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A Randomized Controlled HD-tDCS Trial: Effects on Tinnitus Severity and Cognition

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ClinicalTrials.gov Identifier: NCT03754127
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Ethisch Comité, UZA, University Hospital, Antwerp

Brief Summary:
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.).

Condition or disease Intervention/treatment Phase
Tinnitus Device: tDCS Device: sham tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparative, Randomized Trial on HD-tDCS and Sham Control Group: Effects on Tinnitus Severity and Cognition Including Objective Measures.
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: Active group
tDCS
Device: tDCS
Transcranial direct current stimulation

Sham Comparator: Sham group
Sham tDCS
Device: sham tDCS
Sham transcranial direct current stimulation




Primary Outcome Measures :
  1. Tinnitus Functional Index [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Tinnitus Questionnaire (TQ) [ Time Frame: 3 months ]
    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).

  2. Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12) [ Time Frame: 3 months ]
    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.

  3. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3 months ]
    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).

  4. Visual Analogue Scale (VAS) [ Time Frame: 3 months ]
    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).

  5. Hyperacusis Questionnaire (HQ) [ Time Frame: 3 months ]
    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.

  6. Health Utility Index (HUI23) [ Time Frame: 3 months ]
    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).

  7. Big Five Inventory-2 (BFI2) [ Time Frame: 3 months ]
    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.

  8. Speech-in-quiet (SPIQ) and speech-in-noise (SPIN) understanding [ Time Frame: 3 months ]
  9. Repeatable Battery for the Assessment of Neuropsychological Status, adjusted to test Hearing impaired individuals (RBANS-H) [ Time Frame: 3 months ]
  10. Cortical Auditory Evoked Potentials (CAEP) [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Duration of tinnitus: > 6 months
  • 24 < TFI score < 90
  • HADS depression subscale < 12
  • HADS anxiety subscale < 12
  • Hyperacusis questionnaire < 40
  • Dutch- or Flemish-speaking

Exclusion Criteria:

  • Somatic tinnitus
  • Pregnancy
  • Active middle ear pathology
  • Hearing implants
  • Known tumors in the head/neck region
  • Patients having already had any other tinnitus treatment within the last 2 months

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): NCT03754127


Locations
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Belgium
Antwerp University Hospital Recruiting
Antwerp, Edegem, Belgium, 2650
Contact: Annick Gilles, PhD    32 821 32 57    nko@uza.be   
Principal Investigator: Annick Gilles, PhD         
Sub-Investigator: Vincent Van Rompaey, PhD         
Sub-Investigator: Paul Van de Heyning, PhD         
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ethisch Comité, UZA, Prof dr Annick Gilles (PhD), principal investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03754127     History of Changes
Other Study ID Numbers: EC 18/33/365
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 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 Ethisch Comité, UZA, University Hospital, Antwerp:
tinnitus
tdcs
neuromodulation
RCT
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms