UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research on brain machine interfaces for motor and communication control
Acronym	Clinical research on motor and communication BMIs
Scientific Title	Clinical research on brain machine interfaces for motor and communication control
Scientific Title:Acronym	Clinical research on motor and communication BMIs
Region	Japan

Condition
Condition	ALS, SMA
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate safety and efficacy of a wired BMI device for motor and communication control using temporarily placed brain surface grid electrodes in severe ALS or SMA patients. This contributes to chronic implantation of a fully-implantable wireless device.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Safety of implantable devices
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Implantation of brain surface electrodes
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	1) severe ALS or SMA 2) patients under artificial respiration control 3) older than 20years old 4) Informed consent is available from the patient himself by orally or verbally
Key exclusion criteria	1) severe brain lesion 2) severe functional abnormality by EEG or MEG 3) impassible to manipulate the device in the present study due to severe visualor auditory disturbance 4) severe disturbance in heart, lung, liver, kidney, cognitive function, or psychological function 5) malignancy 6) compromised patient 7) bleeding tendency 8) taking steroids or immunosuppressive agents 9) taking anticoagulant drugs 10) severe underlying diseases other than targer illness 11) inappropriate to participate
Target sample size	3

Research contact person
Name of lead principal investigator	1st name Toshiki Middle name Last name Yoshimine
Organization	Osaka Univerisity Graduate School of Medicine
Division name	Department of Neurosurgery
Zip code	565-0871
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3652
Email	mhirata@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Masayuki Middle name Last name Hirata
Organization	Osaka Univerisity Graduate School of Medicine
Division name	Department of Neurosurgery
Zip code	565-0871
Address	2-2 Yamadaoka, Suita
TEL	06-6879-3652
Homepage URL
Email	mhirata@nsurg.med.osaka-u.ac.jp

Sponsor
Institute	Department of neurosurgery, Osaka University Meidical Shchool
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Hopital
Address	2-2 Yamadaoka, Suita-Shi, Osaka 565-0871, Japan
Tel	0662108289
Email	soudan@dmi.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

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 09 Day

Related information
URL releasing protocol	https://www.jstage.jst.go.jp/article/clinicalneurol/53/11/53_1405/_article/-char/ja/
Publication of results	Published

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/clinicalneurol/53/11/53_1405/_article/-char/ja/
Number of participants that the trial has enrolled	1
Results	One patient participated in this study. He underwent the placement of ECoG electrodes and we evaluated the safety and efficacy of motor and communication control of wired BM. We obtained sufficient information from the patient.
Results date posted	2022 Year 02 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	ALS
Participant flow	IC-pre-registration-screening tests-IC-registration-electrode placement-evaluation-electrode removal
Adverse events	subdural hematoma
Outcome measures	robot hand control communication control
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 10 Day
Date of IRB	2012 Year 10 Month 10 Day
Anticipated trial start date	2012 Year 10 Month 22 Day
Last follow-up date	2014 Year 10 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 04 Month 06 Day
Last modified on	2022 Year 02 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009045