Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

• ClinicalTrials.gov Identifier: NCT03988699
• Recruitment Status: Active, not recruiting
• First Posted: June 17, 2019
• Last Update Posted: May 3, 2023
• Sponsor: Matthew L. Carlson, M.D.
• Information provided by (Responsible Party): Matthew L. Carlson, M.D., Mayo Clinic

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: N/A
• 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
• Actual Study Start Date: August 23, 2021
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Matthew L. Carlson, M.D.

Investigators

• Principal Investigator: Matthew L Carlson, MD; Mayo Clinic

  Study Documents (Full-Text)

Documents provided by Matthew L. Carlson, M.D., Mayo Clinic:

Informed Consent Form  [PDF] April 21, 2023

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• 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
• Last Update Posted: May 3, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases