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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005361
Receipt No. R000005925
Scientific Title A cohort study concerning the efficacy of chronic deep brain stimulation in treatment of back pain in advanced Parkinson's disease
Date of disclosure of the study information 2011/04/01
Last modified on 2012/10/15

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Basic information
Public title A cohort study concerning the efficacy of chronic deep brain stimulation in treatment of back pain in advanced Parkinson's disease
Acronym Efficacy of deep brain stimulation on back pain in Parkinson's disease
Scientific Title A cohort study concerning the efficacy of chronic deep brain stimulation in treatment of back pain in advanced Parkinson's disease
Scientific Title:Acronym Efficacy of deep brain stimulation on back pain in Parkinson's disease
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy of deep brain stimulation on back pain in Parkinson's disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Visual analogue pain scale
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Advanced idiopathic PD is diagnosed in all patients and refer to us by neurologists with an intimate knowledge of the pharmacological treatment of PD. Our surgical indication criteria for STN stimulation is clinically diagnosed advanced idiopathic PD which demonstrate evidence of a good response to levodopa, and a Hoehn and Yahr staging that is within the range of stages III-V during the off-period and stage III or less in the best on-condition despite treatment with optimal pharmacological therapies.
Key exclusion criteria Patients with major depression or cognitive dysfunction (Mini-Mental Status Examination score < 24) are excluded as candidates for surgery.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Oshima
Organization Nihon University, School of Medicine
Division name Neurological Surgery
Zip code
Address 30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Oshima
Organization Nihon University, School of Medicine
Division name Neurological Surgery
Zip code
Address
TEL 03-3972-8111
Homepage URL
Email ooshima.hideki@nihon-u.ac.jp

Sponsor
Institute Nihon University, School of Medicine
Institute
Department

Funding Source
Organization None
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
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 日本大学医学部附属板橋病院(東京)

Other administrative information
Date of disclosure of the study information
2011 Year 04 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
2009 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2012 Year 07 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 31 Day
Date trial data considered complete
2012 Year 12 Month 31 Day
Date analysis concluded
2012 Year 12 Month 31 Day

Other
Other related information cohort study

Management information
Registered date
2011 Year 04 Month 01 Day
Last modified on
2012 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005925

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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