Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions
Chronic Tinnitus
Interventions
DEVICE

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."

DEVICE

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

Trial Locations (3)

69437

Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot, Lyon

69495

Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud, Pierre-Bénite

Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud, Pierre-Bénite

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT01407133 - Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment | Biotech Hunter | Biotech Hunter