<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/NCT03754127</url>
  </required_header>
  <id_info>
    <org_study_id>EC 18/33/365</org_study_id>
    <nct_id>NCT03754127</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled HD-tDCS Trial: Effects on Tinnitus Severity and Cognition</brief_title>
  <official_title>A Comparative, Randomized Trial on HD-tDCS and Sham Control Group: Effects on Tinnitus Severity and Cognition Including Objective Measures.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universiteit Antwerpen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Antwerp</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This randomized, placebo-controlled study will compare the effects of HD-tDCS (a non-invasive&#xD;
      neuromodulation technique) with a sham stimulation. In the sham situation, patients will&#xD;
      undergo an identical treatment but no stimulation will be applied, allowing to control for&#xD;
      placebo effects. This study will assess the effects of HD-tDCS on chronic, non-pulsatile&#xD;
      tinnitus in a reliable way, as confounding factors such as anxiety, depression, hearing&#xD;
      impairment, tinnitus gradation, age, and sex will be controlled for. Ultimately, this study&#xD;
      will result in final recommendations for a standardised protocol for the use of HD-tDCS in&#xD;
      tinnitus patients. When accurate, individualised, and effective therapy is available for the&#xD;
      patient, the total cost (both economical and personal) will decrease significantly. The&#xD;
      investigation's findings will be relevant for all caretakers dealing with tinnitus patients&#xD;
      (psychologists, psychiatrists, manual therapists, general practitioners, ENT specialists,&#xD;
      audiologists, etc.).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">March 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 22, 2021</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tinnitus Functional Index</measure>
    <time_frame>3 months</time_frame>
    <description>The Tinnitus Functional Index (TFI) is a self-reported questionnaire, consisting of 25 questions, assessing the impact of tinnitus on patients' daily lives. The patient answers each question on a Likert scale ranging from 0 to 10. Questions 1 and 3 are expressed in percentages, and the Likert scale ranges from 0% to 100% (they are transformed to a 0-10 scale). The total score is then calculated as the mean of all questions multiplied by 10 to express this as a number between 0 and 100. In addition to the total score, the score of eight subscales can be determined. The subscales are the following: intrusiveness, reduced sense of control, cognitive interference, sleep disturbance, auditory difficulties attributed to tinnitus, interference with relaxation, reduced quality of life and emotional distress. A decrease of 13 points on the scale is considered as a clinical relevant difference.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tinnitus Questionnaire (TQ)</measure>
    <time_frame>3 months</time_frame>
    <description>The Dutch validated version of the TQ is used to differentiate between emotional and cognitive distress, auditory difficulties, and self-experienced intrusiveness caused by the tinnitus. The total score can range from 0 to 84, assigning a subject to a distress category: slight (score = 0 - 30, grade 1), moderate (score = 31 - 46, grade 2), severe (score = 47 - 59, grade 3) and very severe (score = 60 - 84, grade 4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12)</measure>
    <time_frame>3 months</time_frame>
    <description>The SSQ12 is a short form of the Speech, Spatial and Qualities of Hearing scale. It is developed for use in clinical research and rehabilitation settings to measure a range of hearing disabilities across several domains such as speech in noise, speech in quiet, localization, distance and movement, segregation and listening effort. Responders rate their ability to do or experience the situation described in each question by marking a 1-10 scale (1 = not at all, 10 = perfectly). Scores of all 12 questions are averaged to obtain a global SSQ-12 score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>3 months</time_frame>
    <description>To detect states of depression and anxiety the Hospital Anxiety and Depression Scale (HADS) is used. This self-assessment questionnaire consists of seven items in the subscale 'depression' and seven items in the subscale 'anxiety' and distinguishes clearly between both emotional disorders. The HADS serves as a screening tool for depression and anxiety. Scores of 7 or less on each subscale indicate non-cases. Scores of 8-10 are borderline abnormal (borderline case), while scores of 11-21 are abnormal (case).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>3 months</time_frame>
    <description>The patient scores the mean and maximum loudness of their tinnitus on a scale of 0 (absence of tinnitus) to 10 (as loud as possible, cannot be any louder).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hyperacusis Questionnaire (HQ)</measure>
    <time_frame>3 months</time_frame>
    <description>The HQ is a 14-item questionnaire that surveys a patient's hypersensitivity to sound. The 14 questions assess three dimensions (attentional, social, and emotional). The answer categories are: &quot;no&quot; (score of 0 points), &quot;yes, a little&quot; (1 point), &quot;yes, quite a lot&quot; (2 points), and &quot;yes, a lot&quot; (3 points). A total score of 28 or more indicates clinically significant hyperacusis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Utility Index (HUI23)</measure>
