Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long Term Home Based tDCS in Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03843203
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Wolnei Caumo, Hospital de Clinicas de Porto Alegre

Brief Summary:

Fibromyalgia(FM) is a widespread musculoskeletal pain syndrome characterized by fatigue, sleep disorders, cognitive impairment, depressive symptoms and neuro-vegetative symptoms. It is a multivariable and complex neurobiological process. FM worldwide prevalence according to American College of Rheumatology (ACR) 2010 diagnostic criteria is estimated under 5,4%. In USA the burden caused by FM is estimated at 29 billions every year, due to assistance, health care costs and retirement to loss of productivity. It is known that conventional pharmacological approaches present poor therapeutic response in more than 50% of these patients. It is conceivable that this limited results, at least in part, due to the lack of a complete elucidation of its pathophysiology.

Our hypothesis is that tDCS has a superior effect on clinical outcomes, functional capacity, cortical excitability, and psycho-affective functions compared to simulated treatment. In order to respond to the objectives of this study, a randomized, parallel-blinded clinical trial will be conducted. FM patients will be randomized to receive tDCS with anodic pole on the primary motor cortex and the cathode pole on the contralateral prefrontal cortex.


Condition or disease Intervention/treatment Phase
Fibromyalgia Transcranial Direct Current Stimulation Device: Transcranial Direct Current Stimulation - tDCS Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-Blind, Randomized, Parallel Group, Sham-Controlled Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The researcher will receive equipment already programmed by a research assistant, so the researcher who will deliver the tDCS to perform stimulation will not know the programed stimulation. Patients will be instructed to discuss aspects of treatment with the respective investigator. Two independent evaluators who will not participate in the consultations where guidance on the use of tDCS will be provided will be trained to make outcome assessments in follow-up. Patients will not be aware of the type of intervention received, since the sham condition produces a stimulus, but no expected effects. In order to study the level of the blinding, at each moment of evaluation, the patient will be asked about the type of intervention that he / she believes to have received (active or simulated), and about the degree of safety in the response, using a standardized questionnaire. The blinding will be evaluated at the end of each treatment week by means of a standardized instrument.
Primary Purpose: Treatment
Official Title: Efficacy and Effectivity of Long Term Home Based tDCS in Fibromyalgia: an Explanatory Randomized Clinical Trial
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Sham Comparator: s-tDCS
- Intervention: 'Transcranial Direct Current Stimulation - tDCS The patients will receive tDCS sham treatment. The patients will receive sham tDCS treatment over primary motor cortex. According to 10-20 EEG system, anode will be placed at left C3 and cathode at o contralateral F3. In sham stimulation the device only release flow current, in the first 30 s of session and in the remaining 30s in the end of the session, during 20 minutes.
Device: Transcranial Direct Current Stimulation - tDCS
- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it

Active Comparator: M1 a-tDCS
  • Intervention: 'Transcranial Direct Current Stimulation - tDCS
  • The patients will receive tDCS active treatment over primary motor cortex.
  • According to 10-20 EEG system, anode will be placed at left C3 and cathode at contralateral supraorbital Fp2.
  • Active stimulation uses a 2 milliamperes current during 20 minutes.
Device: Transcranial Direct Current Stimulation - tDCS
- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it

Active Comparator: DLPFC a-tDCS
  • Intervention: 'Transcranial Direct Current Stimulation - tDCS
  • The patients will receive tDCS active treatment over dorsolateral prefrontal cortex.
  • According to 10-20 EEG system, anode will be placed at left F3 and cathode at contralateral F4.
  • Active stimulation uses a 2 milliamperes current during 20 minutes.
Device: Transcranial Direct Current Stimulation - tDCS
- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it




Primary Outcome Measures :
  1. Change in pain level - first phase [ Time Frame: 1 month ]
    Change from before and after the First phase of treatment on Pain scores assessed by a visual analogue scale (VAS 0 to 100mm) (0 means no pain - 100 means the worst pain imaginable)

  2. Change in functional capacity - first phase [ Time Frame: 1 month ]
    Change from before and after the First phase of treatment on Total score on the Brazilian Profile of Chronic Pain: Screen (BPCP:S) (range from 0 to 93; high numbers means more pain severity, interference in daily activities and emotional burden)


Secondary Outcome Measures :
  1. Change in pain level - second phase [ Time Frame: 3 months ]
    Change from before and after the Second phase of treatment on Pain scores assessed by a visual analogue scale (VAS 0 to 100mm) (0 means no pain - 100 means the worst pain imaginable)

  2. Change in functional capacity - second phase [ Time Frame: 3 months ]
    Change from before and after the First phase of treatment on Total score on the Brazilian Profile of Chronic Pain: Screen (BPCP:S) (range from 0 to 93; high numbers means more pain severity, interference in daily activities and emotional burden)

  3. Change in Function of modulatory descending system [ Time Frame: 1 month ]
    Change from before and after the First phase of treatment on the score in a numerical pain scale (NPS 0-10) for a moderate heat pain stimulus to the right arm (ventral region) during a conditioned pain modulation task (CPM-task), where participant keeps the counter-lateral hand in an iced cold water (0 to 1º Celsius)

  4. Change in Function of corticospinal pathway [ Time Frame: 1 month ]
    Change from before and after the First phase of treatment on measures of motor threshold (MT), motor evoked potential (MEP), intracortical facilitation (ICF), short intracortical inhibition (SICI), and cortical silent period (CSP) assessed with transcranial magnetic stimulation (TMS).

  5. Change in levels of Brain derived neurotrophic factor - BDNF [ Time Frame: 1 month ]
    Blood samples will be collected at baseline and after the First phase of intervention in order to determine BDNF serum levels using a standardized kit

  6. Polymorphism of Brain derived neurotrophic factor - BDNF [ Time Frame: 10 minutes ]
    Blood samples will be collected at baseline in order to determine BDNF gene polymorphism for the G allele (rs6265)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women, who are able to read and write, with confirmed diagnosis of FM 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.

Exclusion Criteria:

  • Reside outside the Greater Porto Alegre area
  • Pregnancy
  • Contraindications to TMS and tDCS: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemaker; cochlear implant;
  • History of alcohol or drug abuse in the last 6 months; neurological diseases; history of head trauma or neurosurgery; decompensated systemic diseases, and chronic inflammatory diseases (lupus, rheumatoid arthritis, Sjogren's syndrome, Reiter's syndrome); uncompensated hypothyroidism; personal history of cancer, past or under treatment.

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): NCT03843203


Contacts
Layout table for location contacts
Contact: Wolnei Caumo, PhD +5551 3359 8083 wcaumo@hcpa.edu.br

Locations
Layout table for location information
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         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Layout table for investigator information
Study Director: Wolnei Caumo, PhD Federal University of Rio Grande do Sul

Publications:
Layout table for additonal information
Responsible Party: Wolnei Caumo, Professor, M.D, PhD., Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03843203     History of Changes
Other Study ID Numbers: 2017-0330
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Pain
Brain derived neurotrophic factor
functional capacity
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases