Clinical trial NCT03754127: A Randomized Controlled HD-tDCS Trial: Effects on Tinnitus Severity and Cognition
Official title: A Comparative, Randomized Trial on HD-tDCS and Sham Control Group: Effects on Tinnitus Severity and Cognition Including Objective Measures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
tdcs
neuromodulation
RCT
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2018-11-27
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.).


Eligibility 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

Primary outcomes:
measure: Tinnitus Functional Index
timeFrame: 3 months
Secondary outcomes:
measure: Tinnitus Questionnaire (TQ)
timeFrame: 3 months
measure: Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12)
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months
measure: Visual Analogue Scale (VAS)
timeFrame: 3 months
measure: Hyperacusis Questionnaire (HQ)
timeFrame: 3 months
measure: Health Utility Index (HUI23)
timeFrame: 3 months
measure: Big Five Inventory-2 (BFI2)
timeFrame: 3 months
measure: Speech-in-quiet (SPIQ) and speech-in-noise (SPIN) understanding
timeFrame: 3 months
measure: Repeatable Battery for the Assessment of Neuropsychological Status, adjusted to test Hearing impaired individuals (RBANS-H)
timeFrame: 3 months
measure: Cortical Auditory Evoked Potentials (CAEP)
timeFrame: 3 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
state: Edegem
Study officials:
References:
citation: Cardon E, Van Rompaey V, Jacquemin L, Mertens G, Vermeersch H, Joossen I, Beyers J, Vanderveken OM, Van de Heyning P, Topsakal V, Gilles A. Sequential dual-site High-Definition transcranial Direct Current Stimulation (HD-tDCS) treatment in chronic subjective tinnitus: study protocol of a double-blind, randomized, placebo-controlled trial. Trials. 2019 Aug 1;20(1):471. doi: 10.1186/s13063-019-3594-y.