INNOVATION TODAY

DESIGNED TO CREATE THE FUTURE

Robust clinical research and pipeline programs are designed to address multiple neurological disorders.

Advancements at Neurolief reach beyond migraine and aim to develop treatment options for patients suffering from many other neurological and neuropsychiatric disorders.

While there is extensive research on the prevalence of conditions such as depression, insomnia, and anxiety and the need for innovative new therapies, current treatments are unsuitable for large parts of the patient population.

MIGRAINE PREVENTION

PERL TRIAL - Coming Soon

Migraine is a common neurological disorder causing recurring moderate to severe headaches with additional symptoms such as photophobia, phonophobia, nausea, and vomiting. Acute therapy aims to stop an attack, while prophylactic treatment aims to prevent them, reduce frequency, severity, and associated disability.

There are various drug therapies used for prevention, but they are rarely curative and often associated with adverse effects.

Neurolief has developed the Relivion MG device for acute migraine and a clinical trial is underway to evaluate its safety and efficacy for migraine prevention. The trial is prospective, non-randomized, single arm, and multi-center.

STUDY HYPOTHESIS AND PRIMARY SCIENTIFIC OBJECTIVE

The Relivion MG daily treatment effectively reduces Monthly Migraine Days (MMD) compared to a pre-specified placebo value.

The study will evaluate the change in MMD from the 28 days prior to treatment initiation to the last 28 days of a 12-week treatment period in individuals with episodic or chronic migraine headache, using Relivion compared to a pre-specified sham performance goal (31, 51).

Depression

The MOOD study - Enrollment Completed

Depression is a mental illness that causes prolonged feelings of sadness, hopelessness, and loss of interest in activities. It can affect daily functioning and physical health. Causes are a mix of genetic, environmental and psychological factors. Treatment options include therapy, medication, and lifestyle changes.

Depression affects millions of people worldwide.*

ARE YOU ONE OF THEM?

The MOOD Study is a prospective, multicenter, two-arm, double-blinded, randomized, controlled trial. MOOD studied the use of the Relivion platform technology in subjects suffering from major depressive disorder.

The target patient population was men and women ages 18-70 years old, who suffer from major depressive disorder.

*According to the World Health Organization, 2020.

The following centers have participated in the study:

Centers

Brain Health Consultants – Houston, Texas

Butler Hospital TMS Clinic Neuromodulation Research Facility – Providence, Rhode Island

Kadima Neuropsychiatry Institute – La Jolla, California

MUSC Institute of Psychiatry – Charleston, South Carolina

K2 Medical Research – Tampa, FL

Northwestern University, Feinberg School of Medicine – Chicago, IL

Providence VA Healthcare System – Providence, Rhode Island

San Marcus Research Clinic – Miami Lakes, Florida

Sheppard Pratt – Baltimore, Maryland

UCLA Semel Institute for Neuroscience and Behaviour – Los Angeles, California

University of Minnesota – Minneapolis, Minnesota

University of North Carolina, Department of Psychiatry – Chapel Hill, North Carolina

Advisory Board – Depression

Andrew Leuchter, MD

Linda Carpenter, MD

Mark George, MD

Yariv Shahak, MD

Future
Innovations

ANXIETY

Anxiety is a normal response to stress, but when it becomes chronic and disrupts daily life, it may be an anxiety disorder. It involves fear, worry, and physical symptoms. Treatment may include therapy, medication, and lifestyle changes.

Anxiety disorders are the most common mental illnesses in the US, affecting 40 million adults in the US age 18 and older, or 18.1% of the population, every year.¹
Anxiety disorders are highly treatable; yet, only 36.9% of those suffering receive treatment.¹
People with an anxiety disorder are three to five times likelier to go to the doctor and six times likelier to be hospitalized for psychiatric disorders than those who don’t have an anxiety disorder.¹

INSOMNIA

Insomnia is a sleep disorder where a person has trouble sleeping. It can be acute or chronic and caused by various factors. Treatment may include identifying underlying causes, improving sleep habits, and using medications or therapy.

REFERENCE

1. Adaa.org. Facts & Statistics. Accessed August 25, 2021. https://adaa.org/understanding-anxiety/facts-statistics

2. Sleep Statistics. Sleepfoundation.org. Published May 2, 2009. Accessed August 25, 2021. https://www.sleepfoundation.org/how-sleep-works/sleep-facts-statistics

3. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211. doi: 10.1177/0333102417738202. PubMed PMID: 29368949.

4. Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21. PubMed PMID: 17261680.

5. Woldeamanuel YW, Cowan RP. Migraine affects 1 in 10 people worldwide featuring recent rise: A systematic review and meta-analysis of community-based studies involving 6 million participants. J Neurol Sci. 2017;372:307-15. doi: 10.1016/j.jns.2016.11.071. PubMed PMID: 28017235.

6. Group GBDNDC. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017;16(11):877-97. doi: 10.1016/S1474-4422(17)30299-5. PubMed PMID: 28931491; PubMed Central PMCID: PMCPMC5641502.

31. Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015;55 Suppl 2:103-22; quiz 23-6. doi: 10.1111/head.12505_2. PubMed PMID: 25662743.

51. Sun-Edelstein C, Rapoport AM. Update on the Pharmacological Treatment of Chronic Migraine. Curr Pain Headache Rep. 2016;20(1):6. doi: 10.1007/s11916-015-0533-9. PubMed PMID: 26728188.