Journal article
Vagus Nerve Stimulation Paired with Tones for the Treatment of Tinnitus: A Prospective Randomized Double-blind Controlled Pilot Study in Humans
Scientific reports, Vol.7(1), 11960
09/20/2017
DOI: 10.1038/s41598-017-12178-w
PMCID: PMC5607328
PMID: 28931943
Abstract
The aim of the pilot study was to evaluate the effect of Vagus Nerve Stimulation (VNS) paired with sounds in chronic tinnitus patients. All participants were implanted and randomized to a paired VNS (n = 16) or control (n = 14) group. After 6 weeks of home therapy, all participants received paired VNS. The device was used on 96% of days with good compliance. After 6 weeks, the paired VNS group improved on the Tinnitus Handicap Inventory (THI) (p = 0.0012) compared to controls (p = 0.1561). The between-group difference was 10.3% (p = 0.3393). Fifty percent of the participants in the paired VNS group showed clinically meaningful improvements compared to 28% in controls. At one year, 50% of participants had a clinically meaningful response. The therapy had greater benefits for participants with tonal and non-blast induced tinnitus at the end of 6 (24.3% vs. 2%, p = 0.05) and 12 weeks (34% vs. 2%, p = 0.004) compared to controls with 80% and 70% responding at 6 months and 1 year, respectively. Adverse effects were mild and well-tolerated and the therapy had a similar safety profile to VNS for epilepsy. VNS paired with tones may be effective for a subgroup of tinnitus patients and provides impetus for a larger pivotal study.
Details
- Title: Subtitle
- Vagus Nerve Stimulation Paired with Tones for the Treatment of Tinnitus: A Prospective Randomized Double-blind Controlled Pilot Study in Humans
- Creators
- Richard Tyler - University of Iowa Department of Otolaryngology-Head and Neck Surgery and Communication Sciences and Disorders, The University of Iowa, Iowa City, IA, USA. rich-tyler@uiowa.eduAnthony Cacace - Department of Communication Sciences & Disorders, Wayne State University, Detroit, MI, USAChristina Stocking - Department of Communicative Disorders and Sciences, University at Buffalo, Buffalo, NY, USABrent Tarver - MicroTransponder, Inc., 2802 Flintrock Trace, Suite 226, Austin, TX, USANavzer Engineer - MicroTransponder, Inc., 2802 Flintrock Trace, Suite 226, Austin, TX, USAJeffrey Martin - Callier Center for Communication Disorders, School for Behavioral and Brain Sciences, University of Texas at Dallas, Richardson, TX, USAAniruddha Deshpande - Department of Speech-Language-Hearing Sciences, Hofstra University, Hempstead, NY, USANancy Stecker - Department of Communicative Disorders and Sciences, University at Buffalo, Buffalo, NY, USAMelissa Pereira - Department of Communicative Disorders and Sciences, University at Buffalo, Buffalo, NY, USAMichael Kilgard - Texas Biomedical Device Center, University of Texas at Dallas, Richardson, TX, USAChester Burress - MicroTransponder, Inc., 2802 Flintrock Trace, Suite 226, Austin, TX, USADavid Pierce - MicroTransponder, Inc., 2802 Flintrock Trace, Suite 226, Austin, TX, USARobert Rennaker - Texas Biomedical Device Center, University of Texas at Dallas, Richardson, TX, USASven Vanneste - Lab for Clinical and Integrative Neuroscience, School for Behavioral and Brain Sciences, University of Texas at Dallas, Richardson, TX, USA
- Resource Type
- Journal article
- Publication Details
- Scientific reports, Vol.7(1), 11960
- DOI
- 10.1038/s41598-017-12178-w
- PMID
- 28931943
- PMCID
- PMC5607328
- NLM abbreviation
- Sci Rep
- ISSN
- 2045-2322
- eISSN
- 2045-2322
- Publisher
- England
- Grant note
- U44 DC010084 / NIDCD NIH HHS
- Language
- English
- Date published
- 09/20/2017
- Academic Unit
- Communication Sciences and Disorders; Otolaryngology
- Record Identifier
- 9984002321302771
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