- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01407133
Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment (MagTIN)
August 9, 2012 updated by: Hospices Civils de Lyon
Assessment of Conventional Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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LYON Cedex 03, France, 69437
- Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot
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PIERRE-BÉNITE Cedex, France, 69495
- Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud
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PIERRE-BÉNITE Cedex, France, 69495
- Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Active rTMS
48 subjects will receive active temporal rTMS, applied with the following combined parameters:
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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 Names:
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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)
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Same sound level as active rTMS, but magnetic field strongly attenuated
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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)
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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)
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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
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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)
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The time between enrollment and rTMS intervention will vary from one subject to another (expected average of 4 months)
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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)
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Personality, assessed through a multidimensional self-questionnaire: Mini-Mult (short form of the MMPI)
Time Frame: At subject enrollment
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The time between enrollment and rTMS intervention will vary from one subject to another (expected average of 4 months)
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At subject enrollment
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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
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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
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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)
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At the beginning of intervention period (before the first rTMS session) (day 1)
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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)
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At the end of intervention period (end of week 1, 4, 5 or 20, with the first day of rTMS as reference)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xavier PERROT, MD, PhD, Service d'Audiologie et Explorations Orofaciales (Pr. COLLET) - Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
July 26, 2011
First Submitted That Met QC Criteria
August 1, 2011
First Posted (Estimate)
August 2, 2011
Study Record Updates
Last Update Posted (Estimate)
August 10, 2012
Last Update Submitted That Met QC Criteria
August 9, 2012
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004.365
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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