Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus

Tinnitus Clinical Trial

Official title:

Novel Tinnitus Implant System for the Treatment of Chronic Severe Tinnitus: An Early Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03988699
• Other study ID #: 18-007120
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• Tinnitus Implant System
Device will deliver stimulation below hearing thresholds continuously or intermittently.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Matthew L. Carlson, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with treatment-related adverse events	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	One year
Primary	Number of subjects to experience significant improvement from implantation of the device	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.	Baseline, 3 weeks, 5 weeks, 7 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks, 13 weeks, 14 weeks, 15 weeks, 52 weeks