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PoNS supporting MS patients in the US

The roll-out of the pioneering device follows the successful delivery of outcomes for patients in Canada since 2019

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The pioneering PoNS device, which uses breakthrough technology to help patients with Multiple Sclerosis (MS) correct their gait deficit, has now been rolled out into the United States as its global expansion continues. 

The Portable Neuromodulation Stimulator (PoNS®) is now available to patients in the US on prescription, with its impact having been shown in Canada since 2019 in supporting with gait deficit and helping MS patients to walk. 

Research shows that gait deficit is a central cause of mobility, disability and quality of life issues for the 70 per cent of the one million patients with MS in the US.

And through the introduction of the PoNS – which has received FDA authorisation for its use in short-term treatment of gait deficit due to mild to moderate symptoms of MS – a new solution is now available to improve patients’ lives, redefining traditional rehab potential and opportunity 

Helius Medical Technologies, the creator of the PoNS, is also looking to introduce its device for the treatment of dynamic gait and balance deficits as a result of stroke, having secured FDA Breakthrough Designation for the PoNS. 

PoNS is a portable, non-implantable device that delivers mild electrical stimulation to the surface of the patient’s tongue. The device consists of a controller and a mouthpiece that contains gold-plated electrodes. The controller goes around the neck and the mouthpiece rests on the front of the tongue with the electrodes facing the tongue.

 

Electrodes send mild electrical impulses to the tongue which stimulate two cranial nerves that have direct connections into the brain through the brainstem. 

When combining the PoNS device with physical activity, PoNS therapy provides a neuromodulatory effect and sets off a cascade of activity in the brain that result in consolidated neuroplastic changes and therapeutic functional outcomes, improving gait deficit in MS patients.

“We believe that we are unlocking the full potential of neuromodulation and neuroplasticity to help MS patients walk more steadily and safely,” said Dr Antonella Favit-Van Pelt, Helius’s chief medical officer. 

“Approximately 40 per cent of individuals with MS will need walking assistance within 15 years of the onset of the disease. PoNS therapy provides a unique opportunity for these patients to improve gait functionality and mobility.”

The roll-out in the US is the latest milestone in the development of PoNS and its ability to support patients with MS in increasing locations around the world. 

“We are extremely excited that the first patients in the United States have purchased the PoNS device on a cash pay basis to begin treatment,” says Dane Andreeff, president and CEO of Helius.

“Production of the first run of the US commercial version of PoNS systems completed earlier this month and we’ve already received 19 prescriptions. 

“Two patients have received their PoNS devices to start therapy and we expect to be fulfilling additional prescriptions in the coming days and weeks.

“This is a tremendous milestone for the company as well as the nearly one million people in the US suffering from MS, and we look forward to bringing this important treatment to patients who need it. 

“As previously disclosed, we expect prescriptions in the U.S. to remain on a cash pay basis for the foreseeable future as we pursue reimbursement from third-party payers and CMS. We are pleased with the reception we are receiving during the launch.”

MS

Support for MS symptoms ‘must be offered at diagnosis’

Non-pharmaceutical help from clinicians should not be delayed, new research recommends

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Clinicians should offer non-pharmaceutical help for symptoms like pain, fatigue, depression or anxiety at the time of diagnosis for patients with multiple sclerosis (MS), rather than wait, new research has recommended. 

A new study has shown that clinically-significant levels of pain,  experienced by 50 per cent of patients; fatigue for 60 per cent; depression for 47 per cent; and anxiety for 39 per cent were regularly seen for patients within the first year after diagnosis. 

“The take home was that we found these symptoms, pain, fatigue, depression and anxiety quite prevalent at the point of diagnosis,” said Dr Kevin Alschuler, principal investigator of the UW Medicine study. 

“We want to address this immediately, rather than five or 10 years down the road.”

The findings also indicated that prompt screening was necessary if quality of life was to be maintained and optimised.

Globally, more than 2.3million people have been diagnosed with MS, a disease for which there is no cure and results from the body’s immune system attacking the brain and spinal cord, damaging the myelin which disrupts signals to and from the brain. 

In a further study from UW Medicine, the quality of life for MS patients was explored immediately after, at two months, three months, six months, nine months and then a year after diagnosis. 

The results of the study showed that, on average, quality of life was largely stable throughout the year – a finding that surprised researchers.

“Patients who are newly diagnosed have to deal with the emotional impact of the diagnosis, as well as numerous tests and treatment decision-making,” noted Dr Alschuler, who was lead author on the study.

“Results showed that, on average, if they came in and were doing great at diagnosis, they had a tendency to stay that way throughout the first year.

“If they were struggling, they also tended to stay that way.”

