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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025758
Receipt No. R000029635
Scientific Title Effects of brain activity dependent visual feedback training on phantom limb pain.
Date of disclosure of the study information 2017/01/31
Last modified on 2019/04/05

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Basic information
Public title Effects of brain activity dependent visual feedback training on phantom limb pain.
Acronym Effects of brain activity dependent visual feedback training on phantom limb pain.
Scientific Title Effects of brain activity dependent visual feedback training on phantom limb pain.
Scientific Title:Acronym Effects of brain activity dependent visual feedback training on phantom limb pain.
Region
Japan

Condition
Condition Amputee
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess effects of brain activity dependent visual feedback training on phantom limb pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes Intensity of phantom limb pain
Key secondary outcomes Electroencephalogram
Current perception thresholds
Somatosensory evoked potentials

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 Visual feedback depend on brain activity (1-15 days)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria The time from amputation longer than 180 days

The ability to translate without physical assistance in daily life
Key exclusion criteria The patients with pacemaker
The patients with serious heart disease
The patients with serious cognitive dysfunction
The patients with serious mental illness
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhiro Mizuno
Organization Keio University School of Medicine, Tokyo
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 03-5363-3833
Email mizuno.katsuhiro@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Okuyama Kohei
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 03-5363-3833
Homepage URL
Email okuyama@keio.jp

Sponsor
Institute Department of Rehabilitation Medicien, Keio University School of Medicine
Institute
Department

Funding Source
Organization Department of Rehabilitation Medicien, Keio University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 01 Month 31 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 Completed
Date of protocol fixation
2016 Year 10 Month 13 Day
Date of IRB
2016 Year 11 Month 28 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2019 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
2017 Year 01 Month 20 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029635

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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