UMIN-CTR Clinical Trial

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
Last 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
Email	jnaru@koto.kpu-m.ac.jp

Public contact
1st 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
Email	yuki1209@koto.kpu-m.ac.jp

Sponsor
Institute	Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015204