Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
- 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)Device: Sham transcranial magnetic stimulator Medtronic © MagPro X100 (shielded figure-8 coil with fluid cooling)
- Registration Number
- NCT01407133
- Lead Sponsor
- Hospices Civils de Lyon
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active rTMS transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling) 48 subjects will receive active temporal rTMS, applied with the following combined parameters: * intensity: 100% of resting motor threshold * stimulation frequency: low-frequency continuous stimulation (0.5 or 1 Hz) or high-frequency stimulation trains (4 or 12 Hz) * number of stimulations per session: 300, 900 or 1800 per session * number of sessions per week: spaced out / low density protocol (1 per week) or dense / high density protocol (5 per week) * total number of sessions for the whole intervention: short protocol (5 sessions) or long protocol (20 sessions). Sham rTMS Sham transcranial magnetic stimulator Medtronic © MagPro X100 (shielded figure-8 coil with fluid cooling) 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)
- Primary Outcome Measures
Name Time Method Change from baseline in tinnitus perception, as measured over time using a visual analog rating scale (subjective loudness of tinnitus) 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 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)
- Secondary Outcome Measures
Name Time Method Tolerance of rTMS, evaluated through a semi-structured interview on specific and nonspecific adverse events 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 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)
Auditory status, evaluated through tonal audiometry (pure-tone average) 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) The time between enrollment and rTMS intervention will vary from one subject to another (expected average of 4 months)
Change in severity of tinnitus, measured through a multidimensional self-questionnaire: Subjective Tinnitus Severity Scale (STSS) 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 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
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) At subject enrollment The time between enrollment and rTMS intervention will vary from one subject to another (expected average of 4 months)
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)
Trial Locations
- Locations (3)
Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud
🇫🇷PIERRE-BÉNITE Cedex, France
Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud
🇫🇷PIERRE-BÉNITE Cedex, France
Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot
🇫🇷LYON Cedex 03, France