UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of repetitive transcranial magnetic stimulation on chronic post-stroke pain
Title of the study (Brief title)	rTMS on chronic post-stroke pain
Region	Japan

Condition
Condition	patients with chronic post-stroke pain
Classification by specialty	Neurology Neurosurgery Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of rTMS on chronic post-stroke pain
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual Analogue Scale, Short-Form McGill Pain Questionnaire, Beck Depression Inventory, measured before, just after and 4 weeks after rTMS
Key secondary outcomes	MEP SSEP SPECT

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	10Hz rTMS on affected motor cortex (hand area),2000 pulses/day x 5 days at 80% of motor threshold intensity using Magstim Rapid stimulator.
Interventions/Control_2	10Hz rTMS on affected motor cortex (face area),2000 pulses/day x 5 days at 80% of motor threshold intensity using Magstim Rapid stimulator.
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	Patients with post-stroke pain
Key exclusion criteria	Patients with contraindication of rTMS
Target sample size	20

Research contact person
Name of lead principal investigator	Ken Johkura
Organization	Yokohama Brain and Spine Center
Division name	Department of Neurology
Address	1-2-1 Takigashira, Isogo-ku, Yokohama 235-0012, Japan
TEL	045-753-2500
Email	ke00-johkura@city.yokohama.jp

Public contact
Name of contact person	Ken Johkura
Organization	Yokohama Brain and Spine Center
Division name	Department of Neurology
Address	1-2-1 Takigashira, Isogo-ku, Yokohama 235-0012, Japan
TEL	045-753-2500
Homepage URL
Email	ke00-johkura@city.yokohama.jp

Sponsor
Institute	Yokohama Brain and Spine Center
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)

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 10 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 10 Month 01 Day
Last modified on	2018 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039156