xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05963321</url>
    </required_header>
    <id_info>
      <org_study_id>2022-0504</org_study_id>
      <nct_id>NCT05963321</nct_id>
    </id_info>
    <brief_title>Cortical Excitability Modulation With ctDCS in Fibromyalgia.</brief_title>
    <acronym>ctDCS</acronym>
    <official_title>Cortical Excitability Modulation With Cerebellar Transcranial Direct Current Stimulation in Fibromyalgia: a Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital de Clinicas de Porto Alegre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital de Clinicas de Porto Alegre</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this research, the objective is to evaluate the effect of cerebellar tDCS on clinical&#xD;
        measures of pain and cortical excitability in participants with fibromyalgia. This is a&#xD;
        randomized, double-blind, controlled clinical trial that has as its primary outcome the&#xD;
        evaluation of the variations in motor evoked potential (MEP) (a neuropsychological outcome)&#xD;
        and the visual analog scale (VAS) as a clinical outcome.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this research, the objective is to evaluate the effect of cerebellar tDCS on clinical&#xD;
        measures of pain and cortical excitability in participants with fibromyalgia. This is a&#xD;
        randomized, double-blind, controlled clinical trial that has as its primary outcome the&#xD;
        evaluation of the variations in motor evoked potential (MEP) (a neuropsychological outcome)&#xD;
        and the visual analog scale (VAS) as a clinical outcome. Secondary outcomes include the&#xD;
        silent period (CSP), intra-cortical facilitation (ICF), and intra-cortical inhibition (ICI)&#xD;
        obtained through TMS, the function of the descending modulator path of pain by the&#xD;
        conditioned modulation test (CPM test), the Brief Pain Inventory (BPI), and the pain&#xD;
        thresholds by heat, pressure, and cold. The intervention consists of an tDCS session in which&#xD;
        the active electrode will be located in the cerebellum and/or in the primary motor cortex (4&#xD;
        stimulation protocols that will be implemented: active cerebellum electrode- active M1&#xD;
        electrode, sham cerebellum electrode - active M1 electrode, active cerebellum-M1 sham&#xD;
        electrode, sham cerebellum electrode-M1 sham electrode) and the cathode in the contralateral&#xD;
        supra orbital region. The equipment will apply a current of 2 mA for 20 minutes. In total,&#xD;
        there will be 92 patients, divided into 4 intervention blocks composed of 23 individuals&#xD;
        each.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in motor evoked potential (MEP).</measure>
      <time_frame>Up to 60 min after tDCS onset.</time_frame>
      <description>Change from before and after tDCS onset on MEP. Assessed by a variation in the amplitude obtained by 20 stimuli with an intensity of 120% of the MT. The MEP will be considered the arithmetic mean of the amplitude of the wave recorded by the EMG.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in pain level</measure>
      <time_frame>Up to 60 min after tDCS onset.</time_frame>
      <description>Change from before and after tDCS onset on Pain scores assessed by a visual analogue scale (VAS 0 to 100mm) (0 means no pain - 100 means the worst pain imaginable)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in the Brief Pain Inventory (BPI) score</measure>
      <time_frame>Up to 15 days after tDCS onset.</time_frame>
      <description>It is a quick, simple, and easy-to-apply questionnaire that allows a multidimensional pain assessment to be carried out. The BPI consists of 15 items that determine the severity, existence, location, functional interference, applied therapeutic strategies, and efficacy of pain treatment. In the research, this questionnaire will be implemented at baseline, 8 and 15 days after tDCS onset.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in other measures obtained through transcranial magnetic stimulation</measure>
      <time_frame>Up to 60 min after tDCS onset.</time_frame>
      <description>Other measures of cortical excitability obtained through TMS include the silent period (CSP), intra-cortical facilitation (ICF) and intra-cortical inhibition (SICI). The TMS measures will be performed at two different times: before and after tDCS onset.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change in conditioned pain modulation (CPM)</measure>
      <time_frame>Up to 60 min after tDCS onset.</time_frame>
      <description>Conditioned pain modulation (CPM) is an experimental psychophysical measure that assesses supraspinal descending inhibitory mechanisms of pain modulation. In practice, a constant noxious stimulus (conditioning stimulus) is applied to one part of the body and a phasic stimulus (stimulus to be tested) to a distant part of the body before, during, and after the conditioning stimulus. The CPM is analyzed through the reduction that occurs in the perception of pain in the test stimulus.The conditioned pain modulation will be performed at two different times: before and after the single tDCS onset.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the quantitative sensory test (QST)</measure>
