UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005610 |
|---|---|
| Receipt number | R000006608 |
| Scientific Title | Clinical study for efficacy of the deep brain stimulation for the Tourette Syndrome with severe involuntary movement |
| Date of disclosure of the study information | 2011/05/20 |
| Last modified on | 2013/11/23 12:30:25 |
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Basic information
Public title
Clinical study for efficacy of the deep brain stimulation for the Tourette Syndrome with severe involuntary movement
Acronym
The deep brain stimulation for the Tourette Syndrome with severe involuntary movement
Scientific Title
Clinical study for efficacy of the deep brain stimulation for the Tourette Syndrome with severe involuntary movement
Scientific Title:Acronym
The deep brain stimulation for the Tourette Syndrome with severe involuntary movement
Region
| Japan |
Condition
Condition
Tourette Syndrome
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine that deep brain stimulation improves the involuntary movement of the patients with Tourette Syndrome and does not affect the cognitive and emotional function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Yale Global Tic Severity Scale
Key secondary outcomes
modified Rush video-based protocol and rating scale (mRVRS), Short-Form 36-Item Health Survey (SF-36), WAIS-III, WMS-R, BDI-II, MMPI
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
| Maneuver |
Interventions/Control_1
Deep Brain Stimulation group
Interventions/Control_2
Sham Deep Brain Stimulation
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
to have Informed consent
Tourette Syndrome with YGTSS 35 < /50
17 years old <
Refractory patients with medication and psychotherapy for more than 6 months and no tolerant patients with medication
Key exclusion criteria
The patients with severe cardiac disease, Respiratory failure, epilepsy, severe head injury, cerebral vascular accident, autism, schizophrenia, manic-deprresive psychosis, gravida
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasukazu Kajita |
Organization
Nagoya University, Postgraduate School of Medicine
Division name
Neurosurgery
Zip code
Address
65 Tsurumai Syouwa, Nagoya
TEL
052-744-2353
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasukazu Kajita |
Organization
Nagoya University, Postgraduate School of Medicine
Division name
Neurosurgery
Zip code
Address
65 Tsurumai Syouwa, Nagoya
TEL
052-744-2353
Homepage URL
ykajita@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University, Postgraduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University, Postgraduate School of Medicine
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 05 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | 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
| 2011 | Year | 05 | Month | 17 | Day |
Last modified on
| 2013 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006608
