Clinical trial NCT01407133: Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
Official title: Assessment of Conventional Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Tinnitus
Keywords: Neuro-otology
Chronic tinnitus
Sensory disability
Repetitive transcranial magnetic stimulation
Dose escalation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2011-08-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in tinnitus perception, as measured over time using a visual analog rating scale (subjective loudness of tinnitus)
timeFrame: 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
Secondary outcomes:
measure: Tolerance of rTMS, evaluated through a semi-structured interview on specific and nonspecific adverse events
timeFrame: 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
measure: Auditory status, evaluated through tonal audiometry (pure-tone average)
timeFrame: 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)
measure: Change in severity of tinnitus, measured through a multidimensional self-questionnaire: Subjective Tinnitus Severity Scale (STSS)
timeFrame: 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
measure: Change in handicap related to tinnitus, measured through a multidimensional self-questionnaire: Tinnitus Handicap Questionnaire (THQ)
timeFrame: 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
measure: Change in hyperacusis, measured through a multidimensional self-questionnaire: Auditory Hypersensitivity Questionnaire
timeFrame: 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
measure: Change in anxiety and depression, measured through a two-dimensional self-questionnaire: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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
measure: Personality, assessed through a multidimensional self-questionnaire: Mini-Mult (short form of the MMPI)
timeFrame: At subject enrollment
measure: Change in tinnitus spectrum (loudness and pitch), characterized through psychoacoustical measurements: tinnitometry
timeFrame: 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
measure: Motivation level, assessed through a short self-questionnaire (Likert-type scale)
timeFrame: At the beginning of intervention period (before the first rTMS session) (day 1)
measure: Satisfaction degree, assessed through a short self-questionnaire (Likert-type scale) Time Frame: At the end of SMTr intervention
timeFrame: At the end of intervention period (end of week 1, 4, 5 or 20, with the first day of rTMS as reference)
Other outcomes:
Locations:
city: LYON Cedex 03
country: France
facility: Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot
city: PIERRE-BÉNITE Cedex
country: France
facility: Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud
city: PIERRE-BÉNITE Cedex
country: France
facility: Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud
Study officials:
affiliation: Service d'Audiologie et Explorations Orofaciales (Pr. COLLET) - Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
name: Xavier PERROT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: