Wearable walking aids for MS are on their way

Ian Cook discusses exciting technology from across the pond helping MSers to walk

Anyone who has watched the rapid development of ‘exoskeletons’ and ‘exosuits’ in the US will be excited by news that wearable walking aids are now being developed over there, paving the way for their arrival over here in the UK.

The latest and most exciting new walking aid is the ‘Neural Sleeve’, made by US bio-tech company Cionic. In 2022, the Neural Sleeve was cleared for use in the US by the Food and Drug Administration (FDA), becoming the first high tech wearable bionic clothing aid for mobility impairment to win US federal clearance.

The Neural Sleeve is a flexible, lightweight leg-worn device, available in several sizes and has multiple sensors that allow it to evaluate, predict, and improve a user’s movement. It can be worn on one or both legs, dependent on the extent of walking difficulties.

Clever stuff

The device can read signals sent from the brain to the muscles and then electrically stimulate muscles to make real-time adjustments with each step to produce a more natural walking movement. A smartphone is used with the device to customise and modify settings, switch between programmes, and meet-face-to-face with Cionic mobility specialists via the built-in telehealth platform. One research study evaluated the Cionic sleeve’s efficacy and found patients’ ability to lift their toes markedly improved. Participants also saw reduced turning in of their feet during walking.

Case study

One US Neural Sleeve user Patty Glatfelter, 69, pictured at the top of this article, who has had MS for 37 years and was a physical therapist for 48 years, says the Neural Sleeve has improved her energy levels massively because walking is no longer such an energy-sapping struggle. Patty says her walking movement (her gait) is much smoother and thus far more energy efficient. Her story is one of several told with an accompanying video showing her walking, which are posted on the Cionic website.

Anyone watching Patty walking, and listening to her story, will be impressed by how far electrical stimulation has progressed since FES (functional electrical stimulation) devices first became available in the UK about 15 years ago. FES is where two small sticky electrode pads are placed on the side of the leg, on skin above the nerve running through the calf muscles. These pads are then battery stimulated, causing muscles that lift the foot to contract. A small switch is placed under the heel of the shoe and used to turn the stimulation on and off while walking, making walking safer, faster and less effort. The only limitation of traditional FES is that it stimulates just one nerve.

A breakthrough

To really improve walking, far more nerves than one need to be stimulated. This is where the Neural Sleeve comes in. The Neural Sleeve delivers FES to the four major muscle groups of the leg through 24 individual electrodes. As well as this, it provides several sensors which continuously monitor leg movement in real-time to monitor muscle firing and limb position. The system then adjusts timing of stimulation every step to match the wearer’s own walking pattern.

Things are moving quickly with the Neural Sleeve with a production plant in California licensed to supply 47 US states, with more than 400 clinics or healthcare institutions ‘prescribing’ the garment. Cionic recently also announced it had raised an additional $12 million financing, which it would use to increase the sleeve’s adoption among patients and expand its use for other conditions which affect walking, not just MS, although the company added that MSers will be a key group to see benefit. As well as supplying the device, Cionic also provides training for US patients.

Anyone wishing to see the difference the Neural Sleeve can make to walking in MS, can look at the company’s website which shows films of five US MSers with mobility impairments using the device. As well as Patty, mentioned above, the other four MSers are Daryl, Jim, Sharon and Sarah who wears Neural Sleeves on both legs. You can see the five walking using the neural sleeve at https://cionic.com/community.

Finally, UK MSers will doubtless want to know when will the device become available over here. In order to get UK approval, Cionic will first have to satisfy the requirements of the UK’s MHRA (Medicines and Healthcare Regulatory Authority). New applications typically take 90 working days to process. The next regulatory body to be satisfied in the UK is NICE (National Institute for Health and Care Excellence) who will need to be satisfied about not only its safety and efficacy but also that the neural sleeve is a ‘cost-effective intervention’ in order to make it available for NHS patients. NICE aim to publish final guidance for all new technologies within 90 days of receiving marketing authorisation. In theory, and following all necessary approvals, the neural sleeve could be available on the NHS within six months of an application being made to the MHRA and NICE. There is not yet a timeline for when the application will be made.

Paying privately

For those who want to go down the private route, the key issue is likely to be cost. US pricing structure gives some indication of how much a private patient in the UK might pay. In the US, there is currently a $260 (£200) down payment followed by $260 (£200) per month for the first 12 months, which covers the Neural Sleeve, expert care from a Cionic Mobility Specialist, electrodes as needed, access to all new exercises and activities, and warranty repairs. From year two onwards, the current cost is $120 (£100) per month which includes expert care from a Cionic Mobility Specialist, electrode gel pads as needed, access to new exercises and activities, and warranty repairs. VAT is generally not levied on medical appliances.

Just watching Patty and the other MSers, it’s clear the Neural Sleeve is already making waves on the other side of the Atlantic. It is surely only a matter of time before MSers start to witness a similar sea change in walking aids available over here. That day can’t come soon enough for MSers like me.

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