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Trials underway of breakthrough BrainQ technology

Results could be a ‘game changer’ for stroke patients in their rehabilitation, following success of pilot trials

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Trials of BrainQ technology, which could be a “game changer” in the rehabilitation of stroke patients, are now underway. 

BrainQ has enrolled the first patient into its pivotal EMAGINE trial, which will evaluate its electromagnetic field treatment in supporting the recovery of people from ischemic stroke. 

The EMAGINE Stroke Recovery Trial provides a remote and decentralised care model which will enrol 150 people between four and ten days following a stroke across up to 19 academic sites across the United States. 

It comes following the success of BrainQ’s pilot trial, which saw 77 per cent of patients reporting either no symptoms or minor symptoms following its therapy, with no significant disability, scoring one or even zero on the modified Rankin Scale (mRS), the gold standard for measuring global disability.

Additionally, over 90 per cent of people improved by two or more mRS points through the use of BrainQ’s technology. 

The EMAGINE study is designed to allow for participants to receive the BQ therapy beginning during acute hospitalisation, and then supporting them into inpatient rehabilitation and community or home settings. 

The trial, which will include 45 hour-long sessions over nine weeks, five times a week, will be operated remotely with the assistance of a care giver and will be remotely monitored by a therapist. 

Currently, effective treatment options exist primarily in the first few hours following a stroke, and only for around five per cent of survivors. 

BrainQ has spoken to NR Times previously about its ambition to extend this window of opportunity for reducing disability from the acute phase to the sub-acute phase, giving significant hope to people living with the effects of stroke. 

The BrainQ wearable device

“With one in four adults expected to have a stroke in their lifetime, and few options on the market for reducing disability, this trial has the potential to make a significant impact on the ever-growing population of stroke survivors suffering from long term disability,” said Yotam Drechsler, CEO and co-founder of BrainQ. 

“Recruiting the first patient is just the first step to unlocking new opportunities for survivors and helping to meet this huge unmet need.

“We hope to continue strong recruitment for our trial over the next year.”

“Over the past two decades we have made major advances in acute stroke treatment. But still 90 per cent of stroke patients experience long term disability,” said Dr Jeffrey Saver, director of the UCLA Comprehensive Stroke and Vascular Neurology Program, and a co-lead principal investigator for BrainQ’s pivotal trial.

“Advances in recovery are the next frontier for the stroke community.

“Success of this study would be a game-changer for stroke recovery and help pave the way for a new standard of care for stroke.”

“For many years, stroke rehabilitation has lacked novel technologies that change the treatment paradigm for patients,” added Dr Pamela Duncan, professor of neurology at Wake Forest School of Medicine and a co-lead principal investigator of BrainQ’s pivotal trial. 

“There is a potential that BrainQ’s therapy, coupled with exercise training commencing within a few days of stroke and continuing for nine weeks, will optimise recovery and reduce stroke disability.”

Tech

Fourier Intelligence continues international collaboration

The rehab robotics pioneer has signed a MoU with Centro Europeo de Neurosciencias

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Rehab robotics unicorn Fourier Intelligence is continuing its work in advancing the fast-growing sector by forming a new partnership with Centro Europeo de Neurosciencias (CEN). 

The signing of the Memorandum of Understanding (MoU) will focus on the testing of new and existing rehabilitation robotic devices created by Fourier Intelligence. 

Fourier Intelligence robotics are already in use around the world, with testing and feedback undertaken continually to ensure they are best equipped to improve patients’ lives and deliver the highest standards of rehabilitation. 

With a track record of healthcare excellence and research, working alongside international partners, CEN already makes an important contribution on a global scale and will be a key partner in the further development of Fourier Intelligence’s portfolio of life-changing devices. 

The MoU is the latest to be signed by Fourier Intelligence with key global partners, as part of its commitment to working in collaboration with experts around the world to create world-leading rehab robotics. 

“The agreement of this MoU is another significant step in the ongoing development of rehabilitation robotics, which will improve patients’ lives,” says Zen Koh, co-founder and group deputy CEO of Fourier Intelligence. 

“CEN has an excellent international reputation and track record in healthcare and research, and we are delighted to partner with them in this way. The testing of new and existing Fourier Intelligence devices is critical to maximising patient outcomes, so this will be very important in achieving that.

“We believe collaboration is at the heart of developing this sector and making a difference in the lives of those who need this technology, and are very proud to have key partners around the world. Together, we will take this forward and make the positive change that is needed.”

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Tech

The patience of patients

Stroke survivor Lisa Beaumont reflects on her ongoing rehabilitation and the vital role NeuroProactive can play

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Rehabilitation cannot be rushed. Each patient needs to develop techniques to build the patience they need.

In Spring 2022, I faced the biggest setback in my rehabilitation journey so far. A problem with my leg splint meant that I was unable to walk for two to three months.

