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Tinnitus Implant for Tinnitus
N/A
Waitlist Available
Led By Matthew L Carlson, MD
Research Sponsored by Matthew L. Carlson, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Summary
This trial is testing a new device called the Tinnitus Implant System for people with persistent ringing in their ears. The device is surgically implanted and helps reduce the ringing sound. Participants will need to visit the clinic periodically for adjustments and evaluations.
Who is the study for?
Adults over 18 with severe, persistent tinnitus not helped by usual treatments like hearing aids. They should have had tinnitus for at least 6 months but no more than 3 years, and have a certain level of hearing loss and speech recognition ability.
What is being tested?
The trial is testing the Tinnitus Implant System to see if it's safe and works for treating chronic severe tinnitus. Participants will receive this novel device designed specifically for those who haven't found relief through conventional methods.
What are the potential side effects?
Potential side effects are not detailed in the provided information. However, as with any implant procedure or device, there could be risks such as infection, discomfort at the implant site, or worsening of symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of subjects to experience significant improvement from implantation of the device
Number of subjects with treatment-related adverse events
Trial Design
1Treatment groups
Experimental Treatment
Group I: Subject with severe tinnitusExperimental Treatment1 Intervention
Subjects diagnosed with severe tinnitus for at least six months, and it has not responded to conventional management will have surgical implantation of the device Tinnitus Implant System.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for tinnitus, such as transcranial magnetic stimulation (TMS) and transcutaneous electrical nerve stimulation (TENS), work by modulating neural activity in the auditory pathways. These techniques use magnetic fields or electrical currents to alter brain activity, aiming to disrupt the abnormal neural signals that cause tinnitus.
This approach is significant for patients because it targets the root cause of tinnitus symptoms, offering a potential pathway to relief by addressing the underlying neural dysfunction.
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Who is running the clinical trial?
Matthew L. Carlson, M.D.Lead Sponsor
Matthew L Carlson, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
67 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You experience tinnitus in only one ear or the sound is louder in one ear compared to the other.You have a normal CT scan of your temporal bone.You must be 18 years old or older.Your score on the PHQ-8 test is higher than 9, which means you may have significant depression.You have a high level of anxiety about being sick.You are currently taking medications for depression, anxiety, or mental illness.You are currently using other treatments for tinnitus, except for non-masking hearing aids.You are unable to participate in, stay in, or finish the trial.You have had tinnitus for less than 6 months or longer than 3 years.You are currently pregnant.Your score on the GAD-7 anxiety test is higher than 9, which means you have significant anxiety.Your head MRI shows no unusual changes when a special dye is used.Your hearing loss is not severe (less than or equal to 70 decibels) and you can understand speech well (word recognition score of at least 75%).You have had tinnitus for at least 6 months but not longer than 3 years.You have had a serious head injury in the past.You have significant symptoms of depression or anxiety based on specific screening tests.You have bothersome tinnitus.Your THI score is very high, at least 56 out of 100.Your TFI score is very high, 52 out of 100 or more.You have severe tinnitus, rated at 50 out of 100 or higher.You have constant ringing in your ears that hasn't improved with regular treatments like a hearing aid or sound masking.
Research Study Groups:
This trial has the following groups:- Group 1: Subject with severe tinnitus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Tinnitus Patient Testimony for trial: Trial Name: NCT03988699 — N/A
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