NCT01407133

Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Tinnitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-05-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2011-08-02
• Last updated: 2025-12-19

Locations

3 sites across 1 country: France