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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030460
Receipt No. R000034748
Scientific Title A 3D gait analysis after deep brain stimulation in Parkinson's disease
Date of disclosure of the study information 2017/12/19
Last modified on 2019/06/23

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Basic information
Public title A 3D gait analysis after deep brain stimulation in Parkinson's disease
Acronym 3DGA-DBS
Scientific Title A 3D gait analysis after deep brain stimulation in Parkinson's disease
Scientific Title:Acronym 3DGA-DBS
Region
Japan

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

Objectives
Narrative objectives1 To assess and explore the efficacy of deep brain stimulations with directional modes in Parkinson's disease using 3D gait analysis system
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Number of steps and time on 6m walking and Time up and go test after the steering of deep brain stimulation
Key secondary outcomes Gait parameters and side effect on 6m walking and Time up and go test using 3D gait analysis system after steering of deep brain stimulation and Unified Parkinson's disease rating scale partIII

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The setting of deep brain stimulation is set to 0 mA as a placebo control.
Interventions/Control_2 To change 31 patterns of deep brain stimulation settings
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

Not applicable
Gender Male and Female
Key inclusion criteria -Parkinson's disease patients who was implanted bilaterally in STN with a DBS system (Vercise PC DBS System) for at least 3 months and was determined optimized programming according to standard care for at least 4weeks. The second or third segment electrode from the bottom is selected for optimized programming contact. The direction at the directional mode (0 degree, 120 degree, 240 degree) which causes pyramidal sign was identified during screening.
-Diagnosed bilateral idiopathic Parkinson's disease
-Subjects with written informed consent by their own will
Key exclusion criteria -Any significant psychiatric problems including unrelated clinically significant depression
-Any current drug or alcohol abuse
-Any history of recurrent or unprovoked seizures.
-Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival less than 12 months.
-Subjects with "the 3rd grade: red patient" in "the grade of fall risk" of Juntendo University Hospital
-Subjects with large body frame expected not to be assisted by researchers in the case of their fall
-Subjects who was considered inappropriate to participate in this study by the researchers
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Genko Oyama
Organization Juntendo University Hospital
Division name Department of Neurology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8431, JAPAN
TEL +81-3-3813-3111
Email g_oyama@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Genko Oyama
Organization Juntendo University Hospital
Division name Department of Neurology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8431, JAPAN
TEL +81-3-3813-3111
Homepage URL
Email g_oyama@juntendo.ac.jp

Sponsor
Institute Juntendo University Hospital
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kao Corporation
Name of secondary funder(s) None

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 順天堂大学医学部附属順天堂医院(東京都)
Juntendo University Hospital(Tokyo)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 19 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 No longer recruiting
Date of protocol fixation
2017 Year 10 Month 23 Day
Date of IRB
2017 Year 10 Month 12 Day
Anticipated trial start date
2017 Year 12 Month 19 Day
Last follow-up date
2018 Year 09 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 19 Day
Last modified on
2019 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034748

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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