Relivion DP is a non-invasive and multi-channel brain neuromodulation system for at home treatment of neurological and neuropsychiatric disorders
Neurotechnology company Neurolief has enrolled first patient in the clinical study to assess its brain neuromodulation system, dubbed Relivion DP, to treat major depressive disorder (MDD).
The Relivion DP is claimed to be the first non-invasive and multi-channel brain neuromodulation system for at home treatment of neurological and neuropsychiatric disorders.
In August last year, the company secured breakthrough device designation from the US Food and Drug Administration for Relivion DP device.
The MOOD trial is designed to evaluate the safety and efficacy of Relivion DP as an adjunctive treatment to pharmaceutical management of MDD who have not achieved satisfactory improvement from antidepressant medications.
Neurolief has recruited the first patient at Brown Department of Psychiatry and Human Behaviour in Butler Hospital located in Providence, Rhode Island.
In a statement, the trial principal investigator Dr Linda Carpenter said: “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 latest trial is a prospective, multi-centre, two-arm, double-blind and randomised controlled trial that is followed by an open-label active treatment phase.
The primary endpoint of the trial is said to evaluate changes in depressive symptoms from baseline to eight weeks post-treatment initiation when using Relivion DP, compared to the control group, in subjects suffering from MDD.
Hamilton Rating Scale for Depression will assess the severity of depressive symptoms.
Designed to worn as a headset, Relivion DP will help treat major depression by stimulating the release of neurotransmitters in the brainstem and modulating brain networks linked with mood control.
With the support of three adaptive output channels, the device transfers mild electrical pulses to the brainstem through six branches of the occipital and trigeminal nerves.
These nerves are used as conductors of the electrical stimulation to higher brain regions involved in mood, anxiety and attention disorders.
The Relivion DP device is used in tandem with its dedicated smartphone app and a cloud database to allow physicians to remotely monitor patient, analyse their data, and personalise treatments for better outcomes.
In March this year, Neurolief secured an approval from the FDA for its wearable brain neuromodulation system Relivion to treat migraine.