Functional Neuroimaging in Fibromyalgia Patients Receiving tDCS
17 juli 2013 bijgewerkt door: Hospital de Clinicas de Porto Alegre
Study of the Brain With Optic Functional Neuroimaging in Patients With Chronic Pain Using Transcranial Direct Current Stimulation
The purpose of this study is to evaluate effectiveness and cerebral neuronal ability to adaptation in patients with fibromyalgia who receive pregabalin and transcranial direct current stimulation.
Studie Overzicht
Toestand
Onbekend
Conditie
Gedetailleerde beschrijving
Fibromyalgia syndrome occurs in around 2% of the population (predominantly women), and is characterized by its poor response to conventional therapies.
Therapeutic approaches modulating inhibitory pathways, including pharmacologic options as pregabalin, and non pharmacological ones as transcranial direct current stimulation (tDCS) have been proven to be of limited utility independently.
Aiming to evaluate a better understanding of the pathophysiogenic mechanisms and the effect of these treatments on neuroplasticity, this study was designed evaluating neurophysiologic, neurochemical and clinical parameters.
Neurophysiologic parameters and functions to be assessed will include pain threshold, motor evoked potential, silent period, intracortical facilitation and inhibition assessed by Transcranial Magnetic Stimulation (TMS) and optic functional neuroimaging.
Neurochemical measurements considered will be neurotrophins (BDNF) and inflammatory mediators (TNF, IL1, IL6, IL10 and cortisol).
Clinical characteristics will be assessed using validated scales capable to detect functional capacity, quality of life (WHOCOHL), catastrophism, sleep disruptions (Pittsburgh) and depressive symptoms (Beck Depression Inventory).
Considering the above described hypothesis, the present randomized clinical trial with blinded patients and evaluators is proposed.
It pretends to analyze short-, mid- and long-term neurobiological mechanisms triggered by the selected interventions.
Studietype
Ingrijpend
Inschrijving (Verwacht)
34
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazilië, 90035-903
- Werving
- Hospital de Clinicas de Porto Alegre
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Contact:
- Wolnei Caumo, MD, PhD
- Telefoonnummer: (51) 3359 8083
- E-mail: caumo@cpovo.net
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Hoofdonderzoeker:
- Wolnei Caumo, MD PhD
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- - Diagnosis of fibromyalgia according to the American College of Rheumatology criteria
Exclusion Criteria:
- Psychiatric or neurologic disorder that unable patient to consent and follow study protocol.
- De-compensated systemic disease.
- Chronic inflammatory disease (e.g. Systemic Lupus Erythematous, Rheumatoid Arthritis).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Sham-vergelijker: 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.
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Pregabalin 150 mg per oral BID (i.e.
twice per day).
Andere namen:
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.
Andere namen:
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Experimenteel: 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 150 mg per oral BID (i.e.
twice per day).
Andere namen:
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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in the pressure pain threshold.
Tijdsspanne: Day 1 (1 hour before receiving the 1st dose of pregabalin; and 1 hour after the first dose of pregabalin); week 2 and week 8 after initiating the allocated intervention.
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Assessed with pressure algometer.
Will be assessed before and 1 hour after a single dose of 150 mg of Pregabalin.
Patients will also receive pregabalin 150 mg BID + tDCS (or sham tDCS) daily during 2 weeks, and then twice per week until week 8th.
Pain thresholds will be assessed 2 and 8 weeks after initiating the allocated intervention.
Total: Four evaluations.
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Day 1 (1 hour before receiving the 1st dose of pregabalin; and 1 hour after the first dose of pregabalin); week 2 and week 8 after initiating the allocated intervention.
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Change in cortical excitability parameters assessed by transcranial magnetic stimulation.
Tijdsspanne: Day 1 (1 hour before receiving the 1st dose of pregabalin; and 1 hour after the first dose of pregabalin); week 2 and week 8 after initiating the allocated intervention.
|
Will be assessed before and 1 hour after a single dose of 150 mg of Pregabalin.
Patients will also receive pregabalin 150 mg BID + tDCS (or sham tDCS) daily during 2 weeks, and then twice per week until week 8th.
Cortical Excitability will be assessed 2 and 8 weeks after initiating the allocated intervention.
Total: Four Evaluations.
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Day 1 (1 hour before receiving the 1st dose of pregabalin; and 1 hour after the first dose of pregabalin); week 2 and week 8 after initiating the allocated intervention.
