engleski

RTMS H7-COIL IN THE TREATMENT OF TINNITUS; META- ANALYSIS AND MODIFIED PROTOCOL

Introduction: A relatively large number of studies of the efficacy of rTMS on tinnitus have been conducted. LF stimulation of the auditory cortex in combination with HF stimulation of the DLPFC, has shown efficacy in reduction of symptoms (especially loudness and anxiety). H7-coil in stimulating auditory cortex and mPFC may be a possible alternative target for HF rTMS of the DLPFC. Objective: To launch a protocol to examine the efficacy of Cool-B65 coil LF rTMS combined with H7-deep coil HF rTMS, in the treatment of idiopathic, chronic, normo-acoustic tinnitus disorder, informed by the assessment of efficacy of rTMS on idiopathic, chronic tinnitus disorder. Hypothesis: The Cool-B65 coil LF rTMS (1Hz) placed over the auditory cortex combined with H7-deep coil HF rTMS (10Hz) placed over mPFC, applied for 15 days, has superior efficacy on tinnitus symptoms measured by the overall THI score, then the SHAM passive coil. Methodology/ study design: We first conducted a meta-analysis of randomized sham-controlled, double-blind trials to access the efficacy of rTMS on idiopathic, chronic tinnitus disorder. We are now planning an industry- independent, single-center, prospective, randomized sham-controlled, two-arms, double- blind superiority clinical trial with concealed allocation and masked independent outcome assessment. Population: Outpatients diagnosed for > 12 months and < 5 years with persistent, subjective, normo-acoustic tinnitus disorder of at least moderate severity defined by the THI score > 38, both unilateral and bilateral, both genders, and with no hearing loss, age 18-65 years, with the tinnitus treatment unchanged for at least one months. Exclusion criteria: organically caused tinnitus and organic brain lesion, objective tinnitus, severe hearing loss or Menier’s disease, middle ear disease, diagnosed mental disorder, suicidality, alcohol or drugs addictions, clinically relevant neurological disorder and standard rTMS exclusion criteria. Sample size: 52 in HR rTMS H7-coil arm, and 52 in sham control arm. Outcome: Adjusted median of differences in instruments measuring tinnitus, annoyance, distress, anxiety, and depression. Conclusion: We are conducting a theoretically founded study, with an empirically founded patient-oriented approach.

Tinnitus ; rTMS ; H7 ; dTMS

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