Chronic Tinnitus
Conditions
Keywords
Neuro-otology, Chronic tinnitus, Sensory disability, Repetitive transcranial magnetic stimulation, Dose escalation
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.
Interventions
DEVICEtranscranial 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.
DEVICESham transcranial magnetic stimulator Medtronic © MagPro X100 (shielded figure-8 coil with fluid cooling)
Same sound level as active rTMS, but magnetic field strongly attenuated
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 | — |
| 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) | — |
| 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 | — |
Countries
France
Outcome results
None listed