Functional Neuroimaging in Fibromyalgia Patients Receiving tDCS
NCT ID: NCT01904097
Last Updated: 2013-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
34 participants
INTERVENTIONAL
2013-03-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pregabalin, Sham tDCS
Patients will receive pregabalin 150 mg oral (PO) twice per day (BID), and sham transcranial direct current stimulation (sham tDCS) five times per week during 2 weeks, and then twice per week until week 8th. The sham tDCS consists of the same montage of the active tDCS, but the device is turned off 30 seconds after initiating stimulation (without letting the patient notice it). Rest of the montage is kept identical as the active one during the 30 minutes that the session lasts.
Pregabalin
Pregabalin 150 mg per oral BID (i.e. twice per day).
Sham Transcranial Direct Current Stimulation
The sham tDCS consists of the same montage of the active tDCS, but the device is turned off 30 seconds after initiating stimulation (without letting the patient notice it). Rest of the montage is kept identical as the active one during the 30 minutes that the session lasts.
Pregabalin, tDCS
Patients will receive pregabalin 150 mg oral(PO) twice per day (BID), and transcranial direct current stimulation (tDCS) five times per week during 2 weeks, and then twice per week until week 8th. The tDCS consists of application of low intensity direct current (2 mA), with the anode placed in the dominant motor cortex (M1) and the cathode in the ipsilateral supraorbital region during 30 minutes each session, using sponge electrodes soaked with normal saline solution.
Pregabalin
Pregabalin 150 mg per oral BID (i.e. twice per day).
Transcranial Direct Current Stimulation
The tDCS consists of application of low intensity direct current (2 mA), with the anode placed in the dominant motor cortex (M1) and the cathode in the ipsilateral supraorbital region during 30 minutes each session, using sponge electrodes soaked with normal saline solution.
Interventions
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Pregabalin
Pregabalin 150 mg per oral BID (i.e. twice per day).
Transcranial Direct Current Stimulation
The tDCS consists of application of low intensity direct current (2 mA), with the anode placed in the dominant motor cortex (M1) and the cathode in the ipsilateral supraorbital region during 30 minutes each session, using sponge electrodes soaked with normal saline solution.
Sham Transcranial Direct Current Stimulation
The sham tDCS consists of the same montage of the active tDCS, but the device is turned off 30 seconds after initiating stimulation (without letting the patient notice it). Rest of the montage is kept identical as the active one during the 30 minutes that the session lasts.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* De-compensated systemic disease.
* Chronic inflammatory disease (e.g. Systemic Lupus Erythematous, Rheumatoid Arthritis).
18 Years
65 Years
FEMALE
No
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Principal Investigators
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Wolnei Caumo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Locations
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Russell IJ, Raphael KG. Fibromyalgia syndrome: presentation, diagnosis, differential diagnosis, and vulnerability. CNS Spectr. 2008 Mar;13(3 Suppl 5):6-11. doi: 10.1017/s1092852900026778.
Burgmer M, Pogatzki-Zahn E, Gaubitz M, Wessoleck E, Heuft G, Pfleiderer B. Altered brain activity during pain processing in fibromyalgia. Neuroimage. 2009 Jan 15;44(2):502-8. doi: 10.1016/j.neuroimage.2008.09.008. Epub 2008 Sep 24.
Ziemann U, Lonnecker S, Steinhoff BJ, Paulus W. Effects of antiepileptic drugs on motor cortex excitability in humans: a transcranial magnetic stimulation study. Ann Neurol. 1996 Sep;40(3):367-78. doi: 10.1002/ana.410400306.
Arnold LM. Biology and therapy of fibromyalgia. New therapies in fibromyalgia. Arthritis Res Ther. 2006;8(4):212. doi: 10.1186/ar1971.
Chizh BA, Gohring M, Troster A, Quartey GK, Schmelz M, Koppert W. Effects of oral pregabalin and aprepitant on pain and central sensitization in the electrical hyperalgesia model in human volunteers. Br J Anaesth. 2007 Feb;98(2):246-54. doi: 10.1093/bja/ael344.
Dooley DJ, Mieske CA, Borosky SA. Inhibition of K(+)-evoked glutamate release from rat neocortical and hippocampal slices by gabapentin. Neurosci Lett. 2000 Feb 18;280(2):107-10. doi: 10.1016/s0304-3940(00)00769-2.
Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum. 2006 Dec;54(12):3988-98. doi: 10.1002/art.22195.
Nitsche MA, Fricke K, Henschke U, Schlitterlau A, Liebetanz D, Lang N, Henning S, Tergau F, Paulus W. Pharmacological modulation of cortical excitability shifts induced by transcranial direct current stimulation in humans. J Physiol. 2003 Nov 15;553(Pt 1):293-301. doi: 10.1113/jphysiol.2003.049916. Epub 2003 Aug 29.
Taber KH, Hillman EM, Hurley RA. Optical imaging: a new window to the adult brain. J Neuropsychiatry Clin Neurosci. 2010 Fall;22(4):iv, 357-60. doi: 10.1176/jnp.2010.22.4.iv. No abstract available.
Other Identifiers
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120128
Identifier Type: -
Identifier Source: org_study_id
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