UMIN-CTR Clinical Trial

Basic information
Public title	Development of Brain Machine Interface using deep brain electrode
Acronym	Development of Brain Machine Interface using deep brain electrode
Scientific Title	Development of Brain Machine Interface using deep brain electrode
Scientific Title:Acronym	Development of Brain Machine Interface using deep brain electrode
Region	Japan

Condition
Condition	Movement disorders
Classification by specialty	Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Discrimination rates for motor type, emotion, and intention
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Parkinson's disease patients who have been or will be implanted with a implantable pulse generator capable of extracting local field potential Sufficient motor and cognitive function to perform motor and cognitive tasks
Key exclusion criteria	Patients with declining cognitive function Patients who have difficulty communicating
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Haruhiko Middle name Last name Kishima
Organization	Osaka University Graduate School of Medicine
Division name	Department of Neurosurgery
Zip code	5650871
Address	2-2 Yamadaoka, Suita City, Osaka, Japan
TEL	+81-(6)-6879-3652
Email	n-tani@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Naoki Middle name Last name Tani
Organization	Osaka University Graduate School of Medicine
Division name	Department of Neurosurgery
Zip code	5650871
Address	2-2 Yamadaoka, Suita City, Osaka, Japan
TEL	+81-(6)-6879-3652
Homepage URL
Email	n-tani@nsurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Otemae Hospital Osaka General Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-2 Yamadaoka, Suita City, Osaka, Japan
Tel	+81-6-6210-8292
Email	rinri@hp-crc.med.osaka-u.ac.jp

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	大阪大学大学院医学系研究科脳神経外科

Other administrative information
Date of disclosure of the study information	2021 Year 09 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	Enrolling by invitation
Date of protocol fixation	2021 Year 06 Month 07 Day
Date of IRB	2021 Year 08 Month 31 Day
Anticipated trial start date	2021 Year 09 Month 01 Day
Last follow-up date	2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Non-randomized non-blinded prospective case series study

Management information
Registered date	2021 Year 06 Month 07 Day
Last modified on	2022 Year 06 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050789