NCT01962558

Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: MicroTransponder Inc. · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Tinnitus

Interventions

Type	Name	Description
DEVICE	VNS Treatment	VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.
DEVICE	VNS Control	This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-05-01
• Completion: 2016-05-01
• First posted: 2013-10-14
• Last updated: 2018-04-06
• Results posted: 2018-04-06

Locations

3 sites across 1 country: United States