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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT01962558
Eligibility Criteria:
Inclusion Criteria:
1. 22 to 65 years of age
2. Have been diagnosed as suffering from sensorineural tinnitus and at least some tonal quality of the tinnitus
3. Unilateral or bilateral tinnitus
4. Have experienced tinnitus for at least one year and failed at least one tinnitus therapy (such as a counseling or sound therapy procedure. The diagnosis of tinnitus will include an audiological or medical diagnosis in their health records, as well as a patient affirmation of tinnitus greater than 12 months
5. MML \>= 7 dB (decibel)
6. Have tinnitus score of 40 or greater on the Tinnitus Handicap Questionnaire; (THQ)
7. No tinnitus treatment for at least 4 weeks prior to study entry.
8. Willing and able to understand and comply with all study-related procedures during the course of the study
Exclusion Criteria:
1. Acute or intermittent tinnitus
2. Severe hearing loss in any ear, as defined as more than an 80 dB HL (decibels hearing level) at frequencies from 250 Hz. to 8,000 Hz.
3. Meniere's disease, ear tumors, or evidence of active middle ear disease (such as fluid, infection, tumor, mass)
4. Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug
5. Pregnant or plan on becoming pregnant or breastfeeding during the study period
6. Currently require, or likely to require, MRI or diathermy during the study duration
7. History of adverse reactions to anesthetics (e.g., lidocaine) that in the Investigator's opinion make surgery too risky
8. Beck Depression Inventory (BDI) of 30 or greater
9. Any other form of tinnitus treatments (e.g. Herbal medication, acupuncture or chiropractic medicine) are not allowed during the study.
10. Any drug known to mimic, increase or decrease release or removal of a diffuse neuromodulator, such as norepinephrine, dopamine, serotonin, benzodiazepines, and acetylcholine is not allowed, as well as any psychoactive medications.
11. Significant cardiac history
12. Use of any medication known to cause or increase tinnitus, such as NSAIDS (ibuprofen, naproxen, nabumetone, etc.), aspirin and other salicylates, furosemide (Lasix) and other "loop" diuretics, "mycin" antibiotics such as vancomycin, quinine and related drugs, and chemotherapy agents such as cisplatin.
13. Involvement in litigation (e.g., worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
65 Years
Study:
NCT01962558
Study Brief:
Protocol Section:
NCT01962558