      <time_frame>Up to 60 min after tDCS onset.</time_frame>
      <description>The quantitative sensory test (QST) evaluates the function of myelinated, small and unmyelinated fibers, also including the function of the spinothalamic tract and nociceptive fibers. In addition, the QST represents a non-invasive method, which determines the gain or loss of sensory perception in response to external stimuli of controlled intensity in a previously determined body area.&#xD;
  The following tests will be carried out in the research:&#xD;
  Painful pressure threshold: performed with a pressure algometer, applied on the upper extremity.&#xD;
  Cold pressor test: the patient puts his extremity in a container with ice. The tolerance time will be determined.&#xD;
  Sensation of heat: using a heat electrode applied to the extremity corresponding to the sensitive alteration, the first sensation of heat and the painful threshold of light, medium and maximum heat will be evaluated.&#xD;
  The QST measures will be performed at two different times; before and after the tDCS onset.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>levels of Brain derived neurotrophic factor</measure>
      <time_frame>Blood samples will be collected at baseline, before tDCS onset.</time_frame>
      <description>Blood samples will be collected at baseline in order to determine BDNF serum levels using a standardized kit</description>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">92</enrollment>
    <condition>Fibromyalgia</condition>
    <condition>Chronic Pain</condition>
    <arm_group>
      <arm_group_label>Active cerebellum electrode and active M1 electrode</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Two tDCS devices will be used simultaneously. In cerebellar stimulation (active), the anodal electrode will be positioned on the right side, with the center of the sponge approximately 3 cm from the ion; on the other hand, in cortical stimulation (active), the anodal electrode will be located in the left primary motor cortex. In both cerebellar and cortical stimulations, the cathode will be positioned in the contralateral supraorbital region. The equipment will apply a current of 2 mA for 20 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham cerebellar electrode and active M1 electrode</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Two tDCS devices will be used simultaneously. In cerebellar stimulation (sham), the anodal electrode will be positioned on the right side, with the center of the sponge approximately 3 cm from the ion; on the other hand, in cortical stimulation (active), the anodal electrode will be located in the left primary motor cortex. In both cerebellar and cortical stimulations, the cathode will be positioned in the contralateral supraorbital region. The equipment will apply a current of 2 mA for 20 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active cerebellum electrode and sham M1 electrode</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Two tDCS devices will be used simultaneously. In cerebellar stimulation (active), the anodal electrode will be positioned on the right side, with the center of the sponge approximately 3 cm from the ion; on the other hand, in cortical stimulation (sham), the anodal electrode will be located in the left primary motor cortex. In both cerebellar and cortical stimulations, the cathode will be positioned in the contralateral supraorbital region. The equipment will apply a current of 2 mA for 20 minutes</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham cerebellar electrode and sham M1 electrode</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Two tDCS devices will be used simultaneously. In cerebellar stimulation (sham), the anodal electrode will be positioned on the right side, with the center of the sponge approximately 3 cm from the ion; on the other hand, in cortical stimulation (sham), the anodal electrode will be located in the left primary motor cortex. In both cerebellar and cortical stimulations, the cathode will be positioned in the contralateral supraorbital region. The equipment will apply a current of 2 mA for 20 minutes</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>TDCS</intervention_name>
      <description>Two tDCS devices will be used simultaneously. The intervention consists of a tDCS session in which the active electrode will be located in the cerebellum and/or in the primary motor cortex (4 stimulation protocols that will be implemented; active cerebellum electrode and active M1 electrode, sham cerebellum electrode and active M1 electrode, active cerebellum and sham M1 electrode, sham cerebellar electrode and sham M1 electrode) and the cathode in the contralateral supraorbital region. The equipment will apply a current of 2 mA for 20 minutes.</description>
