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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT00567892
Eligibility Criteria:
On-line eligibility screening:
https://tinnitus.wustl.edu/
Inclusion Criteria:
* Men and women between the ages of 18 and 60 years.
* Subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater.
* Tinnitus Handicap Inventory (THI) score of 38 or greater.
* Subjects of child-bearing potential using an appropriate form of birth control acceptable to the research team and with a negative urine pregnancy test or undergone sterilization procedure.
* Able to give informed consent.
* Available for once daily therapy, during working hours, Mon.-Fri.
* English-speaking.
Exclusion Criteria:
* Patients experiencing tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone.
* Patients with hyperacusis or misophonia (hyper-sensitivity to loud noises).
* History of seizures, history of loss of consciousness requiring medical care, any other CNS pathology that increases a subject's risk for treatment with rTMS.
* Patients with cardiac pacemakers, intracardiac lines, implanted medication pumps, implanted electrodes in the brain, other intracranial metal objects with the exception of dental fillings, or any other contraindication for MRI scan.
* Any contraindication for receiving FDG PET, as determined by established clinical criteria.
* Patients with an acute or chronic unstable medical condition which, in the opinion of the investigator, would require stabilization prior to initiation of magnetic stimulation.
* Patients with any active ear disease that, in the opinion of the PI, needs to be further evaluated.
* Patients with symptoms of depression as evidenced by a score of 14 or greater on the Beck Depression Inventory or, in the opinion of the psychiatric sub-investigator demonstrates active mood symptoms that meet DSM-IV-TR criteria for Major Depressive Disorder.
* Any psychiatric co-morbidity that, in the opinion of the psychiatric sub-investigator, may complicate the interpretation of study results.
* Pregnancy
* Currently breast-feeding
* Previous treatment with rTMS
* Patients with tinnitus related to Workman's Compensation claim or litigation-related event.
* Patients with a history of diabetes.
* Fasting glucose \> 150mg/Dl.
* Patients taking any medication(s), in the opinion of the investigator, that is(are) deemed to be etiologically related to the development of tinnitus.
* Unable to elicit a motor threshold with rTMS.
* A Mini-Mental Status Exam score less than 27.
* Untreated or newly diagnosed hypertension, (systolic blood pressures above 140 mm or diastolic pressure above 90 mm).
* Patients with a history of claustrophobia.
* Inability to lay flat for 2 hours.
* Active alcohol and/or drug dependence or history of alcohol and/or ETOH dependence within the last year.
* Any medical condition that, in the opinion of the investigators, confounds study results or places the subject at greater risk.
* Unable to provide informed consent.
* Any exclusions from radiology screening for MRI or PET scanning.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00567892
Study Brief:
Protocol Section:
NCT00567892