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Changes in motor cortex blood flow assessed by near infrared spectroscopy.
Tijdsspanne: Day 1 (1 hour before receiving the 1st dose of pregabalin; and 1 hour after the first dose of pregabalin); week 2 and week 8 after initiating the allocated intervention.
|
Will be assessed before and 1 hour after a single dose of 150 mg of Pregabalin.
Patients will also receive pregabalin 150 mg BID + tDCS (or sham tDCS) daily during 2 weeks, and then twice per week until week 8th.
Motor cortex blood flow will be assessed 2 and 8 weeks after initiating the allocated intervention.
Total: Four Evaluations.
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Day 1 (1 hour before receiving the 1st dose of pregabalin; and 1 hour after the first dose of pregabalin); week 2 and week 8 after initiating the allocated intervention.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in the temperature pain threshold.
Tijdsspanne: Day 1 (1 hour before receiving the 1st dose of pregabalin; and 1 hour after the first dose of pregabalin); week 2 and week 8 after initiating the allocated intervention.
|
Will be assessed before and 1 hour after a single dose of 150 mg of Pregabalin.
Patients will also receive pregabalin 150 mg BID + tDCS (or sham tDCS) daily during 2 weeks, and then twice per week until week 8th.
Pain thresholds will be assessed 2 and 8 weeks after initiating the allocated intervention.
Total: Four Evaluations.
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Day 1 (1 hour before receiving the 1st dose of pregabalin; and 1 hour after the first dose of pregabalin); week 2 and week 8 after initiating the allocated intervention.
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Change in the visual analogue scale for pain to prolonged thermal stimuli.
Tijdsspanne: Day 1 (1 hour before receiving the 1st dose of pregabalin; and 1 hour after the first dose of pregabalin); week 2 and week 8 after initiating the allocated intervention.
|
Will be assessed before and 1 hour after a single dose of 150 mg of Pregabalin.
Patients will also receive pregabalin 150 mg BID + tDCS (or sham tDCS) daily during 2 weeks, and then twice per week until week 8th.
Pain to prolonged thermal stimuli will be assessed 2 and 8 weeks after initiating the allocated intervention.
Total: Four Evaluations.
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Day 1 (1 hour before receiving the 1st dose of pregabalin; and 1 hour after the first dose of pregabalin); week 2 and week 8 after initiating the allocated intervention.
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Change in average daily pain assessed with the visual analogue scale.
Tijdsspanne: Starting on day 1, each day until Week 12. Total: 84 Evaluations.
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Patients will be asked to daily write down their average pain level (assessed by the Visual Analogue Scale, self-administered) in a paper diary.
Total evaluations: 84.
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Starting on day 1, each day until Week 12. Total: 84 Evaluations.
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Change in the Fibromyalgia Impact Questionnaire.
Tijdsspanne: Day 1 (1 hour before receiving the 1st dose of pregabalin); week 2, week 8 and week 12 after initiating the allocated intervention.
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Will be assessed before initiating treatment.
Patients will receive pregabalin 150 mg BID + tDCS (or sham tDCS) daily during 2 weeks, and then twice per week until week 8th.
Fibromyalgia Impact Questionnaire will be assessed 2, 8 and 12 weeks after initiating the allocated intervention.
Total: Four Evaluations.
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Day 1 (1 hour before receiving the 1st dose of pregabalin); week 2, week 8 and week 12 after initiating the allocated intervention.
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Change in quality of life assessed by the WHOQOL (World Health Organization Quality of Life), reduced form, adapted to Brazilian Portuguese.
Tijdsspanne: Day 1 (1 hour before receiving the 1st dose of pregabalin), week 2, week 8 and week 12 after initiating the allocated intervention.
|
Will be assessed before initiating treatment.
Patients will receive pregabalin 150 mg BID + tDCS (or sham tDCS) daily during 2 weeks, and then twice per week until week 8th.
Quality of life will be assessed 2, 8 and 12 weeks after initiating the allocated intervention.
Total: Four Evaluations.
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Day 1 (1 hour before receiving the 1st dose of pregabalin), week 2, week 8 and week 12 after initiating the allocated intervention.
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Serum biomarkers levels: The brain derived neurotrophic factor, salivary cortisol, tumor necrosis factor alpha, Interleukin 1, 6 and 10 levels will be measured.
