Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

Completed · Not applicable · Has a placebo group

Conditions studied: Tinnitus

In brief

Assess the safety and efficacy of VNS paired with tones for tinnitus using a randomized, controlled, parallel study design.

Key facts

Study ID

NCT01962558

Run by

MicroTransponder Inc.

People needed

30

Starts

2014-02-01

Expected to finish

2016-05-01

Last updated by the study team

2018-04-06

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 22 to 65 years of age
• Have been diagnosed as suffering from sensorineural tinnitus and at least some tonal quality of the tinnitus
• Unilateral or bilateral tinnitus
• 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
• MML >= 7 dB (decibel)
• Have tinnitus score of 40 or greater on the Tinnitus Handicap Questionnaire; (THQ)
• No tinnitus treatment for at least 4 weeks prior to study entry.
• Willing and able to understand and comply with all study-related procedures during the course of the study

You may not qualify if…

• Acute or intermittent tinnitus
• 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.
• Meniere's disease, ear tumors, or evidence of active middle ear disease (such as fluid, infection, tumor, mass)
• Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug
• Pregnant or plan on becoming pregnant or breastfeeding during the study period
• Currently require, or likely to require, MRI or diathermy during the study duration
• History of adverse reactions to anesthetics (e.g., lidocaine) that in the Investigator's opinion make surgery too risky
• Beck Depression Inventory (BDI) of 30 or greater
• Any other form of tinnitus treatments (e.g. Herbal medication, acupuncture or chiropractic medicine) are not allowed during the study.
• 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.
• Significant cardiac history
• 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.
• Involvement in litigation (e.g., worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss).

Where it is running

• U. Iowa — Iowa City, Iowa, United States
• U. Buffalo — Buffalo, New York, United States
• UT Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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