Phase I trial of caudate deep brain stimulation for treatment-resistant tinnitus.

ABSTRACT:

Objective

The objective of this open-label, nonrandomized trial was to evaluate the efficacy and safety of bilateral caudate nucleus deep brain stimulation (DBS) for treatment-resistant tinnitus.

Methods

Six participants underwent DBS electrode implantation. One participant was removed from the study for suicidality unrelated to brain stimulation. Participants underwent a stimulation optimization period that ranged from 5 to 13 months, during which the most promising stimulation parameters for tinnitus reduction for each individual were determined. These individual optimal stimulation parameters were then used during 24 weeks of continuous caudate stimulation to reach the endpoint. The primary outcome for efficacy was the Tinnitus Functional Index (TFI), and executive functi

SUBMITTER: Cheung SW 

PROVIDER: S-EPMC7089839 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature