'THIS IS EXCITING AND MOST IMPORTANTLY, IT’S HAPPENING'

TECHNOLOGY

This is completely new and innovative technology, with a design that Steve Jobs would be proud of

In the growth of the neurostimulation market globally, Helius Medical Technologies is playing an increasingly central role, with its PoNS device changing the lives of MS patients in North America and helping to demonstrate the impact of non-invasive technology in neurological disorders. NR Times speaks to Helius’ CEO Dane Andreeff about its pioneering work

Through stimulation of the tongue, people living with Multiple Sclerosis (MS) are being supported to overcome symptoms and rediscover valuable aspects of their life. Groundbreaking technology developed by Helius Medical Technologies - the Portable Neuromodulation Stimulator (PoNS™) - is changing the reality for so many people with MS by helping them to vastly improve their balance and gait dysfunction. In people with mild to moderate MS, the PoNS has been proven in clinical studies and trials to be highly effective, with one vocal advocate of the technology being legendary US television Montel Williams, who lives with relapsing remitting MS and helped to co-found Helius in 2013, credits the PoNS with changing his life. Designed for use over a 14-week period for 20 minutes twice a day, initially under supervision in a specialist clinic but then can be used at home, the 143 gold-plated sensors on the tongue plate stimulate two major cranial nerves in the brain to help amplify its ability to heal itself. The translingual neurostimulation (TLNS) technique creates a flow of neural impulses which are delivered directly to the brain stem, which can then travel through the brain and activate or re-activate neurons and structures. The PoNS system, which is already commercially available in Canada, is now set to launch for MS patients in the US in Q1 of 2022 and is helping to lead fast-developing global efforts to devise and develop non-invasive and non-implantable neurostimulation techniques which can significantly benefit the lives and futures of patients. And while its operation currently is in addressing MS gait and balance issues, Helius is actively looking to widen its application into stroke and TBI, helping people with such

TECHNOLOGY

conditions to recover lost function and improve their quality of life. The business has recently secured its second Breakthrough Designation from the FDA in dynamic balance and gait deficit due to symptoms from stroke, recommending its use in patients aged 22 and over as part of a supervised therapeutic exercise programme - hailed as an “Important milestone” in its journey to changing lives of people living in the US. “This is completely new and innovative technology, with a design that Steve Jobs would be proud of,” says Dane Andreeff, who first became involved with Helius as an investor and took over as CEO last August, leading the rapid development of the revitalised business and raising new capital to drive its expansion forward. “Our clinical data in MS shows that PoNS gives two times the benefit of physical therapy alone. We have seen some stunning improvements in their gait - we have seen movement of eight points on the Dynamic Gait Index, where a movement of four points is considered significant. “We have a very large and proactive audience of MS patients, who live with a very uncomfortable chronic illness, and this helps to meet their unmet needs in gait deficit. It’s amazingly innovative and doesn’t require the two or three-hour surgery for an implantable device. “We are ready to move into the US in the first quarter of 2022 and have a fantastic MS advisory board to support us. “This is exciting and most importantly, it’s happening. We have clinical data and real-world evidence on TBI and stroke, too. I have a big heart and for too long I have seen patients living with these conditions and I think ‘I wish I could help you’. Hopefully that can be the next step for us in our advancement of the technology.” Helius’ pioneering application of neuroplasticity to rehabilitation is the brainchild of scientists at the University of Wisconsin-Madison Tactile Communication and Neurorehabilitation Laboratory (TCNL), building on decades of previous research into the field of neuromodulation. The company went on to be granted Breakthrough Device Designation in MS, becoming one of only 5.6 per cent of businesses given this status to then secure FDA clearance. With the impact of the PoNS continuing to be proven, both through clinical data and real world experience, cofounder Montel Williams is still the longest-serving user of the device following his MS diagnosis in 1999, living with its effects for over ten years before the discovery of the device which would change his life. “You wouldn’t even know he has MS now from his balance or gait. But before PoNS, he was misdiagnosed four or five times and at times couldn’t even walk, you’d have to hold him up. Now he’s skiing and snowboarding and in terrific shape,” says Dane. “I saw him recently and he continues to beat it, he’s an amazing human being and he shows how life-changing the effect can be. We can see through examples like this, as well as through our clinical data, the improvement the PoNS can help deliver, and we hear of improvement with depression, anxiety and quality of life issues too, although we don’t have any clinical claims on that.” Going forward, expansion into the EU is on the agenda following Helius’ successful launch in the US, with brain injury and stroke patients also set to be supported by PoNS. “What we do is critical to quality of life, to helping people improve their gait, and it really excites us,” says Dane. “This is a whole new industry, it’s completely innovative, and we can’t wait to be able to help more people living with MS, and eventually those living with stroke and TBI, across North America.”

THERAPY

Blues & Tunes music therapy pilot programme a success

Blue Light Symphony Orchestra (BLSO) in partnership with Chroma, successfully delivered a feasibility project investigating whether the use of Music Therapy (MT) could be used as a treatment modality, to emergency service workers who were exhibiting PTSD-like symptoms.