      <arm_group_label>Active cerebellum electrode and active M1 electrode</arm_group_label>
      <arm_group_label>Active cerebellum electrode and sham M1 electrode</arm_group_label>
      <arm_group_label>Sham cerebellar electrode and active M1 electrode</arm_group_label>
      <arm_group_label>Sham cerebellar electrode and sham M1 electrode</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Right-handed women aged 18 to 65 years; who can read and write&#xD;
  &#xD;
            -  Confirmed diagnosis of fibromyalgia according to the criteria of the American College&#xD;
               of Rheumatology (2010-2016).&#xD;
  &#xD;
            -  Pain score equal to or greater than 6 on the Numerical Pain Scale (Score 0-10) on most&#xD;
               days in the last 3 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Reside outside Porto Alegre area.&#xD;
  &#xD;
            -  Confirmed pregnancy&#xD;
  &#xD;
            -  Contraindications to TMS and tDCS: metallic implant in the brain; medical devices&#xD;
               implanted in the brain, heart pacemaker; cochlear implant; history of alcohol or drug&#xD;
               abuse in the last 6 months; neurological pathologies; hx of head trauma or&#xD;
               neurosurgery; decompensated systemic diseases and chronic inflammatory diseases&#xD;
               (lupus, rheumatoid arthritis, Reiter's syndrome); uncompensated hypothyroidism;&#xD;
               personal history of cancer, past or undergoing treatment.&#xD;
  &#xD;
            -  Participants with diagnosis or recent contact with COVID will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wolnei Caumo, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Hospital de Clinicas de Porto Alegre</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wolnei Caumo, PhD</last_name>
      <phone>55 51 33596377</phone>
      <phone_ext>6377</phone_ext>
      <email>wcaumo@hcpa.edu.br</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital de Clinicas de Porto Alegre</name>
        <address>
          <city>Porto Alegre</city>
          <state>Rio Grande Do Sul</state>
          <zip>90.450-120</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wolnei Caumo, PhD</last_name>
        <phone>+5551 3359 8083</phone>
        <email>wcaumo@hcpa.edu.br</email>
      </contact>
      <investigator>
        <last_name>Wolnei Caumo, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hospital de clinicas de Porto Alegre</name>
        <address>
          <city>Porto Alegre</city>
          <state>Rio Grande Do Sul</state>
          <zip>9410000</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniel Fernando Arias Betancur</last_name>
        <phone>51997511560</phone>
        <email>dbetancur@hcpa.edu.br</email>
      </contact>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <reference>
      <citation>Ferrucci R, Cortese F, Priori A. Cerebellar tDCS: how to do it. Cerebellum. 2015 Feb;14(1):27-30. doi: 10.1007/s12311-014-0599-7.</citation>
      <PMID>25231432</PMID>
    </reference>
    <reference>
      <citation>van Dun K, Bodranghien FC, Marien P, Manto MU. tDCS of the Cerebellum: Where Do We Stand in 2016? Technical Issues and Critical Review of the Literature. Front Hum Neurosci. 2016 May 11;10:199. doi: 10.3389/fnhum.2016.00199. eCollection 2016.</citation>
      <PMID>27242469</PMID>
    </reference>
    <reference>
      <citation>Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.</citation>
      <PMID>20633386</PMID>
    </reference>
    <reference>
      <citation>Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.</citation>
      <PMID>27866120</PMID>
    </reference>
    <reference>
      <citation>Lefaucheur JP. Transcranial magnetic stimulation. Handb Clin Neurol. 2019;160:559-580. doi: 10.1016/B978-0-444-64032-1.00037-0.</citation>
      <PMID>31277876</PMID>
    </reference>
    <reference>
      <citation>Ugawa Y, Day BL, Rothwell JC, Thompson PD, Merton PA, Marsden CD. Modulation of motor cortical excitability by electrical stimulation over the cerebellum in man. J Physiol. 1991 Sep;441:57-72. doi: 10.1113/jphysiol.1991.sp018738.</citation>
      <PMID>1816387</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Fibromyalgia</keyword>
    <keyword>Cerebellum</keyword>
    <keyword>Transcranial direct current magnetic stimulation</keyword>
    <keyword>Transcranial magnetic stimulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fibromyalgia</mesh_term>
      <mesh_term>Myofascial Pain Syndromes</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05963321
  org study id: 2022-0504
  nct id: NCT05963321
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this research, the objective is to evaluate the effect of cerebellar tDCS on clinical
        measures of pain and cortical excitability in participants with fibromyalgia. This is a
        randomized, double-blind, controlled clinical trial that has as its primary outcome the
        evaluation of the variations in motor evoked potential (MEP) (a neuropsychological outcome)
        and the visual analog scale (VAS) as a clinical outcome.