    <time_frame>3 months</time_frame>
    <description>The Health Utilities Index (HUI) is a family of generic health profiles and preference-based systems for the purposes of measuring health status, reporting health-related quality-of-life (QOL), and producing utility scores. The HUI comprises a 15-item questionnaire. The resulting total health-related QOL score ranges from 0.00 (dead) to 1.00 (perfect health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Big Five Inventory-2 (BFI2)</measure>
    <time_frame>3 months</time_frame>
    <description>The BFI2 comprises 60 statements to which subjects can assign a score ranging from 1 ('Disagree strongly') to 5 ('Agree strongly'). Each question belongs to one of the following 'Big Five' personality domains: Extraversion, Agreeableness, Conscientiousness, Negative Emotionality, and Open-Mindedness. For each domain, scores can vary from 12 to 60.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speech-in-quiet (SPIQ) and speech-in-noise (SPIN) understanding</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeatable Battery for the Assessment of Neuropsychological Status, adjusted to test Hearing impaired individuals (RBANS-H)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortical Auditory Evoked Potentials (CAEP)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Tinnitus</condition>
  <arm_group>
    <arm_group_label>Active group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tDCS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham tDCS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>Transcranial direct current stimulation</description>
    <arm_group_label>Active group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham tDCS</intervention_name>
    <description>Sham transcranial direct current stimulation</description>
    <arm_group_label>Sham group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Duration of tinnitus: &gt; 6 months&#xD;
&#xD;
          -  24 &lt; TFI score &lt; 90&#xD;
&#xD;
          -  HADS depression subscale &lt; 12&#xD;
&#xD;
          -  HADS anxiety subscale &lt; 12&#xD;
&#xD;
          -  Hyperacusis questionnaire &lt; 40&#xD;
&#xD;
          -  Dutch- or Flemish-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Somatic tinnitus&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Active middle ear pathology&#xD;
&#xD;
          -  Hearing implants&#xD;
&#xD;
          -  Known tumors in the head/neck region&#xD;
&#xD;
          -  Patients having already had any other tinnitus treatment within the last 2 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Antwerp</city>
        <state>Edegem</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>July 5, 2022</last_update_submitted>
  <last_update_submitted_qc>July 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Antwerp</investigator_affiliation>
    <investigator_full_name>ethisch.comite@uza.be</investigator_full_name>
    <investigator_title>Prof dr Annick Gilles (PhD), principal investigator</investigator_title>
  </responsible_party>
  <keyword>tinnitus</keyword>
  <keyword>tdcs</keyword>
  <keyword>neuromodulation</keyword>
  <keyword>RCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tinnitus</mesh_term>
  </condition_browse>
  <!-- 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/NCT03754127
org study id: EC 18/33/365
nct id: NCT03754127
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized, placebo-controlled study will compare the effects of HD-tDCS (a non-invasive
      neuromodulation technique) with a sham stimulation. In the sham situation, patients will
      undergo an identical treatment but no stimulation will be applied, allowing to control for
      placebo effects. This study will assess the effects of HD-tDCS on chronic, non-pulsatile
      tinnitus in a reliable way, as confounding factors such as anxiety, depression, hearing
      impairment, tinnitus gradation, age, and sex will be controlled for. Ultimately, this study
      will result in final recommendations for a standardised protocol for the use of HD-tDCS in
      tinnitus patients. When accurate, individualised, and effective therapy is available for the
      patient, the total cost (both economical and personal) will decrease significantly. The
      investigation's findings will be relevant for all caretakers dealing with tinnitus patients
      (psychologists, psychiatrists, manual therapists, general practitioners, ENT specialists,
      audiologists, etc.).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Tinnitus Functional Index
time frame: 3 months
description: The Tinnitus Functional Index (TFI) is a self-reported questionnaire, consisting of 25 questions, assessing the impact of tinnitus on patients' daily lives. The patient answers each question on a Likert scale ranging from 0 to 10. Questions 1 and 3 are expressed in percentages, and the Likert scale ranges from 0% to 100% (they are transformed to a 0-10 scale). The total score is then calculated as the mean of all questions multiplied by 10 to express this as a number between 0 and 100. In addition to the total score, the score of eight subscales can be determined. The subscales are the following: intrusiveness, reduced sense of control, cognitive interference, sleep disturbance, auditory difficulties attributed to tinnitus, interference with relaxation, reduced quality of life and emotional distress. A decrease of 13 points on the scale is considered as a clinical relevant difference.
measure: Tinnitus Questionnaire (TQ)
time frame: 3 months
description: The Dutch validated version of the TQ is used to differentiate between emotional and cognitive distress, auditory difficulties, and self-experienced intrusiveness caused by the tinnitus. The total score can range from 0 to 84, assigning a subject to a distress category: slight (score = 0 - 30, grade 1), moderate (score = 31 - 46, grade 2), severe (score = 47 - 59, grade 3) and very severe (score = 60 - 84, grade 4).
measure: Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12)
time frame: 3 months
description: The SSQ12 is a short form of the Speech, Spatial and Qualities of Hearing scale. It is developed for use in clinical research and rehabilitation settings to measure a range of hearing disabilities across several domains such as speech in noise, speech in quiet, localization, distance and movement, segregation and listening effort. Responders rate their ability to do or experience the situation described in each question by marking a 1-10 scale (1 = not at all, 10 = perfectly). Scores of all 12 questions are averaged to obtain a global SSQ-12 score.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: 3 months
description: To detect states of depression and anxiety the Hospital Anxiety and Depression Scale (HADS) is used. This self-assessment questionnaire consists of seven items in the subscale 'depression' and seven items in the subscale 'anxiety' and distinguishes clearly between both emotional disorders. The HADS serves as a screening tool for depression and anxiety. Scores of 7 or less on each subscale indicate non-cases. Scores of 8-10 are borderline abnormal (borderline case), while scores of 11-21 are abnormal (case).
measure: Visual Analogue Scale (VAS)
time frame: 3 months
description: The patient scores the mean and maximum loudness of their tinnitus on a scale of 0 (absence of tinnitus) to 10 (as loud as possible, cannot be any louder).
measure: Hyperacusis Questionnaire (HQ)
time frame: 3 months
description: The HQ is a 14-item questionnaire that surveys a patient's hypersensitivity to sound. The 14 questions assess three dimensions (attentional, social, and emotional). The answer categories are: "no" (score of 0 points), "yes, a little" (1 point), "yes, quite a lot" (2 points), and "yes, a lot" (3 points). A total score of 28 or more indicates clinically significant hyperacusis.
measure: Health Utility Index (HUI23)
time frame: 3 months
description: The Health Utilities Index (HUI) is a family of generic health profiles and preference-based systems for the purposes of measuring health status, reporting health-related quality-of-life (QOL), and producing utility scores. The HUI comprises a 15-item questionnaire. The resulting total health-related QOL score ranges from 0.00 (dead) to 1.00 (perfect health).
measure: Big Five Inventory-2 (BFI2)
time frame: 3 months
description: The BFI2 comprises 60 statements to which subjects can assign a score ranging from 1 ('Disagree strongly') to 5 ('Agree strongly'). Each question belongs to one of the following 'Big Five' personality domains: Extraversion, Agreeableness, Conscientiousness, Negative Emotionality, and Open-Mindedness. For each domain, scores can vary from 12 to 60.
measure: Speech-in-quiet (SPIQ) and speech-in-noise (SPIN) understanding
time frame: 3 months
measure: Repeatable Battery for the Assessment of Neuropsychological Status, adjusted to test Hearing impaired individuals (RBANS-H)
time frame: 3 months
measure: Cortical Auditory Evoked Potentials (CAEP)
time frame: 3 months
arm group label: Active group
arm group type: Experimental
description: tDCS
arm group label: Sham group
arm group type: Sham Comparator
description: Sham tDCS
intervention type: Device
intervention name: tDCS
description: Transcranial direct current stimulation
arm group label: Active group
intervention type: Device
intervention name: sham tDCS
description: Sham transcranial direct current stimulation
arm group label: Sham group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Antwerp
investigator full name: ethisch.comite@uza.be
investigator title: Prof dr Annick Gilles (PhD), principal investigator
mesh term: Tinnitus