UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006267
Receipt number R000007405
Scientific Title Development of an artificial neural connection device for neurorehabilitation
Date of disclosure of the study information 2011/09/01
Last modified on 2020/09/22 21:03:28

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Basic information

Public title

Development of an artificial neural connection device for neurorehabilitation

Acronym

Development of an artificial neural connection device for neurorehabilitation

Scientific Title

Development of an artificial neural connection device for neurorehabilitation

Scientific Title:Acronym

Development of an artificial neural connection device for neurorehabilitation

Region

Japan


Condition

Condition

healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Development of therapy for motor functional recovery by building artificial neural connections with magnetic stimulation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

motor function, electromyography

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Activity dependent simultaneous spinal and cutaneous stimulation

Interventions/Control_2

Activity dependent spinal stimulation

Interventions/Control_3

Activity dependent cutaneous stimulation

Interventions/Control_4

Activity independent spinal stimulation

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

healty adults, who give written informed consent after detailed explanation of the study

Key exclusion criteria

history of psychiatric disease, severe head trauma, history of brain surgery, epilepsy, cardiac arrhythmia, implanted cardiac pace maker, deep brain stimulation device, insulin pump or wires, pregnancy

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Yoshikazu
Middle name
Last name Ugawa

Organization

Fukushima Medical University

Division name

Department of Neurology

Zip code

960-1295

Address

1 Hikarigaoka, Fukushima, Japan

TEL

+81-24-547-1248

Email

ugawa-tky@umin.net


Public contact

Name of contact person

1st name Suguru
Middle name
Last name Kadowaki

Organization

Fukushima Medical University

Division name

Department of Neurology

Zip code

960-1295

Address

1 Hikarigaoka, Fukushima, Japan

TEL

+81-24-547-1248

Homepage URL


Email

skado@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University, School of Medicine, Department of Neurology

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Division of Behavioral Development, Department of Developmental Physiology, National Institute for Physiological Sciences

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board, Fukushima Medical University

Address

1 Hikarigaoka, Fukushima, Japan

Tel

+81-24-547-1825

Email

rs@fmu.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

2011 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

10

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

Completed

Date of protocol fixation

2011 Year 08 Month 01 Day

Date of IRB

2011 Year 08 Month 30 Day

Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date

2018 Year 12 Month 10 Day

Date of closure to data entry

2018 Year 12 Month 10 Day

Date trial data considered complete

2018 Year 12 Month 10 Day

Date analysis concluded

2018 Year 12 Month 10 Day


Other

Other related information



Management information

Registered date

2011 Year 09 Month 01 Day

Last modified on

2020 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007405


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name