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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034919
Receipt No. R000039821
Scientific Title Effects of electric field treatment on psychophysiological functions
Date of disclosure of the study information 2018/11/17
Last modified on 2019/05/20

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Basic information
Public title Effects of electric field treatment on psychophysiological functions
Acronym Effects of electric field treatment on psychophysiological functions
Scientific Title Effects of electric field treatment on psychophysiological functions
Scientific Title:Acronym Effects of electric field treatment on psychophysiological functions
Region
Japan

Condition
Condition insomnia, depression, anxiety disorder, stress disorder, somatoform disorder
Classification by specialty
Psychosomatic Internal Medicine Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness of eletric field treament on insommina, psychiatric symptoms and autonomic dysregulations and its mechanism of action.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Biological scores based on electroencephalography and heart-rate variability measurements and psychological scores using questionnaires are evaluated before and after the electric field treatment.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 30kV High voltage electric field is treatded for 1 to 20 minutes.
Interventions/Control_2 No treatment
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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria The subjects suffering from depression, anxiety disorder, stress disorder, and somatoform disorder are included together with normal subjects who agreed to participate in the study.
Key exclusion criteria The subjects who experience uncomfortable psychosomatic changes during electric field treatment are excluded from the study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Toshikazu
Middle name
Last name Shinba
Organization Shizuoka Saiseikai General Hospital
Division name Department of Psychiatry
Zip code 422-8527
Address 1-1-1 Oshika, Suruga-ku, Shizuoka 422-8527, Japan
TEL 054-285-6171
Email t156591@siz.saiseikai.or.jp

Public contact
Name of contact person
1st name Toshikazu
Middle name
Last name Shinba
Organization Shizuoka Saiseikai General Hospital
Division name Department of Psychiatry
Zip code 422-8527
Address 1-1-1 Oshika, Suruga-ku, Shizuoka 422-8527,Japan
TEL 054-285-6171
Homepage URL
Email t156591@siz.saiseikai.or.jp

Sponsor
Institute Shizuoka Saiseikai General Hospital
Institute
Department

Funding Source
Organization No research fund
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shizuoka Saiseikai General Hospital Institutional Review Board
Address 1-1-1 Oshika, Suruga-ku, Shizuoka 422-8527, Japan
Tel 054-285-6171
Email t156591@siz.saiseikai.or.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
2018 Year 11 Month 17 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
2018 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 17 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039821

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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