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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024301
Receipt No. R000027861
Scientific Title Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
Date of disclosure of the study information 2016/10/07
Last modified on 2019/01/28

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Basic information
Public title Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
Acronym CLOVER-DBS
Scientific Title Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
Scientific Title:Acronym CLOVER-DBS
Region
Japan

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

Objectives
Narrative objectives1 The primary objective of this study is to collect clinical feedback data using a quantitative, objective feedback method.
The exploratory objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods in an acute setting, both in terms of clinical outcomes and programming burden.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Data collected will be used to further development of a closed loop programming algorithm and to build a better understanding of clinical responses to stimulation.
Key secondary outcomes Difference in the amount of time to program and number of steps to program using the novel programming method as compared to the standard of care (SOC) programming method.
Difference in UPDRS-III scores obtained from novel method settings versus from SOC settings.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Novel programming method
Interventions/Control_2 Standard programming method
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 Implanted bilaterally in STN with a Vercise DBS system for Parkinson's disease for at least six months and programming optimized according to standard of care with no changes to settings for at least four weeks.
Diagnosis of bilateral idiopathic PD with the presence of bradykinesia.
UPDRS subset 3 score of more than 25 in the pre operative meds off state.
DBS must improve PD symptoms by more than 30% in the meds off state, as measured by UPDRS subset 3 score.
Willing and able to comply with all visits, including required travel, and with study related procedures.
Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Key exclusion criteria Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
Any current drug or alcohol abuse as determined by the investigator.
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.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasusi Shimo
Organization Juntendo University Hospital
Division name Department of Neurology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email yshimo@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sasaki Fuyuko
Organization Juntendo University Hospital
Division name Department of Neurology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email fsasaki@juntendo.ac.jp

Sponsor
Institute Department of Neurology, Juntendo University Hospital
Institute
Department

Funding Source
Organization Boston Scientific Corporation
Neuromodulation
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 07 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
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 05 Day
Last modified on
2019 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027861

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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