Tinnitus
Conditions
Keywords
tinnitus, piribedil, acoustic otoemissions, ECoG
Brief summary
Tinnitus is defined as the perception of sound in the absence of a external source. About 15 % of the population is believed to experience tinnitus and for about 20 % of them it may become a very serious problem. Total comprehension of tinnitus pathophysiology has not yet been achieved, but modern theories focus in brain hyperactivity following inner ear damage, with involvement of various neurotransmitters. Piribedil,a dopamin agonist, has been used to treat tinnitus, focusing in dopamine release, which is inhibitory. Electrophysiological methods,like acoustic otoemissions and electrocochleography may reveal the changes in peripherical and central auditory pathways and help to choose the specific patients who could benefit from piribedil treatment.
Interventions
DRUGpiribedil
50 mg once a day, after lunch 3 month therapy
Sponsors
Faculdade de Medicina de Valenca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* tinnitus for more than 6 months * THI \> 38 * no central acting drugs in the last 6 months * tympanogram type A-n
Exclusion criteria
* vascular and muscular tinnitus * concomitant TMJ disorders * abnormal otoscopy * mixed and conductive hearing losses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| THI - Tinnitus Handicap Inventory | Months 3 and 6 |
Secondary
| Measure | Time frame |
|---|---|
| VAS - Visual Analog Scale | Months 3 and 6 |
Countries
Brazil
Outcome results
None listed