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

July 5, 2022 updated by: ethisch.comite@uza.be, University Hospital, Antwerp

A Comparative, Randomized Trial on HD-tDCS and Sham Control Group: Effects on Tinnitus Severity and Cognition Including Objective Measures.

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.).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Edegem
      • Antwerp, Edegem, Belgium, 2650
        • Antwerp University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active group
tDCS
Device: tDCS
Transcranial direct current stimulation
Sham Comparator: Sham group
Sham tDCS
Device: sham tDCS
Sham transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
3 months
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 months
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).
3 months
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).
3 months
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.
3 months
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).
3 months
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.
3 months
Speech-in-quiet (SPIQ) and speech-in-noise (SPIN) understanding
Time Frame: 3 months
3 months
Repeatable Battery for the Assessment of Neuropsychological Status, adjusted to test Hearing impaired individuals (RBANS-H)
Time Frame: 3 months
3 months
Cortical Auditory Evoked Potentials (CAEP)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Antwerp

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universiteit Antwerpen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EC 18/33/365

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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