UMIN-CTR Clinical Trial

Basic information
Public title	bionic blood-pressure stabilization system for intractable postural hypotension in patients with spinal cord injury
Acronym	bionic blood-pressure stabilization system for intractable postural hypotension in patients with spinal cord injury
Scientific Title	bionic blood-pressure stabilization system for intractable postural hypotension in patients with spinal cord injury
Scientific Title:Acronym	bionic blood-pressure stabilization system for intractable postural hypotension in patients with spinal cord injury
Region	Japan

Condition
Condition	spinal cord injury
Classification by specialty	Cardiology Neurology Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	assessment of postural hypotension in patients with spinal cord injury, and assessment of stabilization of blood pressure by transcutaneous electrical stimulation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	suppression of postural hypotension
Key secondary outcomes	improvement of symptoms safety

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	transcutaneous electrical stimulation by bionic blood pressure stabilization system
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with spinal cord injury postural hypotension
Key exclusion criteria	consciousness disturbance patients incapable of agreement
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kenji Sunagawa
Organization	Kyushu University
Division name	Department of cardiovascular medicine
Zip code
Address	3-1-1 Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL	092-642-5359
Email	jsmbe@cardiol.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Koji Todaka
Organization	Kyushu University Hospital
Division name	Center for Clinical and Translational Research
Zip code
Address	3-1-1 Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL	092-642-5092
Homepage URL
Email	jsmbe@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	Kyushu University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Spinal Injuries Center
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	総合せき損センター

Other administrative information
Date of disclosure of the study information	2013 Year 12 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	Terminated
Date of protocol fixation	2013 Year 08 Month 13 Day
Date of IRB	2013 Year 08 Month 13 Day
Anticipated trial start date	2013 Year 09 Month 13 Day
Last follow-up date	2018 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	2013 Year 12 Month 17 Day
Last modified on	2020 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014746