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Vagus Nerve Stimulation Paired with Tones for the Treatment of Tinnitus: A Prospective Randomized Double-blind Controlled Pilot Study in Humans.


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.

SUBMITTER: Tyler R 

PROVIDER: S-EPMC5607328 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Vagus Nerve Stimulation Paired with Tones for the Treatment of Tinnitus: A Prospective Randomized Double-blind Controlled Pilot Study in Humans.

Tyler Richard R   Cacace Anthony A   Stocking Christina C   Tarver Brent B   Engineer Navzer N   Martin Jeffrey J   Deshpande Aniruddha A   Stecker Nancy N   Pereira Melissa M   Kilgard Michael M   Burress Chester C   Pierce David D   Rennaker Robert R   Vanneste Sven S  

Scientific reports 20170920 1


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 b  ...[more]

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