UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010523 |
|---|---|
| Receipt number | R000012302 |
| Scientific Title | The efficacy of repetitive transcranial magnetic stimulation over the several sites of brain in treatment of Parkinsonism. |
| Date of disclosure of the study information | 2013/04/17 |
| Last modified on | 2016/04/18 14:58:59 |
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Basic information
Public title
The efficacy of repetitive transcranial magnetic stimulation over the several sites of brain in treatment of Parkinsonism.
Acronym
The efficacy of repetitive transcranial magnetic stimulation over the several sites of brain in treatment of Parkinsonism.
Scientific Title
The efficacy of repetitive transcranial magnetic stimulation over the several sites of brain in treatment of Parkinsonism.
Scientific Title:Acronym
The efficacy of repetitive transcranial magnetic stimulation over the several sites of brain in treatment of Parkinsonism.
Region
| Japan |
Condition
Condition
Parkinsonism
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of repetitive transcranial magnetic stimulation over the primary motor area and the supplementary motor area, the dorsolateral prefrontal cortex for Parkinsonism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Unified Parkinson's Disease Rating Scale(UPDRS),Parkinson's Disease Questionnaire-39(PDQ-39)
Key secondary outcomes
5-point scale for daily life and tremor, Apathy scale,Montogomery and Asberg depression rating scale,Self-rating Depression Scale(SDS),analyzed parameters of finger tapping by magnetic sensor,Timed up and go test
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
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Repetitive transcranial magnetic stimulation over the primary motor area
Interventions/Control_2
Repetitive transcranial magnetic stimulation over the supplementary motor area
Interventions/Control_3
Repetitive transcranial magnetic stimulation over the DLPFC
Interventions/Control_4
Sham stimulation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Diagnosed as Parkinsonism
(2)Patients who consented to keep drug and living conditions during the study
(3) No cognitive disorders, aphasia, psychiatric disorder, higher brain dysfunction
(4) the patients who can write questionare
(5) over 20 years old
(6) Those who give us informed consent to participate in the present study after detailed explanation of the study
Key exclusion criteria
(1) No implantation of metal in head, except in the mouth
(2) Those having heart pacemaker or drug infusion pomp
(3) Those having heart pacemaker or severe heart diseases
(4) Those having the deep brain stimulation or the spinal cord stimulation
(5)Major cerebral infarction, head traum, epilepsy, brain tumor
(6) Pregnant or intend to be pregnant
(7) the patients who are excluded by doctors
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Yokoe |
Organization
Osaka university
Division name
Department of Neuromodulation and Neurosurgery,Office forUniversity-Industry Collaboration
Zip code
Address
2-1 Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3571
neurosaitoh@mbk.nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Yokoe |
Organization
Osaka university
Division name
Department of Neuromodulation and Neurosurgery,Office forUniversity-Industry Collaboration
Zip code
Address
2-1 Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3571
Homepage URL
myokoe@neurol.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University, Department of Neuromodulation and Neurosurgery,Office forUniversity-Industry Collaboration
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2013 | Year | 04 | Month | 17 | 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
Suspended
Date of protocol fixation
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 17 | Day |
Last modified on
| 2016 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012302
