UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016814 |
|---|---|
| Receipt number | R000019486 |
| Scientific Title | Efficacy of repetitive transcranial magnetic stimulation of the primary motor cortex for chemotherapy-induced neuropathic pain in patients with breast and gynecological cancer |
| Date of disclosure of the study information | 2015/03/16 |
| Last modified on | 2017/03/31 20:07:53 |
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Basic information
Public title
Efficacy of repetitive transcranial magnetic stimulation of the primary motor cortex for chemotherapy-induced neuropathic pain in patients with breast and gynecological cancer
Acronym
rTMS for chemotherapy-induced neuropathic pain
Scientific Title
Efficacy of repetitive transcranial magnetic stimulation of the primary motor cortex for chemotherapy-induced neuropathic pain in patients with breast and gynecological cancer
Scientific Title:Acronym
rTMS for chemotherapy-induced neuropathic pain
Region
| Japan |
Condition
Condition
Neuropathic pain induced by chemotherapy for breast and gynecological cancer
Classification by specialty
| Neurology | Breast surgery | Obstetrics and Gynecology |
| Anesthesiology | Neurosurgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of repetitive transcranial magnetic stimulation of the primary motor cortex for chemotherapy-induced neuropathic pain in patients with breast and gynecological cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain reduction in visual analogue scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Active stimulation (M1 hand)
Interventions/Control_2
Active stimulation (M1 hand, high stimulus intensity)
Interventions/Control_3
Active stimulation (M1 foot)
Interventions/Control_4
Sham stimulation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with peripheral neuropathic pain induced by chemotheraphy for breast or gynecological cancer
Patients with pain duration of 3 months or longer
Patients with moderate or sevvere pain (VAS: 30mm or more)
Patients with agreement with no change of ordinary drugs during trial
Patients with an informed consent given
Key exclusion criteria
Patients suffering from cognitive impairments, aphasia, or a major psychiatric disease
Patients with a desire for suicide
Patients who cannot write the questionnaires
Patients with an implanted metal in a head excluding a mouth
Patients with a cardiac pacemaker, devices for deep brain stimulation, or an implanted medication pump
Patients suffering from serious heart diseases
Patients suffering from a major cerebral infarction or head a trauma
Patients suffering from a brain tumor
Patients with epilepsy episode history
Pregnant patients
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Youichi Saitoh |
Organization
Osaka University
Division name
Department of Neuromodulation and Neurosurgery
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
+81-6-6210-8435
neurosaitoh@mbk.nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Hosomi |
Organization
Osaka University
Division name
Department of Neuromodulation and Neurosurgery
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
+81-6-6210-8435
Homepage URL
k-hosomi@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Department of Neuromodulation and Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Japanese Ministry of Health, Labour
and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka University Graduate School of Medicine, Department of Breast and Endcrine surgery, Department of Obstetrics and Gynecology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 03 | Month | 16 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 16 | Day |
Last modified on
| 2017 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019486
