Back to resultsConventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment (MagTIN)
Primary Purpose
Chronic Tinnitus
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling)
Sham transcranial magnetic stimulator Medtronic © MagPro X100 (shielded figure-8 coil with fluid cooling)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Tinnitus focused on measuring Neuro-otology, Chronic tinnitus, Sensory disability, Repetitive transcranial magnetic stimulation, Dose escalation
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
Sites / Locations
- Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot
- Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud
- Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active rTMS
Sham rTMS
Arm 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).
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)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
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
Change in handicap related to tinnitus, measured through a multidimensional self-questionnaire: Tinnitus Handicap Questionnaire (THQ)
Change in hyperacusis, measured through a multidimensional self-questionnaire: Auditory Hypersensitivity Questionnaire
Change in anxiety and depression, measured through a two-dimensional self-questionnaire: Hospital Anxiety and Depression Scale (HADS)
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)
Change in tinnitus spectrum (loudness and pitch), characterized through psychoacoustical measurements: tinnitometry
Motivation level, assessed through a short self-questionnaire (Likert-type scale)
Satisfaction degree, assessed through a short self-questionnaire (Likert-type scale) Time Frame: At the end of SMTr intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01407133
Brief Title
Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
Acronym
MagTIN
Official Title
Assessment of Conventional Repetitive Transcranial Magnetic Stimulation for the Treatment of Chronic Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tinnitus
Keywords
Neuro-otology, Chronic tinnitus, Sensory disability, Repetitive transcranial magnetic stimulation, Dose escalation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active rTMS
Arm Type
Experimental
Arm 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).
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm 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)
Intervention Type
Device
Intervention Name(s)
transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling)
Other Intervention Name(s)
Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham transcranial magnetic stimulator Medtronic © MagPro X100 (shielded figure-8 coil with fluid cooling)
Other Intervention Name(s)
Medtronic © MagPro X100 (with MagOption) stimulator and Placebo Butterfly Coil MCF-P-B65 (shielded figure-8 coil with fluid cooling)
Intervention Description
Same sound level as active rTMS, but magnetic field strongly attenuated
Primary Outcome Measure Information:
Title
Change from baseline in tinnitus perception, as measured over time using a visual analog rating scale (subjective loudness of tinnitus)
Description
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)
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
Secondary Outcome Measure Information:
Title
Tolerance of rTMS, evaluated through a semi-structured interview on specific and nonspecific adverse events
Description
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)
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
Title
Auditory status, evaluated through tonal audiometry (pure-tone average)
Description
The time between enrollment and rTMS intervention will vary from one subject to another (expected average of 4 months)
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)
Title
Change in severity of tinnitus, measured through a multidimensional self-questionnaire: Subjective Tinnitus Severity Scale (STSS)
Description
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
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
Title
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
Title
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
Title
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
Title
Personality, assessed through a multidimensional self-questionnaire: Mini-Mult (short form of the MMPI)
Description
The time between enrollment and rTMS intervention will vary from one subject to another (expected average of 4 months)
Time Frame
At subject enrollment
Title
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
Title
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)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier PERROT, MD, PhD
Organizational Affiliation
Service d'Audiologie et Explorations Orofaciales (Pr. COLLET) - Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot
City
LYON Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud
City
PIERRE-BÉNITE Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud
City
PIERRE-BÉNITE Cedex
ZIP/Postal Code
69495
Country
France
12. IPD Sharing Statement
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Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
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