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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 : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew L. Carlson, M.D., Mayo Clinic

Brief Summary:
Researchers are gathering information on the safety and effectiveness of a novel device called the Tinnitus Implant System for the treatment of tinnitus.

Condition or disease Intervention/treatment Phase
Tinnitus Device: Tinnitus Implant System Not Applicable

Detailed Description:
This study requires one year of participation with at least 21 visits to Mayo Clinic in Rochester MN for device programming and audiometric testing. The device is implanted during an outpatient surgery. Participants may keep the study device after participation is complete.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus: An Early Feasibility Study
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age: ≥18 years of age
  • Normal to moderate SNHL (≤70 dB HL; based on PTA of 0.5, 1 and 2 kHz) and WRS ≥ 75%.
  • Unilateral or asymmetrical subjective tonal tinnitus
  • Tinnitus present for at least 6 months, but not longer than 3 years
  • Tinnitus that is disruptive

    • THI score in the severe range (≥56/100)
    • TFI score in the severe range (≥52/100)
    • Tinnitus VAS ≥50/100
  • Tinnitus that is intractable, and has not been ameliorated by conventional measures such as a hearing aid or masking

Exclusion Criteria

  • Age: <18 years of age
  • Tinnitus present less than 6 months or longer than 3 years
  • Current pregnancy
  • History of brain or major ear surgery
  • Prior major head trauma

    • Presence of clinically significant depressive or anxiety symptoms determined by screening using the GAD-7, PHQ-8, and SHAI

      • GAD-7 >9 (indicates clinically significant anxiety)
      • PHQ-8 >9 (indicates clinically significant depression)
      • SHAI >25 (hypochondriacal level illness anxiety)
    • Inability to assess, continue or complete trial
  • Currently on antidepressants, anxiolytics or antipsychotics
  • Active use of other tinnitus treatments (not including non-masking hearing aid use)
  • Normal contrast-enhanced MRI of the head
  • Normal temporal bone CT

Information from the National Library of Medicine

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


Contacts
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Contact: Nicole M Tombers, RN 507-284-8532 tombers.nicole@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Matthew L. Carlson, M.D.
Investigators
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Principal Investigator: Matthew L Carlson, MD Mayo Clinic

Additional Information:
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Responsible Party: Matthew L. Carlson, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03988699    
Other Study ID Numbers: 18-007120
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms