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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001576
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of neurology, Fukushima medical university
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001899

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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