At the initial visit, you will review the consent document for this study. You will be given the opportunity to ask as many questions as you would like. You can take the consent form home to think about the study and return at a later date to enroll if you would like time to consider participating. Once you sign the consent, we will ask you to complete some questionnaires (THQ, BDI) and we will do some audiology tests (Audiogram, MML) to see if you can continue in the study. If you are eligible to continue, the following will occur:
We will collect baseline measures for at least an additional seven measurements within a four-week period. Tinnitus questionnaires will be performed twice during baseline (on enrollment and one other time prior to implant), at V3 (after 6 weeks of therapy), V6 (after 12 weeks of therapy), and at each long-term visit. Audiology (MML, loudness, etc.) will be performed 8 times prior to implant and at each visit after implant;
Device implant surgery will occur within two weeks of the last assessment test. After implant surgery and recovery, you will be randomized into a study group, and then study treatment will begin. You will be randomly placed into one of the setting groups: this means you have an equal chance of being placed in either group, like the chance of heads or tails with a flipped coin. You will either receive treatment or sham treatment daily for 6 weeks.
You will then enter the long-term follow-up after 6 weeks of blinded, controlled therapy. All subjects will be on treatment settings (VNS + tones) during this portion (although long-term settings may be modified as described below); you will then be seen every two weeks for another 6 weeks, quarterly for the next 9 months (balance of the first year after implant) and yearly thereafter.
During long-term follow-up, you will return every three months for the next year and then yearly for as long as you continue to receive therapy until commercial approval (FDA PMA approval) is received.
If you are interested to be involved in this study you press "continue"
Callier Center for Communication Disorders, School of Behavioral and Brain Sciences, University of Texas at Dallas
Department of Otolaryngology-Head and Neck Surgery at UT Southwestern Medical Center