Functional Neuroimaging in Fibromyalgia Patients Receiving tDCS
17 juillet 2013 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
34
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brésil, 90035-903
- Recrutement
- Hospital de Clinicas de Porto Alegre
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Contact:
- Wolnei Caumo, MD, PhD
- Numéro de téléphone: (51) 3359 8083
- E-mail: caumo@cpovo.net
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Chercheur principal:
- Wolnei Caumo, MD PhD
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur factice: 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).
Autres noms:
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.
Autres noms:
|
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Expérimental: 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).
Autres noms:
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in the pressure pain threshold.
Délai: 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.
|
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.
Délai: 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.
Délai: 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.
|
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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in the temperature pain threshold.
Délai: 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.
|
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.
|
|
Change in the visual analogue scale for pain to prolonged thermal stimuli.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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.
Délai: 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.
|
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.
Délai: 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.
Délai: 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.
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.
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Wolnei Caumo, MD, PhD, Hospital de Clinicas de Porto Alegre
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2013
Achèvement primaire (Anticipé)
1 juillet 2014
Achèvement de l'étude (Anticipé)
1 décembre 2014
Dates d'inscription aux études
Première soumission
8 juillet 2013
Première soumission répondant aux critères de contrôle qualité
17 juillet 2013
Première publication (Estimation)
22 juillet 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
22 juillet 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juillet 2013
Dernière vérification
1 juillet 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- La douleur
- Manifestations neurologiques
- Maladies musculo-squelettiques
- Maladies rhumatismales
- Maladies musculaires
- Maladies neuromusculaires
- La douleur chronique
- Fibromyalgie
- Syndromes de douleur myofasciale
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Analgésiques
- Agents du système sensoriel
- Agents tranquillisants
- Médicaments psychotropes
- Modulateurs de transport membranaire
- Agents anti-anxiété
- Anticonvulsivants
- Hormones et agents régulateurs du calcium
- Bloqueurs de canaux calciques
- Prégabaline
Autres numéros d'identification d'étude
- 120128
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .