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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Experimental | 48 subjects will receive active temporal rTMS, applied with the following combined parameters:
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| Sham rTMS | Sham Comparator | 16 subjects will receive sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session (300 or 900) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in tinnitus perception, as measured over time using a visual analog rating scale (subjective loudness of tinnitus) | The time between enrollment and rTMS intervention will vary from one subject to another (expected average of 4 months); depending on the protocol, the end of the intervention corresponds to the end of week 1, 4, 5 or 20 (first day of rTMS as reference) | At subject enrollment; daily for 2 weeks before the intervention; before and after each rTMS session, once at the end of each week and at the end of intervention; during follow-up: twice a week for 6 months, and 1 year after the end of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of rTMS, evaluated through a semi-structured interview on specific and nonspecific adverse events | Depending on the protocol, the end of the intervention corresponds to the end of week 1, 4, 5 or 20 (first day of rTMS as reference) | After the first rTMS session; before and after each following session and at the end of intervention period; 1, 4 or 5, and 20 weeks after the start of intervention; 1, 3, 6 months and 1 year after the end of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier PERROT, MD, PhD | Service d'Audiologie et Explorations Orofaciales (Pr. COLLET) - Centre Hospitalier Lyon Sud - Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot | Lyon | 69437 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22405743 | Result | Tringali S, Perrot X, Collet L, Moulin A. Repetitive transcranial magnetic stimulation (rTMS) noise: a relevance for tinnitus treatment? Brain Stimul. 2012 Oct;5(4):655-6. doi: 10.1016/j.brs.2011.10.006. Epub 2012 Feb 22. No abstract available. | |
| 22872177 | Result | Tringali S, Perrot X, Collet L, Moulin A. Repetitive transcranial magnetic stimulation noise levels: methodological implications for tinnitus treatment. Otol Neurotol. 2012 Sep;33(7):1156-60. doi: 10.1097/MAO.0b013e318263d37d. |
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| Sham transcranial magnetic stimulator Medtronic © MagPro X100 (shielded figure-8 coil with fluid cooling) | Device | Same sound level as active rTMS, but magnetic field strongly attenuated |
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| Auditory status, evaluated through tonal audiometry (pure-tone average) | The time between enrollment and rTMS intervention will vary from one subject to another (expected average of 4 months) | At subject enrollment; before the first rTMS session and after the last rTMS session (for all types of protocols), and every five sessions of rTMS (for long protocols) |
| Change in severity of tinnitus, measured through a multidimensional self-questionnaire: Subjective Tinnitus Severity Scale (STSS) | Depending on the protocol, middle (respectively, end) of the intervention corresponds to day 3, day 12, beginning of week 3 or beginning of week 11 (respectively, end of week 1, 4, 5 or 20), with the first day of rTMS as reference | At subject enrollment; before the first rTMS session, in the middle and at the end of intervention period; 1, 4 or 5, and 20 weeks after the start of intervention; 1, 3, 6 months and 1 year after the end of intervention |
| Change in handicap related to tinnitus, measured through a multidimensional self-questionnaire: Tinnitus Handicap Questionnaire (THQ) | At subject enrollment; at the beginning, in the middle and at the end of rTMS intervention period; 1, 4 or 5, and 20 weeks after the start of intervention; 1, 3, 6 months and 1 year after the end of intervention |
| Change in hyperacusis, measured through a multidimensional self-questionnaire: Auditory Hypersensitivity Questionnaire | At subject enrollment; at the beginning, in the middle and at the end of rTMS intervention period; 1, 4 or 5, and 20 weeks after the start of intervention; 1, 3, 6 months and 1 year after the end of intervention |
| Change in anxiety and depression, measured through a two-dimensional self-questionnaire: Hospital Anxiety and Depression Scale (HADS) | At subject enrollment; at the beginning, in the middle and at the end of rTMS intervention period; 1, 4 or 5, and 20 weeks after the start of intervention; 1, 3, 6 months and 1 year after the end of intervention |
| Personality, assessed through a multidimensional self-questionnaire: Mini-Mult (short form of the MMPI) | The time between enrollment and rTMS intervention will vary from one subject to another (expected average of 4 months) | At subject enrollment |
| Change in tinnitus spectrum (loudness and pitch), characterized through psychoacoustical measurements: tinnitometry | At subject enrollment; at the beginning, in the middle and at the end of rTMS intervention period; 1, 4 or 5, and 20 weeks after the start of intervention; 1, 3, 6 months and 1 year after the end of intervention |
| Motivation level, assessed through a short self-questionnaire (Likert-type scale) | At the beginning of intervention period (before the first rTMS session) (day 1) |
| Satisfaction degree, assessed through a short self-questionnaire (Likert-type scale) Time Frame: At the end of SMTr intervention | At the end of intervention period (end of week 1, 4, 5 or 20, with the first day of rTMS as reference) |
| Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud |
| Pierre-Bénite |
| 69495 |
| France |
| Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud | Pierre-Bénite | 69495 | France |
| 21824837 | Result | Tringali S, Perrot X, Collet L, Moulin A. Repetitive transcranial magnetic stimulation: hearing safety considerations. Brain Stimul. 2012 Jul;5(3):354-363. doi: 10.1016/j.brs.2011.06.005. Epub 2011 Jul 26. |