Tijdsspanne: Day 1 (1 hour before receiving the 1st dose of pregabalin; and 1 hour after the first dose of pregabalin); week 2 and week 8 after initiating the allocated intervention.
|
Will be assessed before and 1 hour after a single dose of 150 mg of Pregabalin.
Patients will also receive pregabalin 150 mg BID + tDCS (or sham tDCS) daily during 2 weeks, and then twice per week until week 8th.
Motor cortex blood flow will be assessed 2 and 8 weeks after initiating the allocated intervention.
Total: Four Evaluations.
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Day 1 (1 hour before receiving the 1st dose of pregabalin; and 1 hour after the first dose of pregabalin); week 2 and week 8 after initiating the allocated intervention.
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Level of depressive symptoms.
Tijdsspanne: Day 1 (1 hour before receiving the 1st dose of pregabalin), week 2 and week 8 after initiating the allocated intervention.
|
Will be assessed before initiating treatment.
Patients will receive pregabalin 150 mg BID + tDCS (or sham tDCS) daily during 2 weeks, and then twice per week until week 8th.
Depression symptoms will be assessed using the Beck Depression Inventory, which covers neurovegetative symptoms of depression.
It will be assessed 2 and 8 weeks after initiating the allocated intervention.
Total: Three Evaluations.
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Day 1 (1 hour before receiving the 1st dose of pregabalin), week 2 and week 8 after initiating the allocated intervention.
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Sleep quality.
Tijdsspanne: Day 1 (1 hour before receiving the 1st dose of pregabalin), week 2 and week 8 after initiating the allocated intervention.
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Will be assessed before initiating treatment.
Patients will receive pregabalin 150 mg BID + tDCS (or sham tDCS) daily during 2 weeks, and then twice per week until week 8th.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index and the 10 cm scale of sleep quality.
It will be assessed 2 and 8 weeks after initiating the allocated intervention.
Total: Three Evaluations.
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Day 1 (1 hour before receiving the 1st dose of pregabalin), week 2 and week 8 after initiating the allocated intervention.
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Pain catastrophizing thoughts.
Tijdsspanne: Day 1 (1 hour before receiving the 1st dose of pregabalin), week 2 and week 8 after initiating the allocated intervention.
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The level of catastrophic thinking will be assessed by the scale of catastrophic thoughts adapted to the Brazilian population (BP-PCS).
Will be assessed before initiating treatment.
Patients will receive pregabalin 150 mg PO BID + tDCS (or sham tDCS) daily during 2 weeks, and then twice per week until week 8th.
Pain catastrophizing thoughts will be assessed 2 and 8 weeks after initiating the allocated intervention.
Total: Three Evaluations.
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Day 1 (1 hour before receiving the 1st dose of pregabalin), week 2 and week 8 after initiating the allocated intervention.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Wolnei Caumo, MD, PhD, Hospital de Clinicas de Porto Alegre
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- Arnold LM. Biology and therapy of fibromyalgia. New therapies in fibromyalgia. Arthritis Res Ther. 2006;8(4):212. doi: 10.1186/ar1971.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2013
Primaire voltooiing (Verwacht)
1 juli 2014
Studie voltooiing (Verwacht)
1 december 2014
Studieregistratiedata
Eerst ingediend
8 juli 2013
Eerst ingediend dat voldeed aan de QC-criteria
17 juli 2013
Eerst geplaatst (Schatting)
22 juli 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
22 juli 2013
Laatste update ingediend die voldeed aan QC-criteria
17 juli 2013
Laatst geverifieerd
1 juli 2013
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het zenuwstelsel
- Pijn
- Neurologische manifestaties
- Musculoskeletale aandoeningen
- Reumatische aandoeningen
- Spierziekten
- Neuromusculaire aandoeningen
- Chronische pijn
- Fibromyalgie
- Myofasciale pijnsyndromen
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Depressiva van het centrale zenuwstelsel
- Agenten van het perifere zenuwstelsel
- Pijnstillers
- Sensorische systeemagenten
- Rustgevende agenten
- Psychotrope medicijnen
- Membraantransportmodulatoren
- Middelen tegen angst
- Anticonvulsiva
- Calciumregulerende hormonen en middelen
- Calciumantagonisten
- Pregabaline
Andere studie-ID-nummers
- 120128
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .