LivaNova and Verily are have enrolled the first patient in a sub-study that will use wearables to assess measures for depressive measures.
UNCOVER is an opt-in research study for patients taking part in the ongoing London-based LivaNova’s clinical study RECOVER , “A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy as Adjunctive Therapy Versus a No Stimulation Control in Subjects with Treatment-Resistant Depression.”
The UNCOVER sub-study deploys technology-enabled research tools from Verily to evaluate the real-world effectiveness of VNS Therapy as an adjunctive treatment for difficult-to-treat depression (DTD).
LivaNova and Verily first announced UNCOVER in February of 2020.
Participants in the UNCOVER sub-study will use two Verily-developed digital tools – a wearable, multi-sensor device Verily Study Watch along with an Android smartphone application (Verily Mood App). The Verily tools measure passive and active data, such as the participant’s pulse rate, activity levels and sleep quality. The Mood App also allows participants to record voice diaries to more accurately assess depressive episodes and their effect on daily living.
“These Verily tools will collect behavioral, environmental, and physiological data from study participants, with the goal of painting a clearer picture of depressive episodes and the impact depression has on individual’s lives over the course of the study,” Dr. William Marks, Head of Clinical Science and Neurology at Verily, said in a release.
Neuromodulation has once again become one of the key pillars of LivaNova’s focus. The company made sweeping changes last year and announced it was selling its heart valve business to Gyrus Capital.
It could be argued the divestiture and sweeping changes were a result of an October 2020 letter from activist investor PrimeStone Capital urging LivaNova to focus on its neuromodulation.