UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016409 |
|---|---|
| Receipt number | 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 | 2024/08/12 16:20:06 |
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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
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
mkob@saitama-med.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Saitama Medical University Hospital
Institute
Department
Personal name
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
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
https://pubmed.ncbi.nlm.nih.gov/25906811/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/25906811/
Number of participants that the trial has enrolled
18
Results
The effects of the rTMS reached a plateau at the eighth week. At the 12th week, the rTMS was effective in 61.1% of the patients; 5 of the 18 patients showed more than 70% reduction based on a visual analog scale, 6 patients showed 40 to 69% reduction, and 7 remained at a pain reduction level of less than 40%.
Results date posted
| 2024 | Year | 08 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
18 patients (12men and 6women,aged 39 to 81 years; mean 63.0years), with a history of deep intracranial hemorrhagic or ischemic stroke. All of the
patients exhibited various degrees of hemiparesis and intractable pain in their paretic extremities caused by single unilateral stroke.
Participant flow
All of the 18 patients completed all of the 12-week sessions of repetitive transcranial magnetic stimulation, without dropping out
Adverse events
No patient experienced any severe adverse effects during or after the rTMS, but two patients reported transient, slight scalp discomfort after rTMS.
Outcome measures
The maximum reduction of the VAS (visual analogue scale) value ranged from 5 to 70 (mean 36.7 +- 21.1) from the 8th to 12th week.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019057
