UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Repetitive Transcranial Magnetic Stimulationfor 2010 criteria diagnosed Fibromyalgia with a comorbidity of depression: Evidence from a pilot Randomized Sham-Controlled Study
Title of the study (Brief title)	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	Cheng-Ta Li
Organization	Taipei Veterans General Hospital, Taiwan
Division name	Psychiatry
Address	No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan
TEL	+88628757027
Email	on5083@msn.com

Public contact
Name of contact person	Cheng-Ta Li
Organization	Taipei Veterans General Hospital, Taiwan
Division name	Psychiatry
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 09 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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