This study marks a historic milestone as the first ever
Randomized Controlled Trial (RCT) to demonstrate success in a
non-pharmacological home therapy for Treatment Resistant Major
Depression.
TAMPA, Fla., June 25, 2024 /PRNewswire/ -- Neurolief, a
leading developer of innovative brain neuromodulation technologies,
announces the groundbreaking 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, offering
new hope for millions of patients worldwide who have previously not
responded, or not sufficiently responded, to pharmaceutical
treatments.
The double-blind, randomized, placebo-controlled, multi-center
clinical trial enrolled 124 participants across leading medical
centers in the United States 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.
- Favorable 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% of patients fully complied with the daily treatment regimen
throughout the 16-week treatment period.
Dr. Linda Carpenter,
Professor of Psychiatry and Human Behavior at the Warren Alpert
Medical School at Brown University and
the principal investigator of the trial, stated,
"So many of my patients do not get relief from their
antidepressant medications and struggle to find effective treatment
options for their depression. I want them to get better without
adding more medications to their regimen, but many of them simply
cannot manage daily trips to the clinic for other offered
treatments. I am thrilled that I will soon be able to prescribe
Neurolief's therapy for my patients to treat at home!
The results of this clinical trial not only show this technology
is safe and effective for relieving depression symptoms, but also
that patients can self-administer their therapy in a time and place
when it is convenient for them and get better! This will have a
tremendous impact on the approach for treating major depressive
disorder."
Dr. Mark George,
Distinguished Professor of Psychiatry, Radiology, and Neuroscience
and Director of the Medical University of
South Carolina (MUSC) Brain Stimulation Division, who was an
investigator in the study, commented, "This is such an important
study as it shows that patients with depression can effectively
treat their depression using Neurolief's brain stimulation
technology at home, under a doctor's supervision. This will greatly
expand access to therapy for people who live far away from medical
centers, who are working, have children or cannot travel long
distances to the clinic. This non-medication medical technology has
no drug-drug interactions or other side effects common with
medications. This is a great day for patients with
depression!"
Scott Drees, CEO of Neurolief,
added, "We are dedicated to addressing the unmet needs of patients
and their families affected by the debilitating impacts of
depression. The success of this pivotal trial not only brings us
closer to making this groundbreaking therapy widely available but
also highlights the transformative potential of our technology in
revolutionizing depression treatment."
Neurolief's technology treats major depression by stimulating
the release of neurotransmitters in the brainstem and modulating
brain networks associated with mood regulation. Utilizing 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, analyze their data, and personalize 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, with the goal of securing
approval and moving towards commercialization.
About Major Depressive Disorder (MDD) and Treatment-Resistant
Depression (TRD)
Major depressive disorder (MDD) and treatment resistant
depression (TRD) exert a profound global impact, affecting millions
and significantly contributing to disability, economic burden, and
reduced quality of life. MDD is the leading cause of disability
worldwide, and the challenge is exacerbated in TRD, where patients
fail to respond to standard treatments, leading to prolonged
suffering, higher healthcare costs, and increased risk of comorbid
conditions such as anxiety, substance abuse, and suicide. The lack
of adequately accessible therapies for TRD highlights a critical
gap in mental health care, emphasizing the urgent need for
innovative and effective treatment strategies to alleviate the
global burden of these debilitating disorders and improve patient
outcomes.
About Neurolief
Neurolief is a neuromodulation company dedicated to bringing
relief to patients suffering from mental health and neurological
disorders. The company consists of highly experienced professionals
with a proven track record in neuroscience, neuromodulation
technology, and the neurotech industry. Neurolief has developed a
disruptive platform technology, the world's first and only
non-invasive, multi-channel brain neuromodulation system designed
to concurrently neuromodulate major neural pathways in the head and
thereby affect brain regions involved in the control and modulation
of mood and pain. Neurolief's technology is currently approved by
the FDA and CE for the treatment of migraine, and the company is
presently seeking regulatory approvals for the treatment of
Resistant Major Depression.
Photo -
https://mma.prnewswire.com/media/2446992/Neuroloef_Product_PR_3.jpg
View original
content:https://www.prnewswire.co.uk/news-releases/neurolief-announces-breakthrough-results-from-pivotal-clinical-trial-of-brain-neuromodulation-system-for-treating-major-depressive-disorder-302181937.html