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Chronic TinnitusPhase 1/2MagTINNCT01407133

Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

A Phase 1/2 study testing transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling) in people with Chronic Tinnitus, run by Hospices Civils de Lyon at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Tinnitus
What is being tested?
transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
3 sitesFrance
Study dates
May 2005to Sep 2009
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Département d'ORL et de Chirurgie Cervico-Maxillo-Faciale, Hôpital Edouard Herriot

    Lyon, 69437

  • Service d'Audiologie et Explorations Orofaciales, Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Service d'Oto-Rhino-Laryngologie, Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

Other trials in France

About this study

Official title: 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.

Being tested
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)
Keywords
Neuro-otology, Chronic tinnitus, Sensory disability, Repetitive transcranial magnetic stimulation, Dose escalation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling)Device

    Also called 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)Device

    Also called Medtronic © MagPro X100 (with MagOption) stimulator and Placebo Butterfly Coil MCF-P-B65 (shielded figure-8 coil with fluid cooling)

    Same sound level as active rTMS, but magnetic field strongly attenuated

Study groups in NCT01407133
Study groupRoleWhat they receive
Active rTMSExperimental48 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).
Receives: Device: transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling)
Sham rTMSSham comparator16 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)
Receives: Device: Sham transcranial magnetic stimulator Medtronic © MagPro X100 (shielded figure-8 coil with fluid cooling)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 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 (10)

  1. 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)

    Measured: 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

  2. 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)

    Measured: 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)

  3. 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

    Measured: 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

  4. Change in handicap related to tinnitus, measured through a multidimensional self-questionnaire: Tinnitus Handicap Questionnaire (THQ)

    Measured: 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

  5. Change in hyperacusis, measured through a multidimensional self-questionnaire: Auditory Hypersensitivity Questionnaire

    Measured: 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

  6. Change in anxiety and depression, measured through a two-dimensional self-questionnaire: Hospital Anxiety and Depression Scale (HADS)

    Measured: 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

  7. 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)

    Measured: At subject enrollment

  8. Change in tinnitus spectrum (loudness and pitch), characterized through psychoacoustical measurements: tinnitometry

    Measured: 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

  9. Motivation level, assessed through a short self-questionnaire (Likert-type scale)

    Measured: At the beginning of intervention period (before the first rTMS session) (day 1)

  10. Satisfaction degree, assessed through a short self-questionnaire (Likert-type scale) Time Frame: At the end of SMTr intervention

    Measured: At the end of intervention period (end of week 1, 4, 5 or 20, with the first day of rTMS as reference)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2011 (estimated)
  2. Study startMay 2005
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01407133
Sponsor's protocol ID
2004.365
Acronym
MagTIN
Status last verified
Dec 2025
First submitted
26 Jul 2011
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No

Publications

  • Tringali S, Perrot X, Collet L, Moulin A. Repetitive transcranial magnetic stimulation (rTMS) noise: a relevance for tinnitus treatment? Brain Stimul. 2012 Oct;5(4):655-6. doi: 10.1016/j.brs.2011.10.006. Epub 2012 Feb 22. No abstract available.

    PubMed 22405743

  • Tringali S, Perrot X, Collet L, Moulin A. Repetitive transcranial magnetic stimulation noise levels: methodological implications for tinnitus treatment. Otol Neurotol. 2012 Sep;33(7):1156-60. doi: 10.1097/MAO.0b013e318263d37d.

    PubMed 22872177

  • Tringali S, Perrot X, Collet L, Moulin A. Repetitive transcranial magnetic stimulation: hearing safety considerations. Brain Stimul. 2012 Jul;5(3):354-363. doi: 10.1016/j.brs.2011.06.005. Epub 2011 Jul 26.

    PubMed 21824837

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling) in people with Chronic Tinnitus, run by Hospices Civils de Lyon at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01407133, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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