Henry Ford Seeks Tinnitus Patients for Vagal Nerve Stimulation Clinical Trial
Released: 6/24/2014 2:00 PM EDT
Source Newsroom: Henry Ford Health System
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Newswise — DETROIT – Henry Ford Health System, in collaboration with Wayne State University, is one of four sites worldwide involved in a clinical trial that will test a device that uses nervous system stimuli to rewire parts of the brain, in hopes of significantly reducing or removing tinnitus, a chronic ringing of the head or ears that affects more than 50 million people.
The National Institutes of Health-supported study will examine the effectiveness and safety of the vagal nerve stimulator (VNS) – a small, surgically implanted device that uses electrical impulses to stimulate the vagus nerve – to treat tinnitus.
Henry Ford is currently recruiting patients who have experienced tinnitus for at least one year to take part in the blinded, two-arm study for approximately 10-weeks, with long-term follow-up for those who continue to receive therapy.
“There is still no known cure for tinnitus, so we’re continuously working to find new treatment options that are safe, effective and help improve the quality of life for patients with tinnitus,” says study lead investigator Michael D. Seidman, M.D., director of the Division of Otologic/Neurotologic Surgery in the Department of Otolaryngology-Head & Neck Surgery at Henry Ford.
Several conditions have been shown to trigger or worsen tinnitus: Exposure to loud noises, hearing loss, tumors of the hearing/balance nerve, wax build-up in the ear, ear or sinus infections, head and neck trauma, and certain disorders such as hypo- or hyperthyroidism, Lyme disease, fibromyalgia and thoracic outlet syndrome.
While the exact physiological cause of tinnitus is not known, previous research suggests tinnitus might be the “result of the brain trying to regain the ability to hear those lost frequencies by turning up the signals of neurons in neighboring frequencies.” Those changing brain patterns may be to blame for the phantom sounds of tinnitus.
Similar to a pacemaker for the heart, the VNS uses electrical impulses to send signals along the vagus nerve to the brainstem, taking advantage of the ability of the brain’s neurons to reconfigure their connections and behavior (neuroplasticity).
The device is surgically implanted under the skin on the chest. A wire is then threaded under the skin to connect the device to the vagus nerve, a large nerve that extends from the head and neck to the abdomen and commands voice (vocal cord movement) and involuntary body movements like as heart rate and food digestion.
Once the device is active, patients will undergo combined audio therapy. During therapy, patients wear headphones and listen to a series of single frequency tones, paired with stimulation, to encouraging neurons in the brain to change their connections and behavior. The 2.5-hour session will take place five days a week during the course of 4 weeks, initially in clinic and then at home.
To test the effectiveness of VNS to treat tinnitus, patients in the study will be randomly selected to take part in one of two groups:
• One group will get the VNS and tone test treatment immediately
• The other group will get the VNS, but “sham” therapy that is not expected to have a therapeutic benefit
After six weeks, both groups will receive active test treatment.
VNS is currently approved by the U.S. Food and Drug Administration for use in the treatment of epilepsy and depression. More than 60,000 devices have been implanted in patients with epilepsy during the past 15 years.
Study participants
The Henry Ford study is seeking patients, ages 22-65, who have been diagnosed with subjective tinnitus due to hearing loss with sensorineural aspects and at least some tonal quality of the tinnitus. Participants must have experienced tinnitus (unilateral or bilateral) for at least one year.
Those selected for the study must agree to no tinnitus treatment for at least four weeks prior to entering the study, as well as be willing to comply with all study-related procedures during the course of the clinical trial.
Patients do NOT qualify for the study if they have/are:
• Acute or intermittent tinnitus
• Severe hearing loss (defined as more than an 80 dB HL)
• 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, plan to become pregnant or breastfeeding during the study
• Medications that influence neuromodulators
• Significant cardiac medical history
• Taking meds known to worsen tinnitus
• Taking meds that impact neuromodulation
For more information about the study, visit www.tinnitustrial.com. To enroll, prospective participants should call (248) 661-7211.
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