Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
NCT ID: NCT01407133
Last Updated: 2012-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
64 participants
INTERVENTIONAL
2005-05-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active rTMS
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).
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.
Sham rTMS
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)
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
Interventions
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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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Xavier PERROT, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Service d'Audiologie et Explorations Orofaciales (Pr. COLLET) - Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
Locations
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Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot
Lyon, , France
Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
Countries
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Other Identifiers
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2004.365
Identifier Type: -
Identifier Source: org_study_id