Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment (MagTIN)

Civil Hospices of Lyon

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Tinnitus

Treatments: Device: Sham transcranial magnetic stimulator Medtronic © MagPro X100 (shielded figure-8 coil with fluid cooling); Device: transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling)

Study type: Interventional

Funder types: Other

Identifiers

NCT01407133

2004.365

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

Active rTMS

Experimental group

Description:

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).

Treatment:

Device: transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling)

Sham rTMS

Sham Comparator group

Description:

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)

Treatment:

Device: Sham transcranial magnetic stimulator Medtronic © MagPro X100 (shielded figure-8 coil with fluid cooling)