UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013123 |
|---|---|
| Receipt number | R000015204 |
| Scientific Title | The development of treatment using the neurofeedback for patients with obsessive-compulsive disorder |
| Date of disclosure of the study information | 2014/02/17 |
| Last modified on | 2019/03/29 17:29:13 |
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Basic information
Public title
The development of treatment using the neurofeedback for patients with obsessive-compulsive disorder
Acronym
The development of treatment using the neurofeedback for patients with obsessive-compulsive disorder
Scientific Title
The development of treatment using the neurofeedback for patients with obsessive-compulsive disorder
Scientific Title:Acronym
The development of treatment using the neurofeedback for patients with obsessive-compulsive disorder
Region
| Japan |
Condition
Condition
Obsessve-compulsive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Devetopment of the novel treatment using neurofeedbach in patients with obsessive-compulsive disorder
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Yale-Brown Obsessive Compulsive Scale
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
The prefrontal cortex and the striatum is key brain structure in the pathophysiology of obsessive-compulsive disorder. We are planning to treat patients with obsessive-compulsive disorder through training the brain activity in these regions using neurofeedback.
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
We will recruit the patients with obsessive-compulsive disorder at the Kyoto Prefectural University of Medicine Hospital, Kyoto, Japan. Only patients who give written, informed consent after receiving a description of this study will take part.
Key exclusion criteria
The exclusion criteria for patients: 1) cardiac pacemakers or other metallic implants or artifacts; 2) significant disease, including neurological diseases, disorders of the pulmonary, cardiac, renal, hepatic, or endocrine systems, or metabolic disorders; 3) prior psychosurgery; 4) pregnancy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jin Narumoto |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5612
jnaru@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Sakai |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5612
Homepage URL
yuki1209@koto.kpu-m.ac.jp
Sponsor or person
Institute
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
the Strategic Research Program for Brain Sciences by the Ministry of Education, Culture, Sports, Science and Technology of Japan.
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 10 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015204
