Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

Assessment of Conventional Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus

The objective of the investigators study is to assess conventional repetitive transcranial magnetic stimulation (rTMS) in patients with chronic severe tinnitus. A randomized, double-blind, sham-controlled procedure, with four increasing levels of magnetic "pseudo-dose" has been designed, in order to characterize the effectiveness of rTMS while controlling its safety and tolerability. By combining various rTMS protocols with a twelve-month follow-up, and using an effect modeling, the study aims at: (i) specify the effective values of rTMS parameters, with an adequate tolerance; (ii) determine the expected benefit and the persistence of effect; (iii) assess the practical feasibility of this kind of therapeutic management.

Inclusion Criteria:

• Men and women between the ages of 18 and 75 years old;
• Adequate medical condition (ASA P1 or P2 in Physical Status Classification System);
• Disabling tinnitus (STSS > 8/16 or THQ > 50%), with the following characteristics: continuous, subjective, non-pulsatile; unilateral (or bilateral with unilateral predominance), chronic (duration for at least one year), refractory for usual treatments taken for at least six months;
• Naive regarding TMS;
• Able to provide informed consent.

Exclusion Criteria:

• Objective tinnitus or tinnitus with treatable cause;
• Presence of intracranial or intraocular ferromagnetic materiel or particles (with the exception of dental fillings and MRI-compatible stapedectomy prosthesis);
• Cardiac pacemaker or other electronic implants (including cochlear implant);
• Serious heart disease or other unstable major medical condition;
• Personal history of central nervous system disorder, head injury, stroke or seizures (including childhood febrile seizures);
• Familial history of epilepsy;
• Concomitant medication with antidepressants and antipsychotics;
• Possibility of pregnancy;
• Known claustrophobia;
• Others known contraindications to rTMS or brain MRI;
• Refusal to be informed about the results of anatomical MRI