Brain waves were recorded from each participant for 20 minutes before using the PoNS.
NEWTOWN, Pa., Jan. 08, 2018 (GLOBE NEWSWIRE) -- Helius Medical Technologies (TSX:HSM) (TSX:HSM.WT) (OTCQB:HSDT) (“Helius” or the “Company”), a medical technology company focused on neurological wellness, announced today that researchers have completed a study evaluating the investigational Portable Neuromodulation Stimulator (“PoNS”) on brain activity.
The objective of the study, conducted at HealthTech Connex, Inc. in Surrey, British Columbia, was to: 1) evaluate whether a single, twenty-minute session of two PoNS stimulation waveforms - High Frequency (HF) and Low Frequency (LF) - impacted objective measures of brain activity recorded by high density 64-channel electroencephalography (EEG); and 2) whether there were differences between the two PoNS stimulation waveforms. The study randomized a total of 20 healthy neurologically intact participants into two groups to counterbalance exposure order to each PoNS stimulation waveform.
Brain waves were recorded from each participant for 20 minutes before using the PoNS, 20 minutes while using either the HF or LF PoNS device, and then for 20 minutes without the device in the mouth. After a 1 week period, participants repeated the same procedure, this time stimulating with the alternative PoNS device tested in their initial visit. Each subject’s EEG brain activity was then analyzed using Time/Frequency Power Analysis and a Spatial Microstate Analysis.
Highlights of study results:
- EEG results confirmed that Translingual Neurostimulation (TLNS), electrical energy delivered through the PoNS device to the tongue, generated statistically significant differences in brain activity.
- Statistically significant increases in Alpha frequencies of brain waves, which are associated with relaxation and reflection, and Theta frequencies of brain waves, which are associated with idea generation, were observed in the post-stimulation rest period for the HF-first group. The results for the HF-first group suggests an important exposure effect for PoNS stimulation.
- Statistically significant increases in Alpha changes pre-to-post stimulation, which are associated with relaxation and reflection, were present when data for both HF and LF waveform groups were evaluated in combination.
- Significant increases in attention-related brain activity were also seen in the HF group. The effects began during PoNS stimulation and continued to increase following stimulation to a level that was significantly greater than baseline.
“We are delighted with these findings as they confirm several important assumptions about our PoNS technology. Most importantly, the EEG data confirm that even a single PoNS stimulation session has an impact on brain activity,” said Helius’ Chief Medical Officer, Dr. Jonathan Sackier. “The results also provide insights on the differences between PoNS waveforms and potential opportunities for research that will continue to drive improved and more effective technology.”
“We have seen very positive results in our participation as a site for the Helius’ Traumatic Brain Injury trial completed in 2017 with PoNS Therapy and this new work reveals some intriguing observations. When both levels of PoNS stimulation are combined, we see a statistically significant increase in brain activity during the post-stimulus period and the HF pulse seems to have a clearly different exposure effect on brain activity. The implications of seeing these effects is very exciting and as a result, we are pushing ahead with further work in this area and look forward to publishing these data,” said Dr. Ryan D’Arcy, President and Chief Scientific Officer at HealthTech Connex.
About PoNS Therapy
The PoNS is an investigational, non-invasive, medical device designed to deliver neurostimulation through the tongue. Clinical research has shown that electrical stimulation of the tongue activates two major cranial nerves – the trigeminal nerve and the facial nerve. Electrical stimulation of these cranial nerves creates a flow of neural impulses that are then delivered directly into the brain stem and cerebellum. PoNS Therapy combines the use of the PoNS device with physical therapy. The company has completed its clinical trials for balance disorder in patients with mild to moderate Traumatic Brian Injury (TBI) and are looking forward to submitting an application for marketing authorization in the US and other jurisdictions for the PoNS device in the first half of 2018. Additional trials in multiple sclerosis, stroke and cerebral palsy have shown promising results and provide support for pursuing additional indications for use.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a medical technology company focused on neurological wellness. Helius seeks to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. Helius intends to file for FDA clearance for the PoNS device. For more information, please visit www.heliusmedical.com.
About HealthTech Connex.
HealthTech Connex, Inc. is a health technology company working to revolutionize the practice of clinical neuroscience through advanced technologies based on the highest quality science and innovation. Located within the Health and Technology District in Surrey, British Columbia, Canada, HealthTech Connex’s premier focus is on developing advanced brain technologies to objectively monitor brain vital signs. HealthTech Connex launched the Centre for Neurology Studies connecting clinicians, scientists and engineers with advanced R&D and innovative clinical neuroscience breakthroughs to deliver the largest possible societal benefits. www.HealthTechConnex.com
Work pioneered by Dr. Ryan D’Arcy and his team (Ghosh Hajra et al. 2016), has led to the development of a novel approach to extract novel brain vital signs from brainwaves recorded from electroencephalography (EEG). The team isolated well-established brainwave markers for auditory sensation, basic attention, and cognitive processing.
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