A Comparative, Randomized Trial on HD-tDCS and Sham Control Group: Effects on Tinnitus Severity and Cognition Including Objective Measures.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 81
- Locations
- 2
- Primary Endpoint
- Tinnitus Functional Index
Study Overview
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.).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- Speech-in-quiet (SPIQ) and speech-in-noise (SPIN) understanding(3 months)
- Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12)(3 months)
- Visual Analogue Scale (VAS)(3 months)
- Hyperacusis Questionnaire (HQ)(3 months)
- Big Five Inventory-2 (BFI2)(3 months)
- Cortical Auditory Evoked Potentials (CAEP)(3 months)
- Tinnitus Questionnaire (TQ)(3 months)
- Health Utility Index (HUI23)(3 months)
- Repeatable Battery for the Assessment of Neuropsychological Status, adjusted to test Hearing impaired individuals (RBANS-H)(3 months)
- Hospital Anxiety and Depression Scale (HADS)(3 months)
Investigators
ethisch.comite@uza.be
Prof dr Annick Gilles (PhD), principal investigator
University Hospital, Antwerp