Two Separate NIH-Funded Studies Needs Subjects with Tinnitus and Hearing Loss
Michael Seidman, M.D., Henry Ford Hospital and HLAA medical advisor is seeking people for two separate National Institutes of Health-funded studies on tinnitus:
- Vagal Nerve Study seeks people who have tinnitus with sensorineural hearing loss.
- AM 101 Study seeks people who have been diagnosed within the past three months or less with acute inner ear tinnitus brought on by acoustic trauma, barotrauma, operation on the middle ear, traumatic perforation of the eardrum or middle ear infection.
Read more about the details of both studies and participant qualifications below.
VAGAL NERVE STUDY DETAILS
Henry Ford Health System, in collaboration with Wayne State University (WSU), 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 600 million people worldwide.
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.
Michael Seidman, M.D., at Henry Ford and Anthony Cacace, Ph.D., at WSU are 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.
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.
We are 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.
AM 101 STUDY DETAILS
DETROIT and NOVI – Henry Ford Health System and Michigan Ear Institute have launched a clinical trial to investigate a new drug for the treatment of tinnitus, a chronic ringing of the head or ears that affects more than 600 million people worldwide.
The study will examine AM-101, a gel injected into the middle ear, to determine its safety and effectiveness in lessening the excessive signaling to the brain that occurs with acute inner ear tinnitus, most often caused by noise trauma or infection.
AM-101 inhibits certain receptors in the inner ear that are thought to play a key role in the development of tinnitus. This inhibitory effect has been investigated and confirmed in animal behavior models.
Henry Ford and MEI are two of 70 sites worldwide involved in this National Institutes of Health-supported study and it is currently recruiting patients.
“More recent theories assume that, while it starts in the ear, tinnitus becomes ‘centralized’ in the brain over time, where it can persist even if the original damage is no longer present in the inner ear,” 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.
“Since the chances of a cure for this type of permanent tinnitus are very low, attempts are being made to treat the tinnitus at an early stage, focusing on the inner ear.”
Notably, tinnitus affects more than 12 percent of American troops who have been exposed to acoustic trauma from machinery and explosive devices. It is now the number one disability among women and men in uniform and our government will spend close to $ 2 billion dollars annually to help our troops with this problem.
Tinnitus in the inner ear is often a consequence of an acoustic trauma, barotrauma, operation on the middle ear, traumatic perforation of the eardrum or middle ear infection. While the tinnitus often goes away after a short period in these circumstances, it can persist in some cases even after the injury has healed.
For its study, we need to recruit patients who have experienced tinnitus for three months or fewer following traumatic cochlear injury or otitis media, an inflammation of the middle ear.
In an outpatient procedure, the study drug AM-101 or a placebo will be injected into the middle ear, where it then passes into the inner ear, following the administration of a local anesthetic to the eardrum. The injection will be repeated two more times during a five-day period.
Patients in the study also will need to return for several follow-up visits.
Throughout the study, patients will be asked each evening to answer two short questions on the loudness of the tinnitus and the associated annoyance in an electronic diary.
In order to investigate the efficacy of AM-101, it must be possible to compare the improvement in the tinnitus after the injection with a control group. Therefore, some of the participants will receive a placebo preparation. Neither the patient nor the study doctor will know who has received AM-101 or the placebo. After the initial study is complete ALL program participants will have the opportunity to receive the study drug (i.e., if you were given the placebo, you will be able to receive the actual drug)
Michael D. Seidman. M.D., and Eleanor Y. Chan, M.D. (MEI) are seeking patients, ages 18-75, who have been diagnosed within the past three months or less with acute inner ear tinnitus brought on by acoustic trauma, barotrauma, operation on the middle ear, traumatic perforation of the eardrum or middle ear infection.
Those whose tinnitus has existed for more than three months, or was triggered by events other than traumatic cochlear injury or middle ear infection, may not take part in the study.
Participants must agree to use hearing protection, refrain from engaging in activities or work involving loud noise exposure if sufficient hearing protection is not possible, and able to protect ear canal and middle ear from water exposure, 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:
- Pregnant or breastfeeding
- Fluctuating or intermittent tinnitus
- Tinnitus from traumatic head or neck injury
- Suspected of diagnosed Meniere’s disease; history of endolymphatic hydrops, or history of fluctuating hearing loss
- History of repeated idiopathic sudden sensorineural hearing loss
- Ongoing, infection of otitis media or otitis externa
- Abnormality of the tympanic membrane in the affected ear(s)
- Hearing loss in the affected ear(s) of 75 dB or more
- Fluctuating hearing
- Any drug-based therapy for otitis media or otitis externa that is ongoing or was performed in the past two weeks
- Any drug-based therapy known as potentially tinnitus-inducing
- Use of any other NMDA receptor antagonist (e.g. memantine, dextromethorphan) in the past two weeks or that is ongoing
- History within the past two years or presence of drug abuse or alcoholism
- Diagnosed as having anxiety disorders, depression, bipolar disorders, schizophrenia or other psychiatric diseases requiring current drug treatment or subjects who required treatment in the previous three months
- Use of any antidepressant or anti-anxiety medication in the past two weeks or that is ongoing
- Any clinically relevant respiratory, cardiovascular, neurological disorder (except vertigo), as determined by the Investigator
- Known hypersensitivity, allergy or intolerance to the study medication o any history of severe drug reaction
For more information about the study, prospective participants should call Dr. Seidman at 248.661.7211 or visit www.tinnitustrial.com.
Michael D. Seidman, MD., FACS
Henry Ford Health System
Director Division Otologic/Neurotologic Surgery
Medical Director Center for Integrative Medicine
Medical Director Wellness Henry Ford Hospital
Clinical Professor of Otolaryngology Wayne State University School of Medicine
Past Chair Board of Governors American Academy of Otolaryngology-Head and Neck Surgery
Board of Directors, American Academy of Otolaryngology-HNS
Director at Large AAO-HNS