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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023721
Receipt No. R000027325
Scientific Title Repetitive Transcranial Magnetic Stimulationfor 2010 criteria diagnosed Fibromyalgia with a comorbidity of depression: Evidence from a pilot Randomized Sham-Controlled Study
Date of disclosure of the study information 2016/08/22
Last modified on 2017/05/17

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Basic information
Public title Repetitive Transcranial Magnetic Stimulationfor 2010 criteria diagnosed Fibromyalgia with a comorbidity of depression: Evidence from a pilot Randomized Sham-Controlled Study
Acronym the analgesic effect of rTMS in patients with modified 2010 ACR and comorbided with major depressive disorder
Scientific Title Repetitive Transcranial Magnetic Stimulationfor 2010 criteria diagnosed Fibromyalgia with a comorbidity of depression: Evidence from a pilot Randomized Sham-Controlled Study
Scientific Title:Acronym the analgesic effect of rTMS in patients with modified 2010 ACR and comorbided with major depressive disorder
Region
Asia(except Japan)

Condition
Condition A treatment option for Medication-resistant fibromyalgia
Classification by specialty
Medicine in general Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate and compare the efficacy between left sided prefrontal 10 Hz rTMS and sham stimulation to treat fibromyalgia in patients with major depressive disorder.
Basic objectives2 Others
Basic objectives -Others We further evaluate the serum inflammatory factors or Brain activity by FDG-PET or cognitive function to find predicting factors of the analgesic effect of rTMS.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes the changing of VAS-pain (week-2 vs. baseline) in response to the 2-week prefrontalrTMS
Key secondary outcomes FDG-PET; CANTAB for working memory, go/no-goand MSCEIT; serum IL-2, IL-6, TNF-alpha, insulin, CRP; Young mania Rating scale; Clinical Global Index; Hamilton Depression Rating Scales-17 item; Life stress scale; Pittsburgh Sleep Quality Index;12-Item Short Form Health Survey; short-form McGill Pain Questionnaire; Patient Health Questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Left DLPFC 10Hz rTMS group (1 session/day, 5 days/week,2weeks); 100% motor threshold,1600 pulses once
Interventions/Control_2 Sham group(1 session/day, 5 days/week,2weeks)
using a sham coil.
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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria adult patients with a modified ACR 2010 diagnosis of fibromyalgia and major depressive disorder
Key exclusion criteria Patients were excluded if they had a lifetime psychiatric history of psychotic disorders, bipolar I or II disorder, substance abuse or dependence, personality disorders (based on DSM-IV criteria) or a lifetime medical history of major systemic illness, neurological disorders (e.g. stroke, post-brain surgery, epilepsy, traumatic brain injury), or cardiac pacemakers, brain implants or neurostimulators; or if they were pregnant.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Cheng-Ta Li
Organization Taipei Veterans General Hospital, Taiwan
Division name Psychiatry
Zip code
Address No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan
TEL +88628757027
Email on5083@msn.com

Public contact
Name of contact person
1st name
Middle name
Last name Cheng-Ta Li
Organization Taipei Veterans General Hospital, Taiwan
Division name Psychiatry
Zip code
Address No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan
TEL +88628757027
Homepage URL
Email on5083@msn.com

Sponsor
Institute Taipei Veterans General Hospital, Taiwan
Institute
Department

Funding Source
Organization Taipei Veterans General Hospital, Taiwan
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Taiwan, ROC

Other related organizations
Co-sponsor
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
2016 Year 08 Month 22 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 Open public recruiting
Date of protocol fixation
2013 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 11 Day
Last follow-up date
2016 Year 09 Month 10 Day
Date of closure to data entry
2016 Year 09 Month 10 Day
Date trial data considered complete
2016 Year 09 Month 10 Day
Date analysis concluded
2016 Year 09 Month 10 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 22 Day
Last modified on
2017 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027325

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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