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:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT02053961
Eligibility Criteria:
Inclusion Criteria:
1. Men and women aged 20-70.
2. Self-report of tinnitus in one or both ears, persisting for over a year, with no other hearing impairment.
3. Mild/moderate/severe tinnitus. Severity of tinnitus will be diagnosed using the TQ (Goebel \& Hiller) / the THI (Newman \& Jacobson).
4. Unresponsive to standard tinnitus medication.
5. Normal results on pure tone audiometry testing (threshold ≤ 25 dB hearing level in all frequencies from 250 to 8000 Hz).
6. Normal middle ear status was demonstrated by tympanometry, stapedius reflex tests, and otoscopy.
7. Normal results on neurological and physiological examinations.
8. Gave their oral and written consent to participate in the trial.
Exclusion Criteria:
1. A DSM-IV Axis-I psychiatric disorder.
2. Use of medication that may be a risk factor for seizures, such as:
antipsychotic medication; high dosage of antidepressant medication; drugs belonging to benzodiazepine class will be permitted if necessary at daily doses up to the equivalent of 2 mg Lorazepam (Lorivan)' any other drug that is considered a risk factor for seizures by the Principal Investigator.
3. History of intolerance to TMS.
4. Diagnosis of a severe personality disorder according to the DSM-IV.
5. Current suicidal ideation.
6. Uncontrolled hypertension.
7. History of epilepsy, seizure, or heat convulsion.
8. History of epilepsy or seizure in first degree relatives.
9. History of head injury or stroke.
10. History of any metallic particles in the head (except dental fillings).
11. History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemakers, cochlear implants, use of neurostimulators, or any medical pumps.
12. History of drug or alcohol abuse.
13. Inability to communicate adequately with examiner.
14. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
15. Inability to sign a consent form.
16. Pregnancy or inadequate birth control.
17. Severe hearing impairment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02053961
Study Brief:
Protocol Section:
NCT02053961