  In this research, the objective is to evaluate the effect of cerebellar tDCS on clinical
        measures of pain and cortical excitability in participants with fibromyalgia. This is a
        randomized, double-blind, controlled clinical trial that has as its primary outcome the
        evaluation of the variations in motor evoked potential (MEP) (a neuropsychological outcome)
        and the visual analog scale (VAS) as a clinical outcome. Secondary outcomes include the
        silent period (CSP), intra-cortical facilitation (ICF), and intra-cortical inhibition (ICI)
        obtained through TMS, the function of the descending modulator path of pain by the
        conditioned modulation test (CPM test), the Brief Pain Inventory (BPI), and the pain
        thresholds by heat, pressure, and cold. The intervention consists of an tDCS session in which
        the active electrode will be located in the cerebellum and/or in the primary motor cortex (4
        stimulation protocols that will be implemented: active cerebellum electrode- active M1
        electrode, sham cerebellum electrode - active M1 electrode, active cerebellum-M1 sham
        electrode, sham cerebellum electrode-M1 sham electrode) and the cathode in the contralateral
        supra orbital region. The equipment will apply a current of 2 mA for 20 minutes. In total,
        there will be 92 patients, divided into 4 intervention blocks composed of 23 individuals
        each.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in motor evoked potential (MEP).
  time frame: Up to 60 min after tDCS onset.
  description: Change from before and after tDCS onset on MEP. Assessed by a variation in the amplitude obtained by 20 stimuli with an intensity of 120% of the MT. The MEP will be considered the arithmetic mean of the amplitude of the wave recorded by the EMG.
  measure: Change in pain level
  time frame: Up to 60 min after tDCS onset.
  description: Change from before and after tDCS onset on Pain scores assessed by a visual analogue scale (VAS 0 to 100mm) (0 means no pain - 100 means the worst pain imaginable)
  measure: Change in the Brief Pain Inventory (BPI) score
  time frame: Up to 15 days after tDCS onset.
  description: It is a quick, simple, and easy-to-apply questionnaire that allows a multidimensional pain assessment to be carried out. The BPI consists of 15 items that determine the severity, existence, location, functional interference, applied therapeutic strategies, and efficacy of pain treatment. In the research, this questionnaire will be implemented at baseline, 8 and 15 days after tDCS onset.
  measure: Change in other measures obtained through transcranial magnetic stimulation
  time frame: Up to 60 min after tDCS onset.
  description: Other measures of cortical excitability obtained through TMS include the silent period (CSP), intra-cortical facilitation (ICF) and intra-cortical inhibition (SICI). The TMS measures will be performed at two different times: before and after tDCS onset.
  measure: change in conditioned pain modulation (CPM)
  time frame: Up to 60 min after tDCS onset.
  description: Conditioned pain modulation (CPM) is an experimental psychophysical measure that assesses supraspinal descending inhibitory mechanisms of pain modulation. In practice, a constant noxious stimulus (conditioning stimulus) is applied to one part of the body and a phasic stimulus (stimulus to be tested) to a distant part of the body before, during, and after the conditioning stimulus. The CPM is analyzed through the reduction that occurs in the perception of pain in the test stimulus.The conditioned pain modulation will be performed at two different times: before and after the single tDCS onset.
  measure: Change in the quantitative sensory test (QST)
  time frame: Up to 60 min after tDCS onset.
  description: The quantitative sensory test (QST) evaluates the function of myelinated, small and unmyelinated fibers, also including the function of the spinothalamic tract and nociceptive fibers. In addition, the QST represents a non-invasive method, which determines the gain or loss of sensory perception in response to external stimuli of controlled intensity in a previously determined body area.
  The following tests will be carried out in the research:
  Painful pressure threshold: performed with a pressure algometer, applied on the upper extremity.
  Cold pressor test: the patient puts his extremity in a container with ice. The tolerance time will be determined.
  Sensation of heat: using a heat electrode applied to the extremity corresponding to the sensitive alteration, the first sensation of heat and the painful threshold of light, medium and maximum heat will be evaluated.
