Scion NeuroStim announced results from a randomized, controlled trial of Parkinson's disease (PD) subjects who used the Company's non-invasive neuromodulation device TNM have been published in the journal Parkinsonism and Related Disorders.
PD is a progressive neurodegenerative disease associated with a wide range of debilitating symptoms typically separated into motor (movement) and non-motor categories. Finding improved therapies to combat these debilitating symptoms is a primary goal for medical researchers.
The study was conducted by a group led by Dr. David Wilkinson, professor and chair of the School of Psychology at the University of Kent (UK), after earlier positive investigational results with TNM. He conducted the study with the close support of Dr. Mohamed Sakel, Director of the East Kent NHS Neuro-rehabilitation Service and Dr Mayur Bodani, consultant neuropsychiatrist, Kent & Medway NHS and Social Care Partnership Trust, UK. Additional help with participant recruitment was given by the national charity Parkinson’s UK.
The TNM Device is non-invasive and convenient for home use. It directly stimulates the vestibular system, a sensory network that has strong and diffuse pathways throughout the brain.
Subjects diagnosed with PD and receiving stable doses of standard-of-care anti-Parkinsonian therapies were randomized into active and placebo treatment groups. Subjects were evaluated using a comprehensive battery of validated scales and measurements that are used clinically to characterize the different symptoms associated with PD and also to assess the impact of the disease on activities of daily living and quality of life. After a pre-treatment baseline assessment period, each subject used a TNM Device for 2 months and were then re-assessed. They were further evaluated 1 month after and, again, 6 months after treatment-end to investigate potential durable gains.
The results suggest the TNM Device could be used adjunctly to current standard of care PD therapy. Additionally, the broad spectrum of gains observed in this preliminary study suggests a novel mechanism of action that could potentially address multiple motor and non-motor PD symptoms rather than targeting only a single symptom or symptom-type.
Two noted PD experts who were not involved in the study but reviewed the data were Drs. Hubert H. Fernandez and K. Ray Chaudhuri.
Dr. Fernandez, Director, Center for Neurologic Restoration, Neurological Institute at the Cleveland Clinic, noted: “One typically doesn’t see such consistency in study results when evaluating a new therapy. All subjects were being treated with standard medications that increase the levels of dopamine, the natural production of which decreases as PD progresses. The fact that the gains observed were on top of the standard therapies is quite promising.”
Dr. Chaudhuri, the Medical Director of the National Parkinson Foundation International Centre of Excellence at King’s College was impressed by the study data. He notes: “The results are very encouraging. Achieving both widespread efficacy and durable gains in motor and specifically non-motor aspects of PD would be quite novel, and improvements in non-motor symptoms would be especially notable. Those symptoms are often untreated or poorly treated and have a particularly detrimental impact on quality of life, and their treatment is a key unmet need. I am intrigued and want to see where this device technology might go.”
Professor Wilkinson’s research group at the University of Kent, UK, has pioneered the therapeutic application of vestibular stimulation, publishing encouraging results from numerous studies involving individuals with stroke or traumatic brain injury.
The TNM Device 3.2 has been granted market entry in the US (adults and adolescents ages 12 and older) and CE marked in the EU (adults) specifically for prevention of episodic migraine. The TNM Device 4.0 is an FDA-designated Breakthrough Device that is Limited by U.S. Law to Investigational Use and can only be used in the setting of a clinical trial.
Scion NeuroStim, LLC, is a privately held, medical device company dedicated to improving patient outcomes in multiple neurological conditions through non-invasive neuromodulation.
Source: Company Press Release