UMIN-CTR Clinical Trial

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

Parkinson's disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Department of Neurology, Juntendo University Hospital

Institute

Department

Personal name

Organization

Boston Scientific Corporation
Neuromodulation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

10

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

10

Month

05

Day

Last modified on

2019

Year

01

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027861