A Blinded Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired with Tones for Tinnitus vs. VNS with Unpaired Tones - MicroTransponder[Single Quote]s Serenity System

Study ID
STU 072013-025

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Zale Lipshy University Hospital

Contact
Parvin Mohazabnia
214/648-6840
PARVIN.MOHAZABNIA@UTSouthwestern.edu

Principal Investigator
Brandon Isaacson, M.D.

Summary

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 (half second tones that occur during brief [1/2]) second bursts of VnS) for 2.5 hours daily (believed effective group) and;
* a group that receives VnS and tones in an unpaired manner for 2.5 hours daily (10 minutes of tones only, 5 minutes of no tones and no VnS, 2 hours of VnS only, 5 minutes of no VnS and no tones, and 10 minutes of tones only).

after device use training, therapy is delivered at home by the patient for 6 weeks. Patients have ten 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 50 patients entered such that 30 can be implanted across four sites is planned for this study.

Participant Eligibility

1. 21 to 65 years of age
2. Have been diagnosed as suffering from sensorineural tinnitus and at least some tonal quality of the tinnitus
3. Unilateral or bilateral tinnitus
4. 4. Have experienced tinnitus for at least one year. The diagnosis of tinnitus will include an audiological or medical diagnosis in their health records, as well as a patient affirmation of tinnitus greater than 12 months
5. MML >= 7 dB
6. Have tinnitus score of 40 or greater on the Tinnitus Handicap Questionnaire; (THQ)
7. No tinnitus treatment for at least 4 weeks prior to study entry.
8. Willing and able to understand and comply with all study-related procedures during the course of the study