The effect of pregabalin on the success to reduce the interference by tinnitus by an extinction training is tested in chronic tinnitus sufferers.
Conditions
Interventions
Trade Name: Lyrica 75 mg
Product Name: LYRICA 75 mg hard capsules
Product Code: -
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Prof. Herta Flor, Head of the Institute of Clinical and Cognitive Neuroscience
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Twenty-eight patients with chronic (> 0.5 years) constant tinnitus participate in the study with two subgroups of 14 patients matched by age and gender. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: severe hearing loss, head or ear injury or operation, other outer or inner ear diseases, physical cause of tinnitus, major mental disorder according to DSM-IV-TR, centrally acting medication, neuropathic pain, epilepsy, pregnancy, galactose intolerance, lapp lactase deficiency, glucose galactose malabsorbtion, renal and nephrological insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - the development of a procedure to optimally tune the individually most effective auditory signal with regard to maximal residual inhibition within this training program, - to implement this procedure into a computer program easy to handle for patients ;Main Objective: - to test a training program for tinnitus patients that provides an auditory signal that induces residual inhibition (RI), trains the extension of residual inhibition by optimizing the length and duration of RI, and is designed to obtain extinction of the tinnitus percept and negative emotional responses, - to test the additive effects of the calcium channel blocker pregabalin vs. placebo on the training effects, - to assess effects of the training on habituation of the N100 of the electroencephalogram as well as the skin conductance response to tinnitus-like and control tones in addition to effects on tinnitus severity and interference and RI control ;Primary end point(s): The preparatio for the training study presumably starts in June 2006. After 3 months of preparation, and after individuals give informed consent, psychological and psychophysical assessments are performed. This group design is a multiple baseline design in which small groups of patients successively enter treatment 2, 4, 6, or 8 weeks after the diagnostic assessment thus providing variable waiting periods that will be used to assess tinnitus parameters. The medication will be given for 8 weeks in parallel to the auditory training procedure. We expect to collect data until 04-2006, data analyses will be approximately finished in the end of 5-2007. | — |
Countries
Germany
Outcome results
None listed