BLSO aims to improve the mental wellbeing of emergency service workers through music. They were granted £10,000 lottery funding which was used to help fund this pilot. Over 12 weeks, emergency service personnel took part in the trial MT programme after they were assessed as having PTSD-like symptoms. Further in-take assessments via the GAD and the PHQ9 were also undertaken through the project. Amanda Thorpe, HCPC Music Therapist and NMT Fellow delivered the sessions on behalf of Chroma, the UKs leading arts therapy provider. Each session followed a similar structure designed to allow participants to experience, reflect, learn, and transfer strategies into everyday life. Psychodynamic music therapy, Neurologic Music Therapy (NMT) and Dialectical Behaviour techniques were implemented. The group incorporated free improvisation, the learning of some simple drumming techniques, blended with health and wellness education and interactive improvised music-making. Over the course of the programme, a sense of camaraderie increased, alongside the enjoyment, and playfulness that developed. Amanda said, “This was a wonderful project to be a part of. By the end of the 12 weeks 71% of the participants’ recorded reduced ‘levels of distress’ compared to their CORE-OM scores when they signed up for the program. Worryingly, in 2019, Police Care UK reported 1 in 5 serving police officers were living with PTSD or anxiety disorders triggered by traumatic events. Similarly, mental Health charity ‘MIND’ surveyed 1600 staff and volunteer emergency service personnel and found 1 in 4 respondents had considered ending their own life and 63% considered leaving their role because of poor mental health or stress. Even more recently, the Police Federation of England and Wales published a survey where 77% of Police Officers responding reported mental health difficulties in the past year. The use of Music Therapy as a treatment modality for PTSD, anxiety and trauma related stress within ex-military in the US is well-documented. This research

THERAPY

formed the basis of the feasibility project to determine the efficacy of MT on emergency service workers who face trauma-like events throughout their daily working life. Blue Light Service employees from Surrey Police, Sussex Police, Surrey Fire & Rescue Service, East Sussex Fire & Rescue Service and South East Ambulance Service were offered a place in the programme. During the project, there were several participant withdrawals, which occurred within the range of “expected attrition” for such a project. Reasons for withdrawal are being considered as key Lessons Learnt for the next series of projects with other emergency services. Other factors included a lack of understanding of how music therapy would translate to help in everyday circumstances. These reasons demonstrate a stigma is still felt by emergency service personnel in seeking help to support their mental wellbeing - or to access alternative therapies for that same reason. Of the participants that did complete the project, they stated a positive reduction in symptoms, an increased sense of wellbeing and a sense of leaving therapy with specific coping strategies. In order to evaluate the effectiveness of the programme, participants completed a Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) questionnaire in the first and last sessions, an Outcome Rating Scale (ORS) at the beginning of each session, and a Group Session Rating Scale (GSRS) at the end of each session. Participants also completed the Patient Health Questionnaire (PHQ-9) and the Generalised Anxiety Disorder Assessment (GAD-7) online. After the fifth session, participants attended a 30-minute 1:1 session with Amanda to discuss the therapy and to recalibrate personal goals for the remainder of the program. Participants then had a final 30-minute 1:1 session, after the therapy ended, to review their progress and discuss any ongoing recommendations. Amanda Thorpe, music therapist who ran the project said, “I am an avid supporter of Music Therapy implementation as a treatment modality for trauma and am happy this pilot generated positive results. “Avoidant behaviour is a common symptom of PTSD. Musical improvisation through drumming demands an active response and despite feeling uncomfortable, resistant, and sceptical at the beginning of the program, each participant demonstrated a significant level of awareness, adaptability and resilience just by showing up. They were all willing to go outside of their comfort zone and to try something unknown.” Participant feedback revealed surprise at the benefits experienced, going outside of a comfort zone, learning different coping strategies, reduced stress. Many participants expressed a desire for the group to continue and requested they be contacted about additional programs for which they could sign up. Amanda continued, “It is our hope (myself, BLSO and Chroma) that in the future, music therapy becomes more widely available for emergency service personnel. Several participants felt the project was ending too soon as they were just starting to benefit from the group. Others stated the 1-hour duration was too short and was ending just as they were beginning to relax and engage. Longevity and duration are both factors that should be explored for future programmes.” Results indicate the Blues & Tunes music therapy pilot programme provided an effective therapy intervention that reduced PTSD related symptoms of attendees. The main benefits identified by participants were the use of drumming and guided meditation. There was a significant level of surprise amongst participants regarding the difference in their pre-conceived ideas of what music therapy would be, and what they actually experienced, suggesting a lack of awareness and understanding of the intervention modality. Group participants felt that the programme made a positive difference to their understanding and management of themselves and their symptoms. All participants commented on a shift in their sense of wellbeing after exposure to the programme and on having gained tools that they could take forward. This was supported by the data. With the success of the pilot project, it is hoped that the use of music therapy as a treatment modality for emergency service workers exhibiting PTSD-like symptoms could be widened.