<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/NCT03036137</url>
  </required_header>
  <id_info>
    <org_study_id>61192416.9.0000.5188</org_study_id>
    <nct_id>NCT03036137</nct_id>
  </id_info>
  <brief_title>Impact of Neurostimulation on Patterns of Brain Electrical Activity in Patients With Tinnitus</brief_title>
  <official_title>IMPACT OF TRANSCRANIAL DIRECT CURRENT STIMULATION ON THE STANDARDS OF CEREBRAL ELECTRIC ACTIVITY IN PATIENTS WITH CHRONIC TINNITUS: CLINICAL TRIAL, DOUBLE BLIND, PLACEBO-CONTROLLED</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Paraíba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Paraíba</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>
      Relating the electroencephalogram findings of patients with tinnitus before and after a&#xD;
      therapeutic modality is still scarce in the literature, especially with neuromodulatory&#xD;
      methods, more specifically with Transcranial Direct Current Stimulation - tDCS. This study is&#xD;
      a double blind, sham-controlled clinical trial aiming investigate the impact of tDCS on&#xD;
      patterns of brain electrical activity in patients with chronic tinnitus. 36 volunteers with&#xD;
      tinnitus will be allocated randomly in 2 groups: the first (n = 18) will receive anodic tDCS&#xD;
      in the temporoparietal left area and cathode in the right dorsolateral prefrontal cortex and&#xD;
      the second group (n = 18) correspond to the sham group. In addition, healthy individuals (n =&#xD;
      18) will be recruited for comparative purposes of brain electrical activity with and without&#xD;
      tinnitus, totaling 54 participants. Patients with tinnitus will receive transcranial direct&#xD;
      current stimulation for 20 minutes for 5 consecutive days (1 week) and will be assessed&#xD;
      before and after intervention by electroencephalogram, Acuphenometry, Visual Analogue Scale -&#xD;
      VAS and questionnaire Tinnitus Handicap Inventory- THI. Follow-up of volunteers will also be&#xD;
      performed after 1 month of the end of treatment with tDCS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2017</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2017</primary_completion_date>
  <phase>Phase 2</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>Tinnitus Handicap Inventory</measure>
    <time_frame>THI will be measured before intervention (baseline), after 5 daily sessions (day 5) and 1 month after the last intervention.</time_frame>
    <description>Assesses change in tinnitus from baseline to follow-up periods post interventions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress</measure>
    <time_frame>Visual analogue scale of tinnitus wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention.</time_frame>
    <description>Self assessment of tinnitus loudness and tinnitus distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acuphenometry</measure>
    <time_frame>Acufhenometry wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention.</time_frame>
    <description>Subjective assessment of the frequency, intensity and type of tinnitus.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Tinnitus</condition>
  <arm_group>
    <arm_group_label>Active tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive 20 minutes of active tDCS for five consecutive days, current of 2 mA, in the temporoparietal left area, and right prefrontal cortex.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects will receive 20 minutes of Sham tDCS for five consecutive days in the temporoparietal left area, and right prefrontal cortex.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Direct Current Stimulation</intervention_name>
    <description>Anodal stimulation of the temporoparietal left area with an cathode over the right dorsolateral prefrontal cortex. Stimulation will be applied for 20 minutes at 2 mA.</description>
    <arm_group_label>Active tDCS</arm_group_label>
    <other_name>Direct current stimulator; Transcranial stimulator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Transcranial Direct Current Stimulation</intervention_name>
    <description>Sham tDCS sessions will last 20 minutes</description>
    <arm_group_label>Sham tDCS</arm_group_label>
    <other_name>Sham stimulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of at least 18 years;&#xD;
&#xD;
          -  Chronic tinnitus for at least 6 months.&#xD;
&#xD;
          -  Age-adjusted normal (sensorineural) hearing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and/or lactation;&#xD;
&#xD;
