Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

Chronic Tinnitus Clinical Trial

— MagTIN  

Official title:

Assessment of Conventional Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407133
• Other study ID #: 2004.365
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 26, 2011
• Last updated: August 9, 2012
• Start date: May 2005
• Est. completion date: September 2009

Study information

• Verified date: July 2011
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Tinnitus
• Tinnitus

Intervention

Device:
• 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

Locations

Country	Name	City	State
France	Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot	LYON Cedex 03
France	Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud	PIERRE-BÉNITE Cedex
France	Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud	PIERRE-BÉNITE Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in tinnitus perception, as measured over time using a visual analog rating scale (subjective loudness of tinnitus)	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)	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	No
Secondary	Tolerance of rTMS, evaluated through a semi-structured interview on specific and nonspecific adverse events	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)	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	Yes
Secondary	Auditory status, evaluated through tonal audiometry (pure-tone average)	The time between enrollment and rTMS intervention will vary from one subject to another (expected average of 4 months)	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)	Yes
Secondary	Change in severity of tinnitus, measured through a multidimensional self-questionnaire: Subjective Tinnitus Severity Scale (STSS)	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	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Personality, assessed through a multidimensional self-questionnaire: Mini-Mult (short form of the MMPI)	The time between enrollment and rTMS intervention will vary from one subject to another (expected average of 4 months)	At subject enrollment	No
Secondary	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	No
Secondary	Motivation level, assessed through a short self-questionnaire (Likert-type scale)		At the beginning of intervention period (before the first rTMS session) (day 1)	No
Secondary	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)	No