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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022969
Receipt No. R000026479
Scientific Title Deep brain stimulation(DBS) for intractable obsessive-compulsive disorders(OCDs). randomized crossover trial and open-label trial
Date of disclosure of the study information 2016/07/07
Last modified on 2016/07/01

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Basic information
Public title Deep brain stimulation(DBS) for intractable obsessive-compulsive disorders(OCDs).
randomized crossover trial and open-label trial
Acronym Deep brain stimulation for intractable obsessive-compulsive disorders (DBS for OCDs)
Scientific Title Deep brain stimulation(DBS) for intractable obsessive-compulsive disorders(OCDs).
randomized crossover trial and open-label trial
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Kenji Sugiyama
Organization Hamamatsu University School of Medicine
Division name Department of Neurosurgery
Zip code
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
1st name
Middle name
Last name Kenji Sugiyama
Organization Hamamatsu University School of Medicine
Division name Department of Neurosurgery
Zip code
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

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)

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
2016 Year 07 Month 07 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 Preinitiation
Date of protocol fixation
2015 Year 11 Month 16 Day
Date of IRB
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

Other
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

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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