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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028148
Receipt No. R000032218
Scientific Title The development of treatment using decoded neurofeedback for patients with PTSD
Date of disclosure of the study information 2017/07/15
Last modified on 2019/07/11

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Basic information
Public title The development of treatment using decoded neurofeedback for patients with PTSD
Acronym The development of treatment using decoded neurofeedback for patients with PTSD
Scientific Title The development of treatment using decoded neurofeedback for patients with PTSD
Scientific Title:Acronym The development of treatment using decoded neurofeedback for patients with PTSD
Region
Japan

Condition
Condition Post-traumatic stress disorder (PTSD)
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A main purpose of this clinical trial is to evaluate safety and efficacy of fMRI neurofeedback applied to PTSD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Clinician-Administered PTSD scale
Key secondary outcomes Skin conductance response to traumatic stimuli
Amygdala response to traumatic stimuli

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
Device,equipment
Interventions/Control_1 fMRI neurofeedback using a 3T fMRI apparatus
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
20 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria 1. DSM-IV-TR diagnosis of PTSD
2. Normal visual acuity
4. Aged 20-50 years-old, outpatients,
5. Capability of informed consent
Key exclusion criteria Implanted cardiac pacemaker
Surgical aneurysm clips
Neurostimulator
Implanted pumps
Metal fragments in body/eyes
Tattoos or permanent eyeliner (if ink contains metallic specks)
Treatment history of ECT
Diagnosis of neurological disorders (including epilepsy), substance dependence, or
significant cardiac disease
History of neurological disorders (including epilepsy), substance dependence, or head injury with loss of consciousness
Pregnancy. Suspicion of pregnancy. Breast-feeding. Incapability of contraception during experiment. Doctors diagnose danger.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Yoneda
Organization Osaka Medical College
Division name Neuropsychiatry
Zip code 569-8686
Address 2-7 Daigaku-machi, Takatsuki-city, Osaka, Japan
TEL 072-683-1221
Email psy044@osaka-med.ac.jp

Public contact
Name of contact person
1st name Tetsufumi
Middle name
Last name Kanazawa
Organization Osaka Medical College
Division name Neuropsychiatry
Zip code 569-8686
Address 2-7 Daigaku-machi, Takatsuki-city, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email psy052@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Advanced Telecommunications Research Institute International (ATR)
National defense medical college
Japan ground self-force, Test and evaluation command, Military Medicine Research Unit
Self-Defense Forces Central Hospital
Kobe University
Hyogo Institute for Traumatic Stress
Akasaka clinic
Kokoro to Karada Hikarinohana clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka Medical College
Address 2-7 Daigaku-machi, Takatsuki-city, Osaka, Japan
Tel 072-683-1221
Email psy052@osaka-med.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
2017 Year 07 Month 15 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
2017 Year 06 Month 01 Day
Date of IRB
2017 Year 07 Month 03 Day
Anticipated trial start date
2017 Year 07 Month 20 Day
Last follow-up date
2027 Year 07 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 09 Day
Last modified on
2019 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032218

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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