UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010539 |
|---|---|
| Receipt number | R000012322 |
| Scientific Title | Low frequency repetitive transcranial magnetic stimulation in the treatment of svere Tourette's syndrome |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2019/04/23 20:50:35 |
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Basic information
Public title
Low frequency repetitive transcranial magnetic stimulation in the treatment of svere Tourette's syndrome
Acronym
rTMS therapy for Tourette's syndrome
Scientific Title
Low frequency repetitive transcranial magnetic stimulation in the treatment of svere Tourette's syndrome
Scientific Title:Acronym
rTMS therapy for Tourette's syndrome
Region
| Japan |
Condition
Condition
Tourette's syndrome
Classification by specialty
| Neurology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical evaluation for the efficacy of low frequency transcranial magnetic stimulation for patients with severe Tourette's syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Yale Global Tic Severity Scale (YGTSS)
Key secondary outcomes
Hamilton Depression Rating Scale
Hamilton Anxiety Rating Scale
Social-Adaptation Self-evaluation Scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
low frequency transcranial magnetic stimulation
Interventions/Control_2
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
eMedically intractable patients with Tourette's syndrome who have more than 60/100 scores of Yale Global Tic Severity Scale (YGTSS)
Key exclusion criteria
Patients with psychiatric disease
Patients with intracranial magnetic particles
Patients with cardiac pacemaker or vagas nerve stimulation
Patients with epilepsy
Pregnant patients
Patients with acoustic duct
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Shiraishi |
Organization
Hokkaido University Hospital
Division name
Department of Pediatrics
Zip code
060-8648
Address
North 14, West 5, Kita-ku, Sapporo, Japan
TEL
011-706-5954
siraisi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Shiraishi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, Japan
TEL
011-706-5954
Homepage URL
siraisi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Clinical Research Review
Address
North 14, West 5, Kitaku, Sapporo
Tel
011-706-7934
recjimu@huhp.hokudai.ac.jp
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 18 | Day |
Last modified on
| 2019 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012322