  The QST measures will be performed at two different times; before and after the tDCS onset.
  measure: levels of Brain derived neurotrophic factor
  time frame: Blood samples will be collected at baseline, before tDCS onset.
  description: Blood samples will be collected at baseline in order to determine BDNF serum levels using a standardized kit
  arm group label: Active cerebellum electrode and active M1 electrode
  arm group type: Active Comparator
  description: Two tDCS devices will be used simultaneously. In cerebellar stimulation (active), the anodal electrode will be positioned on the right side, with the center of the sponge approximately 3 cm from the ion; on the other hand, in cortical stimulation (active), the anodal electrode will be located in the left primary motor cortex. In both cerebellar and cortical stimulations, the cathode will be positioned in the contralateral supraorbital region. The equipment will apply a current of 2 mA for 20 minutes.
  arm group label: Sham cerebellar electrode and active M1 electrode
  arm group type: Active Comparator
  description: Two tDCS devices will be used simultaneously. In cerebellar stimulation (sham), the anodal electrode will be positioned on the right side, with the center of the sponge approximately 3 cm from the ion; on the other hand, in cortical stimulation (active), the anodal electrode will be located in the left primary motor cortex. In both cerebellar and cortical stimulations, the cathode will be positioned in the contralateral supraorbital region. The equipment will apply a current of 2 mA for 20 minutes.
  arm group label: Active cerebellum electrode and sham M1 electrode
  arm group type: Active Comparator
  description: Two tDCS devices will be used simultaneously. In cerebellar stimulation (active), the anodal electrode will be positioned on the right side, with the center of the sponge approximately 3 cm from the ion; on the other hand, in cortical stimulation (sham), the anodal electrode will be located in the left primary motor cortex. In both cerebellar and cortical stimulations, the cathode will be positioned in the contralateral supraorbital region. The equipment will apply a current of 2 mA for 20 minutes
  arm group label: Sham cerebellar electrode and sham M1 electrode
  arm group type: Sham Comparator
  description: Two tDCS devices will be used simultaneously. In cerebellar stimulation (sham), the anodal electrode will be positioned on the right side, with the center of the sponge approximately 3 cm from the ion; on the other hand, in cortical stimulation (sham), the anodal electrode will be located in the left primary motor cortex. In both cerebellar and cortical stimulations, the cathode will be positioned in the contralateral supraorbital region. The equipment will apply a current of 2 mA for 20 minutes
  intervention type: Device
  intervention name: TDCS
  description: Two tDCS devices will be used simultaneously. The intervention consists of a tDCS session in which the active electrode will be located in the cerebellum and/or in the primary motor cortex (4 stimulation protocols that will be implemented; active cerebellum electrode and active M1 electrode, sham cerebellum electrode and active M1 electrode, active cerebellum and sham M1 electrode, sham cerebellar electrode and sham M1 electrode) and the cathode in the contralateral supraorbital region. The equipment will apply a current of 2 mA for 20 minutes.
  arm group label: Active cerebellum electrode and active M1 electrode
  arm group label: Active cerebellum electrode and sham M1 electrode
  arm group label: Sham cerebellar electrode and active M1 electrode
  arm group label: Sham cerebellar electrode and sham M1 electrode
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Wolnei Caumo, PhD
  role: Study Director
  affiliation: Hospital de Clinicas de Porto Alegre
  last name: Wolnei Caumo, PhD
  phone: 55 51 33596377
  phone ext: 6377
  email: wcaumo@hcpa.edu.br
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  country: Brazil
  citation: Ferrucci R, Cortese F, Priori A. Cerebellar tDCS: how to do it. Cerebellum. 2015 Feb;14(1):27-30. doi: 10.1007/s12311-014-0599-7.
  PMID: 25231432
  citation: van Dun K, Bodranghien FC, Marien P, Manto MU. tDCS of the Cerebellum: Where Do We Stand in 2016? Technical Issues and Critical Review of the Literature. Front Hum Neurosci. 2016 May 11;10:199. doi: 10.3389/fnhum.2016.00199. eCollection 2016.
  PMID: 27242469
  citation: Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
  PMID: 20633386
  citation: Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
  PMID: 27866120
  citation: Lefaucheur JP. Transcranial magnetic stimulation. Handb Clin Neurol. 2019;160:559-580. doi: 10.1016/B978-0-444-64032-1.00037-0.
  PMID: 31277876
  citation: Ugawa Y, Day BL, Rothwell JC, Thompson PD, Merton PA, Marsden CD. Modulation of motor cortical excitability by electrical stimulation over the cerebellum in man. J Physiol. 1991 Sep;441:57-72. doi: 10.1113/jphysiol.1991.sp018738.
  PMID: 1816387
  responsible party type: Sponsor
  mesh term: Fibromyalgia
  mesh term: Myofascial Pain Syndromes
  mesh term: Chronic Pain
  sharing ipd: No