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

Antwerp University Hospital (UZA)

Status

Completed

Conditions

Tinnitus

Treatments

Device: tDCS

Device: sham tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT03754127

EC 18/33/365

Details and patient eligibility

About

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.).

Enrollment

81 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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