UMIN-CTR Clinical Trial

Basic information
Public title	Effects of transcranial direct current electrical stimulation combined with aerobic exercise on pressure pain thresholds and neuropathic pain in spinal cord injury
Acronym	Transcranial direct current electrical stimulation and aerobic exercise on pressure pain thresholds and neuropathic pain
Scientific Title	Effects of transcranial direct current electrical stimulation combined with aerobic exercise on pressure pain thresholds and neuropathic pain in spinal cord injury
Scientific Title:Acronym	Transcranial direct current electrical stimulation and aerobic exercise on pressure pain thresholds and neuropathic pain
Region	Japan

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

Objectives
Narrative objectives1	To clarify the effectiveness of transcranial direct current stimulation combined with aerobic exercise on pressure pain threshold and neuropathic pain after spinal cord injury
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Pressure pain threshold 2)Pain intensity(neuropathic pain): numerical rating scale 3)Resting state electroencephalogram: peak alpha frequency 4)Mood (Profile of Mood State)
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Transcranial direct current stimulation combined with aerobic exercise
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Satisfy the following conditions 1)Age: 20-75 2)The patients with chronich spinal cord injury with neuropathic pain 3)Pain duration: 1year<
Key exclusion criteria	Severe orthopedic disease, Brain injury, Meental disease
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Gosuke Sato
Organization	Kio University
Division name	Neuro rehabilitation research center
Zip code
Address	4-2-2 Umaminaka, Koryo-cho, Nara
TEL	0745-54-1601
Email	gpamjl@live.jp

Public contact
Name of contact person	1st name Middle name Last name Gosuke Sato
Organization	Kio University
Division name	Neuro rehabilitation research center
Zip code
Address	4-2-2 Umaminaka, Koryo-cho, Nara
TEL	0745-54-1601
Homepage URL
Email	gpamjl@live.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
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
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	2018 Year 02 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	2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date	2018 Year 01 Month 30 Day
Last follow-up date	2020 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 20 Day
Last modified on	2020 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035266