Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment (MagTIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01407133
First received: July 26, 2011
Last updated: August 9, 2012
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Chronic Tinnitus
Device: transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling)
Device: Sham transcranial magnetic stimulator Medtronic © MagPro X100 (shielded figure-8 coil with fluid cooling)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Conventional Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Change from baseline in tinnitus perception, as measured over time using a visual analog rating scale (subjective loudness of tinnitus) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Tolerance of rTMS, evaluated through a semi-structured interview on specific and nonspecific adverse events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 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) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 handicap related to tinnitus, measured through a multidimensional self-questionnaire: Tinnitus Handicap Questionnaire (THQ) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Change in hyperacusis, measured through a multidimensional self-questionnaire: Auditory Hypersensitivity Questionnaire [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Change in anxiety and depression, measured through a two-dimensional self-questionnaire: Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Personality, assessed through a multidimensional self-questionnaire: Mini-Mult (short form of the MMPI) [ Time Frame: At subject enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Motivation level, assessed through a short self-questionnaire (Likert-type scale) [ Time Frame: At the beginning of intervention period (before the first rTMS session) (day 1) ] [ Designated as safety issue: No ]
  • Satisfaction degree, assessed through a short self-questionnaire (Likert-type scale) Time Frame: At the end of SMTr intervention [ Time Frame: At the end of intervention period (end of week 1, 4, 5 or 20, with the first day of rTMS as reference) ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: May 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
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.
Other Name: Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling)
Sham Comparator: 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)
Device: 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 Name: Medtronic © MagPro X100 (with MagOption) stimulator and Placebo Butterfly Coil MCF-P-B65 (shielded figure-8 coil with fluid cooling)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407133

Locations
France
Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot
LYON Cedex 03, France, 69437
Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud
PIERRE-BÉNITE Cedex, France, 69495
Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud
PIERRE-BÉNITE Cedex, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Xavier PERROT, MD, PhD Service d'Audiologie et Explorations Orofaciales (Pr. COLLET) - Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01407133     History of Changes
Other Study ID Numbers: 2004.365
Study First Received: July 26, 2011
Last Updated: August 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Neuro-otology
Chronic tinnitus
Sensory disability
Repetitive transcranial magnetic stimulation
Dose escalation

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014