UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
Title of the study (Brief title)	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	Yasusi Shimo
Organization	Juntendo University Hospital
Division name	Department of Neurology
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-3111
Email	yshimo@juntendo.ac.jp

Public contact
Name of contact person	Sasaki Fuyuko
Organization	Juntendo University Hospital
Division name	Department of Neurology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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