UK-based medical device manufacturer LivaNova and Verily, a subsidiary of Alphabet, have enrolled the first patient in their collaborative study UNCOVER.
UNCOVER is an opt-in research study for patients in the company’s ongoing RECOVER study, which evaluates Vagus Nerve Stimulation (VNS) therapy in people with treatment-resistant depression.
The 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’s VNS Therapy system Symmetry has received CE Mark approval for DTD, in March 2020, and has received US Food and Drug Administration (FDA) approval in September 2019.
LivaNova CEO Damien McDonald said: “For as many as one in three patients, medication alone may not be enough to combat depression that is difficult to treat.
“As we re-confirm the effectiveness of VNS therapy in treating depression through the RECOVER study, we hope to learn even more through the UNCOVER sub-study about each patient’s journey and the daily improvements in their lives with the use of Verily tools so we can provide the most effective treatment for this disorder.”
UNCOVER sub-study will use two Verily-developed digital tools, including a wearable, multi-sensor device and an Android smartphone application called Verily Mood App.
The Verily tools are designed to measure passive and active data, including 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.
The data obtained from these Verily tools will supplement the clinical outcomes collected in the RECOVER study, offering a comprehensive view of a patient’s depression level.
Verily clinical science and neurology head William Marks said: “After detailed planning with our colleagues at LivaNova, we are pleased to have launched the UNCOVER study and enrolled the first participant.
“These Verily tools will collect behavioural, 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.”
