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Recruitment status Terminated
Unique ID issued by UMIN UMIN000002849
Receipt No. 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

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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
Email

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
Email kaido@ncnp.go.jp

Sponsor
Institute Department of Neurosurgery, National Center Hospital of Neurology and Psychiatry
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003478

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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