UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029134 |
|---|---|
| Receipt number | R000033305 |
| Scientific Title | Interventional study for substances to reduce impedance at the pad/skin interface during electroconvulsive therapy |
| Date of disclosure of the study information | 2017/09/14 |
| Last modified on | 2019/02/21 17:18:12 |
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Basic information
Public title
Interventional study for substances to reduce impedance at the pad/skin interface during electroconvulsive therapy
Acronym
Interventional study for substances to reduce impedance at the pad/skin interface during electroconvulsive therapy
Scientific Title
Interventional study for substances to reduce impedance at the pad/skin interface during electroconvulsive therapy
Scientific Title:Acronym
Interventional study for substances to reduce impedance at the pad/skin interface during electroconvulsive therapy
Region
| Japan |
Condition
Condition
According to the diagnostic criteria for mood (affective) disorders:ICD-10
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of impedance-reduction between PreTac(skin preparatory solution to remove sebum) and Grad Z-101BA(salt-infused gel applied between electric pad and skin).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Static impedance (measured with 6 microampere) at placing electrodes on the patient skin and dynamic impedance (measured with 0.9 ampere) during administrating electric current to the brain.
Key secondary outcomes
Number of times spent with saimapad
and Postictal Suppression Index (decrease in value immediately after the attack, completed average amplitude of 3 seconds between viewed in percent as reduced the average amplitude of the maximum amplitude of the seizure during 3 seconds, which one of the indicators of the quality of the attack)
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 |
Interventions/Control_1
Installing using drugs used saimapad in modified electroconvulsive therapy in the study subjects 10.
The modified electroconvulsive therapy and other enforcement procedures there is no difference.
(1) odd times:PreTac liquid
(2) even once: Grad Z-101BA
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
Study participants shall meet all the following criteria.
(1)Persons diagnosed with F3 mood (affective) disorders ICD-10 diagnostic criteria using
(2)Persons wearing saimapad on the bilateral side head, carried a modified electroconvulsive therapy
(3)Agree to the proposed person or obtained from the Novotel (spouse, brothers and sisters, his lineal relative within the relatives, guardian or curator shall)
Key exclusion criteria
Otherwise excluded from study participants.
(1) if the person or from the Novotel was discontinued participation in research proposal
(2) in the PreTac fluid and Gerad Z-101BA until now or further if any allergic symptoms
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Miyaoka |
Organization
Kitasato University East hospital
Division name
Department of Psychiatry
Zip code
Address
2-1-1 Asamizodai,Minami-ku, Sagamihara-shi, Kanagawa 252-0380, Japan
TEL
042-748-9111
miyaoka@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoya Shimano |
Organization
Kitasato University East hospital
Division name
Department of Psychiatry
Zip code
Address
2-1-1 Asamizodai,Minami-ku, Sagamihara-shi, Kanagawa 252-0380, Japan
TEL
042-748-9111
Homepage URL
dm17013@st.kitasato-u.ac.jp
Sponsor or person
Institute
Department of Pychiatry, Kitasato University East hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Pychiatry, Kitasato University East hospital
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
Address
Tel
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
北里大学東病院（神奈川県）/ Kitasato University East hospital (Kanagawa Prefecture
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 14 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 21 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 21 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 21 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 13 | Day |
Last modified on
| 2019 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033305
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
