UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002849 |
|---|---|
| Receipt number | R000003478 |
| Scientific Title | Multicentric double-blinded crossover randomized clinical trial of deep brain stimulation for intractable Tourette syndrome |
| Date of disclosure of the study information | 2009/12/05 |
| Last modified on | 2010/07/05 16:41:58 |
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Basic information
Public title
Multicentric double-blinded crossover randomized clinical trial of deep brain stimulation for intractable Tourette syndrome
Acronym
Crossover and randomization design of intractable Tourette syndrome after surgery (CARITAS) trial
Scientific Title
Multicentric double-blinded crossover randomized clinical trial of deep brain stimulation for intractable Tourette syndrome
Scientific Title:Acronym
Crossover and randomization design of intractable Tourette syndrome after surgery (CARITAS) trial
Region
| Japan |
Condition
Condition
Intractable Tourette syndrome
Classification by specialty
| Neurology | Pediatrics | Psychiatry |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the safety and efficacy of deep brain stimulation for Tourette syndrome on a multicentric double-blinded randomized crossover study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Yale Global Tic Severity Scale (YGTSS) tic score
Key secondary outcomes
modified Rush Video-Based Rating Scale (mRVRS)
YGTSS social impairment score
Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score
Short Form-36 (SF-36)
Gilles de la Tourette syndrome-specific health-related -QOL scale (GTS-QOL)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
A stereotactic operation is performed aided by functional software and computed tomography (CT) or magnetic resonance imaging (MRI). Two permanent quadripolar leads (model 3387, Medtronic) are implanted bilaterally under general anesthesia.
The pulse generators (Soletra, Medtronic) are also implanted bilaterally and attached to lead extensions at the same time.
The pulse generator is activated and neuroelectrical parameters were changed by an investigator.
Patients are randomized 1 month after DBS, and stimulation 'on' or 'off' is started in a double-blinded fashion 1 month more later.
Group A: 'On' for 3 months and 'off' for 3 months, then open-labeled 'on' for 6 months.
Interventions/Control_2
Group B: 'Off' for 3 months and 'on' for 3 months, then open-labeled 'on' for 6 months.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria are a diagnosis of TS as defined in the articles of the Tourette Syndrome Classification Study Group and in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revised (DSM-IV-TR), an age of 18 years or older, a Yale Global Tic Severity Scale17 (TGTSS) total tic severity score of 35/50 or more, an inadequate response to at least two dopamine receptor antagonists and other agents such as serotonergic drugs, antiepileptic drugs, and benzodiazepines, and inadequate response to any psychotherapy.
Key exclusion criteria
Exclusion criteria are a significant untreated structural brain lesion, a tic disorder due to other medical causes, no severe medical, neurological, psychiatric, or cognitive disorders that inordinately increase the risk (e.g., severe cardiovascular, pulmonary, or hematological disorders, epilepsy, a history of head injury, stroke, neurodegenerative disease, autism, schizophrenia, bipolar disorder, recent substance dependence, current pregnancy, and a recent history of suicide attempts).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taisuke Otsuki MD, PhD |
Organization
National Center Hospital of Neurology and Psychiatry, Japan
Division name
Department of Neurosurgery
Zip code
Address
Ogawahigashicho 4-1-1, Kodaira, Tokyo, 187-8551, Japan
TEL
+81-42-341-2711
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanobu Kaido |
Organization
National Center Hospital of Neurology and Psychiatry
Division name
Department of Neurosurgery
Zip code
Address
Ogawahigashicho 4-1-1, Kodaira, Tokyo, 187-8551, Japan
TEL
+81-42-341-2711
Homepage URL
kaido@ncnp.go.jp
Sponsor or person
Institute
Department of Neurosurgery, National Center Hospital of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kyoto Univ.
Kinki Univ.
Natl Ctr of Neurol and Psychiat
Univ. of Tokyo
Tokyo Metropolitan Neurological Hosp.
Tohoku Univ.
Nagoya Univ.
Nara Med. Univ.
Nihon Univ.
Hamamatsu Univ. School of Med.
Yamaguchi Univ.
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
京都大学医学部附属病院（京都府）
近畿大学医学部附属病院(大阪府)
国立精神・神経センター病院（東京都）
東京大学医学部附属病院（東京都）
東京都立神経病院（東京都）
東北大学医学部附属病院(宮城県)
名古屋大学医学部附属病院（愛知県）
奈良県立医科大学附属病院（奈良県）
日本大学医学部附属病院（東京都）
浜松医科大学附属病院（静岡県）
山口大学医学部附属病院(山口県)
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are forced to stop this research because the institutional review board of National Center of Neurology and Psychiatry had requested to change the design of the research.
Management information
Registered date
| 2009 | Year | 12 | Month | 05 | Day |
Last modified on
| 2010 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003478
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
