64
Participants
Start Date
May 31, 2005
Primary Completion Date
September 30, 2009
Study Completion Date
September 30, 2009
transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling)
"The study is based on a dual procedure consisting of comparisons between active and sham rTMS on the one hand and between four increasing levels of magnetic pseudo-dose on the other hand. Each level comprises 16 patients randomly assigned to active rTMS group (12 patients) or sham rTMS group (4 patients). The transition from one level to another is authorized by an independent oversight committee charged with checking the tolerability of rTMS sessions for the tested level. The neuronavigated rTMS use either active or sham figure-eight coil and is centered over the primary auditory cortex contralateral to the perceived predominant side of tinnitus. This target is located through anatomical brain MRI and neuronavigated brain system. According to the stimulation parameters, each rTMS session can last from 5 to 112 minutes and the whole rTMS intervention from 1 to 20 weeks. The follow-up is spread over twelve months."
Sham transcranial magnetic stimulator Medtronic © MagPro X100 (shielded figure-8 coil with fluid cooling)
Same sound level as active rTMS, but magnetic field strongly attenuated
Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot, Lyon
Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud, Pierre-Bénite
Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud, Pierre-Bénite
Hospices Civils de Lyon
OTHER