UMIN-CTR Clinical Trial

Basic information
Public title	development and effect verification of lower limb brain machine interface using EEG
Acronym	development and effect verification of lower limb brain machine interface using EEG
Scientific Title	development and effect verification of lower limb brain machine interface using EEG
Scientific Title:Acronym	development and effect verification of lower limb brain machine interface using EEG
Region	Japan

Condition
Condition	Acute and chronic stroke (Healthy subject)
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The existence of "plasticity of the brain" has been clarified in the field of neurological rehabilitation which has developed recently in order to recover voluntary movement ability lost by cerebral apoplexy. In order to draw out the plasticity of the brain effectively, it is important to make the motion intention and the feedback of the sensory stimulation coincide in time, that is, to move along the motion intention. However, the existing rehabilitation support equipment does not depend on the motion intention of the patient himself, and there are many cases in which the leg is moved passively. Though there are some devices which acquire the myoelectric potential and electroencephalogram to assist the movement according to the motion intention of the person, it is difficult to acquire the myoelectric potential due to the symptom of paralysis in the acute phase. The effect of Brain machine interface utilizing the electroencephalogram has been reported, but the adaptation to the lower limbs is little. Then, in this study, the brain machine interface adaptable to the leg is developed, and it aims at realizing the motion assistance along the intention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EEG data
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Rehabilitation
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
Key inclusion criteria	Healthy person
Key exclusion criteria	1. It is difficult for normal walking. 2. Injuries that affect the movements of lower limb. 3.Pain or injury in each joint or muscle of lower limbs 4.There is a trauma in the mounting part of the device
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Ishiyama
Organization	Waseda University
Division name	Faculty of Science and Engineering
Zip code	169-8555
Address	3-4-1 Okubo Shinjuku-ku, Tokyo
TEL	03-5286-3376
Email	atsushi@waseda.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Ishiyama
Organization	Waseda University
Division name	Faculty of Science and Engineering
Zip code	169-8555
Address	3-4-1 Okubo Shinjuku-ku, Tokyo
TEL	03-5286-3376
Homepage URL	http://www.eb.waseda.ac.jp/ishiyama/
Email	atsushi@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics review committee on Research with human subjects, Waseda University
Address	1-104 Totsuka-cho, Shinjuku-ku, Tokyo
Tel	03-5272-1639
Email	rinri@list.waseda.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	2019 Year 08 Month 05 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	Preinitiation
Date of protocol fixation	2019 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 05 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 02 Day
Last modified on	2019 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042843