UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023721 |
|---|---|
| Receipt number | 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 22:14:28 |
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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
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
on5083@msn.com
Sponsor or person
Institute
Taipei Veterans General Hospital, Taiwan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027325
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| Registered date | File name |
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| Research case data | |
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