Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

Not Applicable

Active, not recruiting

• Conditions: Tinnitus

• Registration Number: NCT03988699
• Lead Sponsor: Matthew L. Carlson, M.D.

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.

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 Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-14
• Study First Posted: 2019-06-17
• Study Start: 2021-08-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of subjects with treatment-related adverse events	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	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States