UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022969 |
|---|---|
| Receipt number | 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 15:16:47 |
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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
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
kesugi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026479
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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