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Effect of tDCS in Intrinsic Functional Brain Connectivity Assessed by Functional Magnetic Resonance in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03841227
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Wolnei Caumo, Hospital de Clinicas de Porto Alegre

Brief Summary:

Considering the central component of fibromyalgia (FM), the focus of research on current therapeutic approaches has been techniques that may modify the dysfunctional neuroplasticity process, such as transcranial direct current (tDCS) stimulation in order to counteract the dysfunction responsible for triggering and maintain the symptoms of FM. Although this technique is gaining space in research and in the clinical scenario, many questions remain to be answered, such as time of treatment, place to be stimulated and neurophysiological clarification of the mechanisms involved.

Based on the presented scenario, the present project was organized, being a double-blinded parallel randomized controlled trial with 20 female patients with FM diagnosed according to the criteria of the American Society of Rheumatology (2010 - reviewed in 2016) between 19 and 65 years of age, randomized to receive active or simulated anodic pole over the left dorsolateral prefrontal cortex (DLPFC) (10 patients in each group). Twenty 20-minute sessions, with a current intensity of 2 milliamperes, will be performed.

In order to respond to the objectives of this study, the IFC will be evaluated before and after the intervention, through rs-fMRI using seed-based correlation analysis (SCA). The investigators have a secondary objective to correlate structural connectivity through the technique of diffusion tensors imaging (DTI) with measures of pain, functional capacity, depressive symptoms and catastrophism to pain.

The hypothesis is that in FM there is a syndrome of dysfunction in basal intrinsic functional connectivity (IFC) and that the tDCS has a neuromodulatory effect capable of reducing connectivity between brain areas related to chronic pain and other neuropsychiatric components of FM, such as the ventrolateral thalamus, cortex motor, prefrontal cortex, insular cortex, hippocampus, periaqueductal gray matter, among others. The investigators believe that a higher cortico-thalamic IFC and between regions with high density of opioid receptors have a positive predictive response in the treatment of tDCS.


Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Active-tDCS Device: Sham-tDCS Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Transcranial Continuous Current Neuromodulation in Intrinsic Functional Brain Connectivity Assessed by Functional Magnetic Resonance Imaging (fMRI) in Fibromyalgia: A Randomized, Double-blind Controlled Trial
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Active Comparator: Active-tDCS
10 patients will receive Active-tDCS intervention (2mA, 20 min) at home.
Device: Active-tDCS
Active home-based tDCS applied at home. 5 days a week for 4 weeks.

Sham Comparator: Sham-tDCS
10 patients will receive Sham-tDCS intervention (2mA, 20 min) at home.
Device: Sham-tDCS
Sham home-based tDCS applied at home. 5 days a week for 4 weeks.




Primary Outcome Measures :
  1. Change from Baseline Functional cerebral connectivity(rs-fMRI)to post-intervention rs-fMRI [ Time Frame: 30 minutes ]
    Evaluation of functional cerebral connectivity using resting-state functional magnetic resonance imaging (rs-fMRI) between the change in baseline and post-intervention assessments.


Secondary Outcome Measures :
  1. Structural cerebral connectivity [ Time Frame: 30 minutes ]
    Evaluation of structural cerebral connectivity using diffusion tract imaging (DTI)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Literate
  • Female, between 18 and 65 years old
  • With the diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology (2010-2016)
  • Pain score equal to or greater than six on the Numerical Pain Scale (NPS 0-10) on most days of the last 3 months.
  • Give informed consent to participate after the initial evaluation.

Exclusion Criteria:

  • Living outside the city of Porto Alegre, RS, Brazil
  • Pregnancy
  • Severe Mental Illness
  • tDCS contraindications
  • Magnetic resonance imaging (MRI) contraindications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841227


Contacts
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Contact: Wolnei Caumo, PhD +5551 3359 8083 wcaumo@cpovo.net

Locations
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Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90.450-120
Contact: Wolnei Caumo, PhD    +5551 3359 8083    wcaumo@hcpa.edu.br   
Principal Investigator: Wolnei Caumo, PhD         
Sub-Investigator: Matheus D Soldatelli, MD         
Hospital de Clinicas e Porto Alegre (HCPA) Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
Contact: Wolnei Caumo    55 51 99813977    caumo@cpovo.net   
Principal Investigator: Wolnei Caumo         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Wolnei Caumo, PhD Federal University of Rio Grande do Sul

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Responsible Party: Wolnei Caumo, Professor at the Post-Graduation Program in Medical Sciences, Faculty of Medicine, UFRGS, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03841227     History of Changes
Other Study ID Numbers: 2018-0353
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wolnei Caumo, Hospital de Clinicas de Porto Alegre:
fibromyalgia
tDCS
fMRI
rs-fMRI

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases