UMIN-CTR Clinical Trial

Basic information
Public title	Study of repetitive periphery sensory nerve electric stimulation for sensory disturbance in central nervous system disorder.
Acronym	Effect of repetitive peripheral sensory nerve stimulation for sensory disturbance in stroke patients.
Scientific Title	Study of repetitive periphery sensory nerve electric stimulation for sensory disturbance in central nervous system disorder.
Scientific Title:Acronym	Effect of repetitive peripheral sensory nerve stimulation for sensory disturbance in stroke patients.
Region	Japan

Condition
Condition	stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the feasibility of repetitive peripheral sensory nerve stimulation for sensory disturbance in stroke patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Semmes Weinstein Monofilaments test, Moberg's pick up test
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	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Training for sensory disorder combined with sensory nereve electrical stimulation
Interventions/Control_2	Training for sensory disorder
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Sensory disorders caused by single stroke (onset >6 months), normal consciousness with stable medical and neulogical status.
Key exclusion criteria	The patient that a disorder was not able to understand study contents.the patient having dermatosis at an electrode patch position.The patient whom pacemaker is buried in.In addition, we exclude the patient who judged that a doctor has difficulty with this study participation.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kentaro Kobayashi
Organization	Jikei University School of Medicine
Division name	Department of Rehabilitation Medicine
Zip code
Address	3-19-18 Nishishinbashi Tokyo, Minato-ku, Japan
TEL	03-3433-1111
Email	kobakent0319@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Kentaro Kobayashi
Organization	Jikei University School of Medicine
Division name	Department of Rehabilitation Medicine
Zip code
Address	3-19-18 Nishishinbashi Tokyo, Minato-ku, Japan
TEL	03-3433-1111
Homepage URL
Email	kobakent0319@yahoo.co.jp

Sponsor
Institute	Jikei University School of Medicine
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
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	東京慈恵会医科大学付属病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 19 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	2012 Year 12 Month 11 Day
Date of IRB	2019 Year 03 Month 31 Day
Anticipated trial start date	2012 Year 12 Month 11 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	2014 Year 08 Month 18 Day
Last modified on	2019 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016226