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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016409
Receipt No. R000019057
Scientific Title Clinical study on stroke recovery and the long-term effects of repetitive transcranial stimulation on central post-stroke pain
Date of disclosure of the study information 2015/02/02
Last modified on 2019/08/09

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Basic information
Public title Clinical study on stroke recovery and the long-term effects of repetitive transcranial stimulation on central post-stroke pain
Acronym Stroke recovery and long-term relief of central post-stroke pain induced by rTMS
Scientific Title Clinical study on stroke recovery and the long-term effects of repetitive transcranial stimulation on central post-stroke pain
Scientific Title:Acronym Stroke recovery and long-term relief of central post-stroke pain induced by rTMS
Region
Japan

Condition
Condition Neuropathic pain such as central post-stroke pain
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test the possibility that rTMS once a week would induce sustainable relief of medication-resistant post-stroke pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes The degree of the pain will be assessed at each rTMS session.
Key secondary outcomes Adverse effect if any.

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
Maneuver
Interventions/Control_1 rTMS with stimulating intensity of 90% of the active motor threshold, 10 trains of 10-second 5Hz-rTMS will be delivered over the motor cortex on the affected side. This rTMS session will be repeated once a week.
Period: 3 months (12 weeks). For the subjects who give us informed consents, the intervention will be continued for one year (52 weeks).
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
25 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria patients exhibited various degrees of intractable pain in their paretic extremities caused by neurological lesions such as stroke
Key exclusion criteria History of epilepsy
Presence of intracranial metal
Electrodes inside the heart
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masahito
Middle name
Last name Kobayashi
Organization Saitama Medical University Hospital
Division name Neurosurgery
Zip code 3500495
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama 350-0495
TEL 049-276-1287
Email mkob@saitama-med.ac.jp

Public contact
Name of contact person
1st name Masahito
Middle name
Last name Kobayashi
Organization Saitama Medical University Hospital
Division name Neurosurgery
Zip code 3500495
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama 350-0495
TEL 049-276-1287
Homepage URL
Email mkob@saitama-med.ac.jp

Sponsor
Institute Department of Neurosurgery, Saitama Medical University Hospital
Institute
Department

Funding Source
Organization Saitama Medical University Hospital
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Saitama Medical University Hospital IRB
Address Saitama Medical University Hospital
Tel 049-276-1111
Email hirb@saitama-med.ac.jp

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 埼玉医科大学病院、美原記念病院

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 02 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2006 Year 02 Month 20 Day
Date of IRB
2016 Year 11 Month 07 Day
Anticipated trial start date
2006 Year 02 Month 28 Day
Last follow-up date
2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 01 Day
Last modified on
2019 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019057

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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