|
|
Intervention(s)
|
|
deferiprone administration cochlear implantation
|
|
Primary Outcome(s)
|
|
hearing ability, cerebellar ataxia (SARA, ICARS), MRI findings, pyramidal sign, electrophysiological studies
|
|
Secondary Outcome(s)
|
|
persistence rate of treatment, CSF findings, safety
|
|
Source(s) of Monetary Support
|
|
none
|
|
Ethics review
|
Status: YES
Approval date: 11/03/2019
Contact:
n-sanjo.nuro@tmd.ac.jp
Tokyo Medical and Dental University
03-3813-6111
n-sanjo.nuro@tmd.ac.jp
|
|