UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Deep brain stimulation(DBS) for intractable obsessive-compulsive disorders(OCDs). randomized crossover trial and open-label trial
Title of the study (Brief title)	Deep brain stimulation for intractable obsessive-compulsive disorders (DBS for OCDs)
Region	Japan

Condition
Condition	Intractable obsessive-compulsive disorders
Classification by specialty	Psychiatry Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Observe the efficacy of DBS of the bilateral anterior internal capsule/ ventral striatum (AIC/VS-DBS) for intractable OCDs
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	more than 35% improvement of Yale Brown Obsessive Compulsive Scale (Y-BOCS) at 12 months after the initiation of AIC/VS-DBS.
Key secondary outcomes

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Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Deep brain stimulation group
Interventions/Control_2	Sham deep brain stimulation group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	20 to 70 year-old OCD patients diagnosed by DSM-5 with the informed consent. Y-BOCS score of 30/40 or more and Global Assessment of Functioning scores of 45 or less. Refractory against medication and cognitive behavioral therapy for more than 5 years.
Key exclusion criteria	Other psychiatric illness (autism, schizophrenia, bipolar disorders, depression, drug addiction), and brain disease (epilepsy, trauma, cerebro-vascular disease, neuro-degenerative disease) except tic and Tourette syndrome. Severe cardiac diseases, pulmonary diseases blood diseases Pregnant or during breast-feeding. Whom researchers judged as inappropriate
Target sample size	20

Research contact person
Name of lead principal investigator	Kenji Sugiyama
Organization	Hamamatsu University School of Medicine
Division name	Department of Neurosurgery
Address	1-20-1, Handa-yama, Higashi-ku, Hamamatsu
TEL	053-435-2283
Email	kesugi@hama-med.ac.jp

Public contact
Name of contact person	Kenji Sugiyama
Organization	Hamamatsu University School of Medicine
Division name	Department of Neurosurgery
Address	1-20-1, Handa-yama, Higashi-ku, Hamamatsu
TEL	053-435-2283
Homepage URL
Email	kesugi@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2016 Year 07 Month 07 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 11 Month 16 Day
Anticipated trial start date	2016 Year 07 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 01 Day
Last modified on	2016 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026479