Israeli neurotechnology firm Neurolief has enrolled the first participant in the clinical study of its brain neuromodulation system for treating major depressive disorder (MDD).
Named Relivion DP, the non-invasive, multi-channel brain neuromodulation system is intended to treat neurological and neuropsychiatric conditions at home.
It is designed to simultaneously neuromodulate key neural pathways in the head, in turn impacting brain regions associated with mood as well as pain control and regulation.
To be worn as a headset, the Neurolief system induces the release of neurotransmitters in the brainstem and modulates brain networks related to mood control to treat major depression.
Relivion DP uses three adaptive output channels to send mild electrical pulses to the brainstem.
The new prospective, multi-centre, two-arm clinical study, referred to as MOOD, will evaluate the safety and efficacy of the system as an adjunctive to pharmaceutical management of MDD.
MOOD will involve adults who have had inadequate improvement with antidepressant drugs.
The first participant was recruited at Butler Hospital, Brown Department of Psychiatry and Human Behavior, Providence, Rhode Island, US.
MOOD principal investigator Linda Carpenter said: “With treatment-resistant depression, many people struggle to find the medication that works for them, while others never respond to standard treatments.
“The Relivion DP device offers a promising and convenient non-pharmacological solution with the potential to address the unmet needs of patients who do not respond to traditional therapies.”
The double-blind, randomised controlled part of the study will precede an open-label active treatment part.
Changes in depressive symptoms from baseline to eight weeks after starting treatment with Relivion DP versus the control group is the study’s primary endpoint.
The depressive symptoms severity will be analysed using the Hamilton Rating Scale for Depression.
Relivion DP is meant to be utilised with an associated smartphone app and a Cloud database. This enables remote monitoring of patients, assessment of their data and customisation of treatments to improve outcomes.
The system received breakthrough device designation from the US Food and Drug Administration in August 2020.