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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016814
Receipt No. 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

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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 Obsterics 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
Email 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
Email k-hosomi@nsurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine, Department of Neuromodulation and Neurosurgery
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019486

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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