Functional Neuroimaging in Fibromyalgia Patients Receiving tDCS
keskiviikko 17. heinäkuuta 2013 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Tuntematon
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Odotettu)
34
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilia, 90035-903
- Rekrytointi
- Hospital de Clínicas de Porto Alegre
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Ottaa yhteyttä:
- Wolnei Caumo, MD, PhD
- Puhelinnumero: (51) 3359 8083
- Sähköposti: caumo@cpovo.net
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Päätutkija:
- Wolnei Caumo, MD PhD
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 65 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Nainen
Kuvaus
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).
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Huijausvertailija: 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 150 mg per oral BID (i.e.
twice per day).
Muut nimet:
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.
Muut nimet:
|
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Kokeellinen: 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).
Muut nimet:
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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in the pressure pain threshold.
Aikaikkuna: 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.
|
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.
Aikaikkuna: 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.
|
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.
Aikaikkuna: 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.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in the temperature pain threshold.
Aikaikkuna: 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.
|
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Change in the visual analogue scale for pain to prolonged thermal stimuli.
Aikaikkuna: 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.
|
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.
Aikaikkuna: 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.
Aikaikkuna: 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.
Fibromyalgia Impact Questionnaire will be assessed 2, 8 and 12 weeks after initiating the allocated intervention.
Total: Four Evaluations.
|
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.
Aikaikkuna: 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.
|
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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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Serum biomarkers levels: The brain derived neurotrophic factor, salivary cortisol, tumor necrosis factor alpha, Interleukin 1, 6 and 10 levels will be measured.
Aikaikkuna: 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.
|
|
Level of depressive symptoms.
Aikaikkuna: 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.
|
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.
Aikaikkuna: 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.
|
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.
Aikaikkuna: Day 1 (1 hour before receiving the 1st dose of pregabalin), week 2 and week 8 after initiating the allocated intervention.
|
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.
|
Day 1 (1 hour before receiving the 1st dose of pregabalin), week 2 and week 8 after initiating the allocated intervention.
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Wolnei Caumo, MD, PhD, Hospital de Clínicas de Porto Alegre
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Perjantai 1. maaliskuuta 2013
Ensisijainen valmistuminen (Odotettu)
Tiistai 1. heinäkuuta 2014
Opintojen valmistuminen (Odotettu)
Maanantai 1. joulukuuta 2014
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 8. heinäkuuta 2013
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 17. heinäkuuta 2013
Ensimmäinen Lähetetty (Arvio)
Maanantai 22. heinäkuuta 2013
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Maanantai 22. heinäkuuta 2013
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 17. heinäkuuta 2013
Viimeksi vahvistettu
Maanantai 1. heinäkuuta 2013
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Hermoston sairaudet
- Kipu
- Neurologiset ilmenemismuodot
- Tuki- ja liikuntaelinten sairaudet
- Reumaattiset sairaudet
- Lihassairaudet
- Neuromuskulaariset sairaudet
- Krooninen kipu
- Fibromyalgia
- Myofaskiaalinen kipuoireyhtymä
- Huumeiden fysiologiset vaikutukset
- Farmakologisen vaikutuksen molekyylimekanismit
- Keskushermostoa lamaavat aineet
- Ääreishermoston aineet
- Analgeetit
- Aistijärjestelmän agentit
- Rauhoittavat aineet
- Psykotrooppiset lääkkeet
- Kalvon kuljetusmodulaattorit
- Ahdistuneisuutta ehkäisevät aineet
- Antikonvulsantit
- Kalsiumia säätelevät hormonit ja aineet
- Kalsiumkanavan salpaajat
- Pregabaliini
Muut tutkimustunnusnumerot
- 120128
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .