Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03988699|
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Device: Tinnitus Implant System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus: An Early Feasibility Study|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||October 2022|
Experimental: Subject with severe tinnitus
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.
Device: Tinnitus Implant System
Device will deliver stimulation below hearing thresholds continuously or intermittently.
- Number of subjects with treatment-related adverse events [ Time Frame: One year ]Measured by subjects meeting one or more of the following criteria: worsening bone conduction thresholds in any tested frequency (0.25, 0.5, 1, 1.5, 2, 3, or 4 kHz) from baseline by a clinically significant amount (>10 dB) or worsening in WRS from baseline by a clinically significant amount (>20%) or worsening in video head impulse test result from baseline or one or more serious AEs
- Number of subjects to experience significant improvement from implantation of the device [ Time Frame: Baseline, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 52 weeks ]Measured by subjects meeting at least two of three measurements of tinnitus severity: Tinnitus Handicap Inventory (THI) improvement by greater than 7 points using a 25-item self-assessment questionnaire with possible answers of Yes (4 points), Sometimes (2 points), and No (0 points) or Tinnitus Functional Index (TFI) improvement by greater than 13 points using a 25-item self-report questionnaire on a scale of 0 to 10 with a maximum possible score of 250 or Tinnitus visual analog scale improvement by greater than 15 points using a self-reported scale consisting of a 10 cm line with verbal descriptors (word anchors) at each end to express the extremes of the symptom; 0 mm designates no pain and 100 mm designates the greatest imaginable severity of pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988699
|Contact: Nicole M Tombers, RNfirstname.lastname@example.org|
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Matthew L Carlson, MD||Mayo Clinic|