I learned plenty about myself during this interlude. While my orthotic was being replaced, I watched from my window while Spring became early Summer.  I could not leave my bedroom for several weeks. Most importantly, I learned about my techniques for managing my frustration with my situation.

I had plenty of time to reflect upon my situation and to consider ways that might avoid this situation happening for others. Access to digital solutions such as neuroproactive.com from the outset will offer solutions for the patients of the future. 

For the last eleven years I have focussed my energy on learning to walk again. Therefore, it took a substantial adjustment physically and mentally for me to adapt to being confined to one room without any possibility of walking anywhere. I chose to focus on two activities which were possible for me to do.

Firstly, I could still develop my cognitive rehabilitation through game-playing. I found several games I could play on my phone, including Wordle, Words with Friends and Solitaire. 

I realised that Solitaire, also known as the English card game Patience, makes a good analogy for any rehabilitation journey. There is only one player in the game, and you can win or lose depending on your actions and choices. You cannot speed up the pace of the game, but you at least know where you are.  

Likewise, in rehabilitation. Neuroproactive.com offers features that would have avoided some of my frustration this Spring. It enables speedy communication between clinicians and patients. I would have had an opportunity to track the progress of my replacement splint. And it would have been a single place for the orthotist, physiotherapist and district nurses to discuss my case.

I realised that a strength of neuroproactive.com is that it recognises the central role that a patient has in their rehabilitation journey.  Consequently, the platform validates the patient’s experiences by giving them the ability so see and to help manage the input they need from their team of clinicians.

The other second activity was that part of the physiotherapy that I could still do – exercises in bed and upper limb work.  My carers supported me by helping me to count and record my repetitions and by monitoring the quality of my movements.

How could neuroproactive.com have helped to improve my situation? My situation could potentially have been avoided through better
communication between my orthotist, physiotherapist, GP and my team of carers. Neuroproactive.com can act as a single shared space for each person to share updates and photos.  

As more practitioners gain access to, and familiarity with, Neuroproactive.com and its features, new and exciting ways to use it will emerge.

We’re in the process of rolling out Neuro ProActive to 31 NHS Trusts.

You can find out more online www.Neuroproactive.com or connect with us on Twitter @NeuroProActive.

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Tech

ONWARD – making the impossible possible

CEO Dave Marver discusses its pioneering work in spinal cord injury and the new hope for people living with paralysis

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Professor Gregoire Courtine, Dr Jocelyne Bloch, Dave Marver

The concept of three people living with complete paralysis regaining the ability to walk independently is something that, in the very recent past, would have been dismissed as being impossible – but through the work of ONWARD, this one-time ‘impossibility’ is now becoming reality. 

For years, spinal cord injury has been regarded by many as the ‘graveyard of neuroscience’, where hope was in short supply and the outlook for those daring to dream of the day that may change was bleak. 

But now, through the efforts of pioneers who have led the research breakthroughs that are now shaping reality, the ability of technology to change lives is being seen by the whole world, with people watching in amazement as paralysed patients rediscover the ability to move. 

After being implanted with spinal stimulation technology developed by ONWARD – the first time its epidural electrical stimulation (EES) had been trialled in humans – all three participants who were part of the STIMO-BRIDGE trial were able to take steps independently within a single day.

After five months of rehabilitation, they were also able to use their legs to stand, walk, swim, and/or cycle. They also regained control of their trunk muscles. 

Such colossal steps forward in SCI are now giving new hope to people living with paralysis – and are helping to show, rather than being impossible, what could become the new possible for the future. 

“We were very pleased with the results of STIMO-BRIDGE, although we as a company are not going to be pleased with just impacting subjects in a clinical trial,” Dave Marver, CEO of ONWARD, tells NR Times. 

“Our job and our unique role is to scale these therapies so they can provide benefit to hundreds of thousands of people with spinal cord injury around the world. 

“These results show great promise, but we still have a tremendous amount of work to do to achieve our vision.” 

And for ONWARD, that vision is to change the lives of people living with SCI globally, to enable them to enjoy and live their lives in the ways that matter most to them. 

Established in 2014 to focus specifically on SCI, the venture has led truly groundbreaking research into this long-underserved area. 

Founded by neurosurgeon Dr Jocelyne Bloch and Professor Gregoire Courtine, Swiss-based ONWARD has taken decades of research and translational science to bring to fruition two viable commercial solutions. 

With its ARC EX and ARC IM devices, ONWARD – backed by many of the leading European life sciences venture capital investors – has led the charge on redefining the outlook for SCI patients. 

Its ARC IM, recently subject to the STIMO-BRIDGE trial, consists of an implantable pulse generator and lead that is placed near the spinal cord, controlled by wearable components and a smartwatch. A pivotal trial is set to begin within the next 12 to 18 months. 

