Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT01407133
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01407133
Study Brief:
Protocol Section:
NCT01407133