          -  Concurrent treatment for tinnitus;&#xD;
&#xD;
          -  Prior exposure to transcranial direct current stimulation (tDCS);&#xD;
&#xD;
          -  History of epilepsy and/or seizures;&#xD;
&#xD;
          -  Electronic implants or metallic objects in body;&#xD;
&#xD;
          -  Skin conditions where electrodes will be applied;&#xD;
&#xD;
          -  Major neurological co-morbidities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dayse Souza</last_name>
    <email>dayse.s.s@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dayse Souza</name>
      <address>
        <city>Joao Pessoa</city>
        <state>PB</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Paraíba</investigator_affiliation>
    <investigator_full_name>Dayse da Silva Souza</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Tinnitus</keyword>
  <keyword>Electroencephalogram</keyword>
  <keyword>Transcranial Direct Current Stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinnitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03036137
org study id: 61192416.9.0000.5188
nct id: NCT03036137
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Relating the electroencephalogram findings of patients with tinnitus before and after a
      therapeutic modality is still scarce in the literature, especially with neuromodulatory
      methods, more specifically with Transcranial Direct Current Stimulation - tDCS. This study is
      a double blind, sham-controlled clinical trial aiming investigate the impact of tDCS on
      patterns of brain electrical activity in patients with chronic tinnitus. 36 volunteers with
      tinnitus will be allocated randomly in 2 groups: the first (n = 18) will receive anodic tDCS
      in the temporoparietal left area and cathode in the right dorsolateral prefrontal cortex and
      the second group (n = 18) correspond to the sham group. In addition, healthy individuals (n =
      18) will be recruited for comparative purposes of brain electrical activity with and without
      tinnitus, totaling 54 participants. Patients with tinnitus will receive transcranial direct
      current stimulation for 20 minutes for 5 consecutive days (1 week) and will be assessed
      before and after intervention by electroencephalogram, Acuphenometry, Visual Analogue Scale -
      VAS and questionnaire Tinnitus Handicap Inventory- THI. Follow-up of volunteers will also be
      performed after 1 month of the end of treatment with tDCS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Tinnitus Handicap Inventory
time frame: THI will be measured before intervention (baseline), after 5 daily sessions (day 5) and 1 month after the last intervention.
description: Assesses change in tinnitus from baseline to follow-up periods post interventions
measure: Visual Analogue Scales (VAS) of perceived tinnitus loudness and distress
time frame: Visual analogue scale of tinnitus wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention.
description: Self assessment of tinnitus loudness and tinnitus distress.
measure: Acuphenometry
time frame: Acufhenometry wiil be recorded at baseline (before intervention), before and after daily sessions with tDCS (day 1 to 5) , and 1 month after the last intervention.
description: Subjective assessment of the frequency, intensity and type of tinnitus.
arm group label: Active tDCS
arm group type: Active Comparator
description: Subjects will receive 20 minutes of active tDCS for five consecutive days, current of 2 mA, in the temporoparietal left area, and right prefrontal cortex.
arm group label: Sham tDCS
arm group type: Sham Comparator
description: Subjects will receive 20 minutes of Sham tDCS for five consecutive days in the temporoparietal left area, and right prefrontal cortex.
intervention type: Device
intervention name: Transcranial Direct Current Stimulation
description: Anodal stimulation of the temporoparietal left area with an cathode over the right dorsolateral prefrontal cortex. Stimulation will be applied for 20 minutes at 2 mA.
arm group label: Active tDCS
other name: Direct current stimulator; Transcranial stimulator
intervention type: Device
intervention name: Sham Transcranial Direct Current Stimulation
description: Sham tDCS sessions will last 20 minutes
arm group label: Sham tDCS
other name: Sham stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dayse Souza
email: dayse.s.s@hotmail.com
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Paraíba
investigator full name: Dayse da Silva Souza
investigator title: Principal Investigator
mesh term: Tinnitus
sharing ipd: No