The ARC EX is an external, non-invasive wearable stimulator and wireless programmer, which targets the rediscovery of upper body movement. Currently subject to the international Up-LIFT trial – the largest SCI trial of its kind – it completed enrolment of 65 participants ahead of schedule, despite the many challenges presented by the COVID-19 pandemic.

Currently being trialled at sites across the world – including in the NHS Greater Glasgow and Clyde (NHSGGC), as well as Neurokinex sites in England – the aim, pending necessary approvals, is for a commercial launch in the first half of 2023. 

But while the excitement at the potential of ONWARD is palpable, with the first introduction of its technology into rehabilitation centres across the United States, UK, France, Germany and the Netherlands potentially barely a year away, Dave is keen to ensure expectations remain realistic.  

“Certainly this will give hope to people, and I think the fact we enrolled all 65 subjects in Up-LIFT ahead of schedule, despite all the challenges of clinics closing and difficulties with quarantines and so forth, speaks to the enthusiasm that the clinical community has for this therapy,” he says.

“They have really embraced it, as the participants did in STIMO-BRIDGE. We, and they, are showing what is possible. 

“But I do think it’s important to not overstate it, I don’t want to create false hope, because these subjects really committed themselves to the therapy and to the rehabilitation process. 

“I think there is great potential that many people with paralysis will be able to stand again with the benefit of our therapies, maybe take some steps. But then it really depends on their particular circumstances and their overall level of health, their willingness to commit to rehabilitation, whether they can go further than that. 

“And, of course, not everyone with spinal cord injury, desires necessarily to walk again, they may have other priorities. And that’s why ONWARD is also committed to addressing other challenges that affect the quality of daily life, such as blood pressure and trunk control and use of better use of the upper extremities. 

“And then in the future, we’ll be looking at incontinence and restoration of sexual function, the whole battery of things that people with SCI have to contend with.”

Through its longstanding and deep-rooted commitment to the SCI community, ONWARD has secured relationships with of some of the world’s leading organisations in this area, including the International Spinal Research Trust and the Christopher & Dana Reeve Foundation. The latter has even become ONWARD shareholders, to help further its pioneering work. 

For Dave, while the word ‘pioneering’ is well-used, for ONWARD, it is also well-earned. 

“I think we are seen as pioneers in this area because we’ve chosen to focus on serving the spinal cord injury community,” he says. 

“It’s a smaller population than other populations with movement-related challenges, like stroke and Parkinson’s, for example. Most businesses orientate toward the largest potential markets, whereas our founders really had a passion for helping people with spinal cord injury. 

“And that remains the core vision, that was their raison d’être, and it’s with that commitment and determination that we have achieved such progress. 

“We haven’t partnered with existing spinal cord stimulation companies, we’ve developed our own technology platform that is built for the specific purpose of not stimulating the spinal cord for pain management, but stimulating the spinal cord to restore strength and function.

“But I think the progress we have made also reflects the close collaboration that we enjoy and value with our scientific partners. We have a group of people so committed and driven by our mission, which I think is why we make the progress we have done. 

“We develop that lead together in a very rigorous way, with our vision at the heart of that.”

Constantly looking to the next innovation and how its technologies can be even more beneficial to those who need them, ONWARD is also considering how, post-commercial launch, its ARC EX could be used remotely. 

“Later, we’ll be seeking approval for it to be used in people’s homes, so they can conduct periodic sessions maybe once or twice a week in their homes to continue gains that they have observed in the clinic, and build on those gains,” says Dave. 

“We’ll be looking at a successor study to Up-LIFT which would look at safety and performance when used in the home. 

“Without question, it’s important with spinal cord injury to be able to operate this technology, which is why we were keen to incorporate voice activation into the system. Both of our platforms can be programmed by the clinician, but in the future may be operated by and used by the injured with their voices. 

“But very importantly, we do our best to connect as frequently as possible with people with injury to inform the design of our product platforms, and inform our future direction as a company. 

“We consider ourselves part of the community, so that feedback to ensure the design of our technologies is really usable and accessible, in my view, is vitally important.”

And with such huge advances and new-found hope for the future, many conversations have turned to whether SCI may be curable. 

“I wouldn’t rule anything out, with human ingenuity and so forth, but what I would say is more realistic at this point is to have optimism – quite a bit of optimism – that movement and strength and function can improve, and in some cases, be restored with the benefit of therapies like ours,” says Dave. 

“Perhaps other therapies and technologies will emerge, if you look at how far we have come. But for us, our vision is to support the SCI community around the world through our therapies, and we’ll continue to do that. 

“We’re making steady progress across all areas of our plan, and while what we’re doing is difficult and complex, I’m confident we will come through.”

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