Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

Tinnitus Clinical Trial

Official title: A Blinded Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus vs. VNS With Unpaired Tones

Status Completed

Clinical Trial Summary

Assess the safety and efficacy of VNS paired with tones for tinnitus using a randomized, controlled, parallel study design.

Clinical Trial Description

Patients who have moderate to severe tinnitus, at least one year post diagnosis, may enroll. All patients will be implanted and randomized to one of two groups:

• a group receiving VNS paired with tones and;

• a group that receives VNS and tones, but with different settings.

After device use training, therapy is delivered at home by the patient for 6 weeks. Patients have eight baseline audiometric assessments along with two questionnaire assessments, an assessment after recovery before treatment starts, and tinnitus assessments every two weeks during therapy through the 6 week randomized portion of the study. After the randomized portion, all patients receive VNS paired with tones. Patients will continue to return for quarterly visits and tinnitus assessments through the first year after implant, regardless of their therapy status. Interested patients can continue to receive longer-term treatment after the first year. A goal of up to 30 patients enrolled and implanted across four sites is planned for this study. ;

Related Conditions & MeSH terms

• Tinnitus

• NCT number: NCT01962558
• Study type: Interventional
• Source: MicroTransponder Inc.
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Completion date: May 2016