Functional Neuroimaging in Fibromyalgia Patients Receiving tDCS

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Unknown status
CT.gov ID
NCT01904097
Collaborator
(none)
34
1
2
21
1.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pregabalin
  • Other: Transcranial Direct Current Stimulation
  • Other: Sham Transcranial Direct Current Stimulation
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Study of the Brain With Optic Functional Neuroimaging in Patients With Chronic Pain Using Transcranial Direct Current Stimulation
Study Start Date :
Mar 1, 2013
Anticipated Primary Completion Date :
Jul 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: 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.

Drug: Pregabalin
Pregabalin 150 mg per oral BID (i.e. twice per day).
Other Names:
  • Lyrica
  • Other: 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 Names:
  • Sham tDCS
  • Experimental: 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.

    Drug: Pregabalin
    Pregabalin 150 mg per oral BID (i.e. twice per day).
    Other Names:
  • Lyrica
  • Other: 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.
    Other Names:
  • tDCS
  • Outcome Measures

    Primary Outcome Measures

    1. Change in the pressure pain threshold. [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.

    2. Change in cortical excitability parameters assessed by transcranial magnetic stimulation. [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.

    3. Changes in motor cortex blood flow assessed by near infrared spectroscopy. [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.

    Secondary Outcome Measures

    1. Change in the temperature pain threshold. [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.

    2. Change in the visual analogue scale for pain to prolonged thermal stimuli. [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.

    3. Change in average daily pain assessed with the visual analogue scale. [Starting on day 1, each day until Week 12. Total: 84 Evaluations.]

      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.

    4. Change in the Fibromyalgia Impact Questionnaire. [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.

    5. Change in quality of life assessed by the WHOQOL (World Health Organization Quality of Life), reduced form, adapted to Brazilian Portuguese. [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.

    Other Outcome Measures

    1. Serum biomarkers levels: The brain derived neurotrophic factor, salivary cortisol, tumor necrosis factor alpha, Interleukin 1, 6 and 10 levels will be measured. [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.

    2. Level of depressive symptoms. [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.

    3. Sleep quality. [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.

    4. Pain catastrophizing thoughts. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande do Sul Brazil 90035-903

    Sponsors and Collaborators

    • Hospital de Clinicas de Porto Alegre

    Investigators

    • Principal Investigator: Wolnei Caumo, MD, PhD, Hospital de Clínicas de Porto Alegre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hospital de Clinicas de Porto Alegre
    ClinicalTrials.gov Identifier:
    NCT01904097
    Other Study ID Numbers:
    • 120128
    First Posted:
    Jul 22, 2013
    Last Update Posted:
    Jul 22, 2013
    Last Verified:
    Jul 1, 2013

    Study Results

    No Results Posted as of Jul 22, 2013