Many times, patients had been dealing with the symptoms years before a formal diagnosis, both noted.

“Through symptom self-management, including cognitive behavioral therapy, we help patients become empowered with coping skills, especially in the areas of fatigue and pain,” said Dr Dawn Ehde, a co-author on the quality of life study.

“We teach them how to use strategies such as relaxation or mindfulness meditation techniques, as well as how to pace themselves to decrease fatigue and better manage stress. 

“Patients who learn these skills often find that not only do their pain and fatigue go down, they are able to do more of what is important to them despite their MS.”

The next step for the team is to explore options for early interventions to help newly diagnosed patients.

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MS

‘Promote aquatic exercise for MS patients’

Barriers to participation must be reduced to ensure the wellbeing of people with Multiple Sclerosis, a report recommends

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Barriers to exercise – and particularly aquatic exercise – for patients living with Multiple Sclerosis (MS) should be reduced, a study concluded. 

Many people with MS report difficulties engaging in traditional land-based physical activity due to heat sensitivity and physical disability, meaning aquatic exercise is often a suitable alternative. 

In new Kessler Foundation research, 100 per cent of people with MS who had tried aquatic exercise said they preferred it to land-based alternatives. 

However, their participation has been impacted by the COVID-19 pandemic. 

The study found that while 56 per cent of people participated in exercise during the restrictions, only seven per cent took part solely in aquatic exercise. 

Although that was the preferred option by individuals with experience with this type of exercise, lack of access to pools and the costs associated with access were significant barriers.

Now, as we move on from the pandemic, the study’s authors have urged barriers to be removed from MS patients’ participation in aquatic exercise. 

“Clinicians should encourage their patients with MS to resume exercising as pandemic restrictions ease,” said Dr Helen Genova. 

“Given the benefits of aquatic exercise for people with MS, and the finding that it was preferred, it is worthwhile to look at reducing barriers to this type of exercise. 

“Encouraging community organisations and health and wellness programs to sponsor affordable aquatic exercise activities for people with MS would lower the barriers for participation, especially for the economically disadvantaged.”

Available treatments for MS have limitations in terms of symptomatic relief of the array of physical and cognitive symptoms experienced by many individuals, which has spurred interest in the role of health-related behaviours in minimising MS-related disability. 

As a health-related behaviour with known benefits on gait, balance, mood, and fatigue, exercise is a key topic in providing some antidote. 

In the study, researchers conducted an online survey of 179 individuals with MS about their exercise activities from October 2020 to April 2021, which established a general decrease in levels of activity, but also highlighted the importance of water-based activity in people’s lives. 

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MS

Could childhood trauma lead to MS in women?

The links were strongest with sexual abuse and for those who experienced several forms of abuse

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Childhood trauma may be linked to a heightened risk of multiple sclerosis (MS) in later life among women, new research has found. 

The associations were strongest for sexual abuse and for experience of several forms of abuse, the findings show.

The evidence suggests that childhood trauma can alter the immune system and may increase the risk of autoimmune disease. 

Abuse, neglect, and a chaotic home life are also associated with a heightened risk of poor mental and physical health in adulthood. 

In this study, researchers drew on participants in the nationally-representative Norwegian mother, father and child cohort study.

Nearly 78,000 pregnant women joined the study between 1999 and 2008, and their health was monitored until the end of 2018.

Information on childhood abuse before the age of 18 was gathered through questionnaire responses, while confirmation of MS diagnoses was obtained from linked national health registry data and hospital records.

In all, 14,477 women said they had experienced childhood abuse while 63,520 said they hadn’t. 

The women with a history of abuse were more likely to be current or former smokers – a known risk factor for MS – to be overweight, and to have depressive symptoms.

Some 300 women were diagnosed with MS during the monitoring period, nearly 1 in 4 of whom said they had been abused as children compared with around 1 in 5 of those who didn’t develop MS. 

After accounting for potentially influential factors, including smoking, obesity, educational attainment, and household income, the team concluded that women who had been abused as children were more likely to be diagnosed with MS.

The observed association was strongest for sexual abuse (65 per cent heightened risk), followed by emotional abuse (40 per cent heightened risk), and physical abuse (31 per cent heightened risk).

The risk was further increased for exposure to two categories of abuse (66 per cent heightened risk), rising to 93 per cent for exposure to all three categories, indicating a ‘dose-response’ association, suggest the researchers.

Similar results were obtained after the researchers excluded women who might have been in the early (prodromal) phase of MS when obvious symptoms had yet to appear.

And the association also persisted when women who had already been diagnosed with MS at the start of the study were included.

“Better understanding of the risk factors and timing of risk exposures, may open doors for prevention and give further insight to disease mechanisms,” the researchers conclude.

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