UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001576 |
|---|---|
| Receipt number | R000001899 |
| Scientific Title | A randomized, double-blind, placebo- controlled, multi-center, parallel study concerning the efficacy of repetitive transcranial magnetic stimulation over the supplementary motor area in treatment of motor and non- motor symptoms in Parkinson's disease |
| Date of disclosure of the study information | 2008/12/17 |
| Last modified on | 2011/08/02 13:02:55 |
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Basic information
Public title
A randomized, double-blind, placebo- controlled, multi-center, parallel study concerning the efficacy of repetitive transcranial magnetic stimulation over the supplementary motor area in treatment of motor and non- motor symptoms in Parkinson's disease
Acronym
The efficacy of repetitive transcranial magnetic stimulation over the supplementary motor area in treatment of Parkinson's disease.
Scientific Title
A randomized, double-blind, placebo- controlled, multi-center, parallel study concerning the efficacy of repetitive transcranial magnetic stimulation over the supplementary motor area in treatment of motor and non- motor symptoms in Parkinson's disease
Scientific Title:Acronym
The efficacy of repetitive transcranial magnetic stimulation over the supplementary motor area in treatment of Parkinson's disease.
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of repetitive transcranial magnetic stimulation over the supplementary motor area for Parkinson's disease
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) part 3
Key secondary outcomes
UPDRS part 1,2,4, 5-point scale for daily life and tremor, Apathy scale, 17 item of Hamilton depression scale, Non-Motor Symptoms Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Repetitive transcranial magnetic stimulation over the supplementary motor area, high-frequency stimulation
Interventions/Control_2
Repetitive transcranial magnetic stimulation over the supplementary motor area, low-frequency stimulation
Interventions/Control_3
Sham stimulation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Diagnosed as Parkinson's disease (PD) according to the UK Parkinson's disease Society brain bank 2) Patients who are capable of ambulatory hospital visits 3)Patients who consented to keep drug and living conditions during the study. 4)Patients who were rated as Hoehn-Yahr grade 2 or 3 or 4. 5) Those who give us informed consent to participate in the present study after detailed explanation of the study
Key exclusion criteria
1)The patients who underwent the TMS treatment before 2)No implantation of metal in head, except in the mouth 3) Those having heart pacemaker or drug infusion pomp 4) Serious heart disease 5)History of massive cerebral infarction, head injury, brain tumor, or epilepsy 6)Pregnant or intend to be pregnant
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Ugawa |
Organization
Fukushima medical university
Division name
Department of neurology
Zip code
Address
1, Hikarigaoka, Fukushima, 960-1295, Japan
TEL
024-547-1246
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Enomoto |
Organization
Fukushima medical university
Division name
Department of neurology
Zip code
Address
1, Hikarigaoka, Fukushima, 960-1295, Japan
TEL
024-547-1248
Homepage URL
Sponsor or person
Institute
Department of neurology, Fukushima medical university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Univ: Occupational Environ Health,Tokushima,Kyusyu,Tottori,Tokyo,Hokkaido,Saitama Med,Osaka, Hamamatsu Med,Kinki)
Tokyo neurological hos,Kumamoto Kinoh hos, Nagasaki Med center of Neurol
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
| 2008 | Year | 12 | 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
Completed
Date of protocol fixation
| 2008 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 15 | Day |
Last modified on
| 2011 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001899
