- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03754127
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
Study Type
Interventional
Enrollment (Actual)
81
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: Active group
tDCS
|
Transcranial direct current stimulation
|
Sham Comparator: Sham group
Sham tDCS
|
Sham transcranial direct current stimulation
|
What is the study measuring?
Primary Outcome Measures
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
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
Collaborators
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.
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)
January 1, 2019
Primary Completion (Actual)
December 22, 2021
Study Completion (Actual)
March 30, 2022
Study Registration Dates
First Submitted
November 22, 2018
First Submitted That Met QC Criteria
November 26, 2018
First Posted (Actual)
November 27, 2018
Study Record Updates
Last Update Posted (Actual)
July 6, 2022
Last Update Submitted That Met QC Criteria
July 5, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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