UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036306
Receipt number R000041367
Scientific Title Development of novel communication tools using brain signals
Date of disclosure of the study information 2019/04/01
Last modified on 2024/03/30 11:35:46

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Basic information

Public title

Development of novel communication tools using brain signals

Acronym

Novel communication tools using brain signals

Scientific Title

Development of novel communication tools using brain signals

Scientific Title:Acronym

Novel communication tools using brain signals

Region

Japan


Condition

Condition

Normal adult and child, Amyotrophic lateral sclerosis (ALS)

Classification by specialty

Neurology Adult Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To establish novel communication tools using brain signals.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Accuracy of brain machine interface

Key secondary outcomes

Brain activity(EEG, fMRI), movements(EMG, reaction time, etc.), Psychological evaluation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

existence of attention to sensory stimulus

Interventions/Control_2

kind of sense

Interventions/Control_3

stimulus location and strength

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

6 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Normal adults, physically handicapped adults, and normal children (above 6 years old) who actively participate with written informed consent of the participants or their proxies.

Key exclusion criteria

persons with heavily secondary disability

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Toshimitsu
Middle name
Last name Takahashi

Organization

Dokkyo Medical University School of Medicine

Division name

Department of Physiology

Zip code

321-0293

Address

880 Kitakobayashi, Mibu, Shimotsuga, Tochigi

TEL

0282-87-2126

Email

tositaka@dokkyomed.ac.jp


Public contact

Name of contact person

1st name Toshimitsu
Middle name
Last name Takahashi

Organization

Dokkyo Medical University School of Medicine

Division name

Department of Physiology

Zip code

321-0293

Address

880 Kitakobayashi, Mibu, Shimotsuga, Tochigi

TEL

0282-87-2126

Homepage URL


Email

tositaka@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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

Ethical Review Board of Dokkyo Medical University School of Medicine

Address

880 Kitakobayashi, Mibu, Shimotsuga, Tochigi

Tel

0282-87- 2474

Email

kenkyu@dokkyomed.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

2019 Year 04 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

Preinitiation

Date of protocol fixation

2019 Year 04 Month 01 Day

Date of IRB

2019 Year 02 Month 26 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2026 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 03 Month 27 Day

Last modified on

2024 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041367


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name