UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028148 |
|---|---|
| Receipt number | 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 | 2023/05/09 05:53:26 |
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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 | Tetsufumi |
| Middle name | |
| Last name | Kanazawa |
Organization
Osaka Medical and Pharmaceutical University
Division name
Neuropsychiatry
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki-city, Osaka, Japan
TEL
072-683-1221
tk@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Tetsufumi |
| Middle name | |
| Last name | Kanazawa |
Organization
Osaka Medical and Pharmaceutical University
Division name
Neuropsychiatry
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki-city, Osaka, Japan
TEL
072-683-1221
Homepage URL
tk@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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
Kokoro to Karada Hikarinohana clinic
Seven mental clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical College
Address
2-7 Daigaku-machi, Takatsuki-city, Osaka, Japan
Tel
072-683-1221
rinri@ompu.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
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032218
| 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 |
