Neurolief, a developer of innovative brain neuromodulation technologies, announces the topline results from its pivotal clinical trial evaluating the efficacy and safety of its revolutionary brain neuromodulation therapy for patients suffering from Treatment Resistant Depression (TRD). Neurolief’s non-invasive medical technology, designed for clinic and at-home treatment, marks a significant advancement in the management of TRD.
The double-blind, randomised, placebo-controlled, multi-centre clinical trial enrolled 124 participants across leading medical centres in the US and Israel. The study’s primary endpoint was a reduction in depression severity as measured by the Hamilton Depression Rating Scale (HDRS17). Key findings from the trial include:
- Significant reduction in depression symptoms: Patients receiving Neurolief’s brain neuromodulation therapy showed a statistically significant reduction in HDRS17 scores compared to the control group.
- High remission rate: A substantial proportion of patients achieved full remission from depression symptoms (HDRS17 score ≤7), demonstrating the therapy’s profound impact.
- Favourable safety profile: The therapy was well-tolerated, with no serious adverse events related to the treatment, underscoring its safety.
- High adherence to the treatment protocol: Approximately 95 per cent of patients fully complied with the daily treatment regimen throughout the 16-week treatment period.
Neurolief’s technology treats major depression by stimulating the release of neurotransmitters in the brainstem and modulating brain networks associated with mood regulation. Utilising three adaptive output channels, the device non-invasively transfers electrical pulses to the brainstem via major neural pathways in the head. These pathways conduct the electrical stimulation to the brainstem and higher brain regions involved in depression. Designed for at-home treatment, the system incorporates a patient mobile app and a physician interface with cloud-enabled data-tracking features and AI integration. This setup allows physicians to monitor patients, analyse their data, and personalise treatment, thereby enhancing therapy outcomes.
Neurolief previously received Breakthrough Device designation from the FDA for its technology targeting Major Depression. The company plans to submit the pivotal trial results to regulatory authorities in the coming months, to secure approval and move towards commercialisation.