‘Bionic clothing’ to aid mobility tested for foot drop in MS patients

June 30, 2022 | by

A combination of smart clothing and an exoskeleton to aid those with mobility issues. The Neural Sleeve uses functional electronic stimulation (FES) to aid walking in those with multiple sclerosis (MS) and similar conditions. In a small clinical trial, it reduced foot drop, which is the inability to dorsiflex, or raise the front part of the foot, due to weakness or paralysis of the muscles in the front of one’s lower leg. This is seen in the gait of those with MS, traumatic brain injury, stroke, spinal cord injury, and cerebral palsy. (This Editor also knew someone for whom leg drop was an initial sign of a brain aneurism.) This disturbed gate dramatically increases fall risk.

The Neural Sleeve works through sensors in the sleeve that monitor movement for muscle firing and limb position, while the analysis, connected to the device through an app, determines the FES to activate the necessary muscles precisely coordinated to the gait cycle. The developer is Cionic, located in the Bay Area of California, still in seed rounds, but marketing to both physicians and direct to consumer. 

Of 34 final participants with a mixture of causes in a small clinical trial:

  • It improved foot angle in 96% of participants, a 3.4% increase in heel-toe time, and a 5.2% increase in dorsiflexion at heel strike
  • Inversion (turning in) of the foot also was reduced by 3.6 degrees on average.
  • After eight weeks of use, mobility improved 30% on average.
  • In addition, the number of patients reporting moderate to severe pain reduced by 60%, and the number reporting moderate to severe anxiety or depression dropped by 75%.

The clinical trial is in preprint 6 June in Medrxiv as Augmenting gait in a population exhibiting foot drop with adaptive functional electrical stimulation.

The Neural Sleeve received FDA Class II medical device clearance in March. However, it is still in pre-orders, selling out 2022, with 2023 to open later this summer. Multiple Sclerosis News Today, Medium post on foot drop in the Cionic blog, other Medium posts  Hat tip to TTA founder Steve Hards

Short takes: 2022’s big kickoff with Babylon-Higi, Vera-Castlight buys; will funding slow down in ’22, eye-tracking telehealth for MS, vital signs tracking lightbulbs at CES 2022, and three catchups!

January 7, 2022 | by

Babylon Health closed out 2021 by acquiring health kiosk Higi for an undisclosed amount. Babylon had earlier invested in Higi’s Series B [TTA 30 May 20] and was reported in October to be exercising its $30 million option to buy Higi after closing their SPAC. Release

Vera Whole Health, an advanced primary care provider and clinic group based in Seattle, is acquiring Castlight Health, a data and care navigation platform. Vera will acquire Castlight in a $370 million all-cash deal. Strategic partners and investors include Anthem, Morgan Health (the JP Morgan Chase & Co business for the transformation of employee healthcare), Central Ohio Primary Care, and Clayton, Dubilier & Rice funds. Former Aetna chairman and CEO Ron Williams will become chairman. Release.

Which leads to the usual question…will funding in 2022 continue the hot streak of 2021? It’s one opinion, but Lee Shapiro of 7wireVentures, formerly with Livongo, is sensing a slowdown, citing increased interest rates (money), the US midterm elections (which don’t affect the rest of the world), less new money, and investors wising up on the length of time any healthcare or health tech investment takes to pay off. 2021 with 79 digital health M&As plus an abundance of SPACs that tailed off by end of year will be hard to match. Mobihealthnews

XRHealth, a telehealth clinic that provides treatments in patients’ homes based on virtual reality treatment, has integrated Tobii‘s eye-tracking technology into the XR platform and the Pico Neo 3 Pro Eye VR headset. XR Health provides rehabilitative and pain management therapies via VR. The Tobii system will enable treatment using the headset for multiple sclerosis (MS), Parkinson’s, and other neurological conditions. According to the release published in Multiple Sclerosis News Today, “detecting subtle changes in eye movement can help diagnose these diseases at an early stage, as well as assess disease progression and response to treatment. Tobii‘s eye-tracking technology is able to detect those changes in real time, providing data and insights to clinicians during therapy sessions.” Hat tip to Editor Emeritus Steve Hards

CES 2022 is on this week, far less splashy than before as an in-person/virtual hybrid event. Debuting at CES is the Sengled Smart Health Monitoring Light. Looking like a standard LED lamp bulb, it contains sensors that network and can take passive vital signs measurements of sleep quality, breathing, heart rate, and motion of occupants in the home. The more bulbs the better, of course. Whether or not they can detect falls, as the article touts, is likely an inference on motion. They feed into either Alexa or Google Assistant, plus Sengled’s app, using Frequency-Modulated Continuous Wave (FMCW) radar operating in the 2.4 GHz range. Expect it to be coming out towards the end of the year and probably twice the price of conventional LED smart bulbs. TechRadar Hat tip to Adrian Scaife via LinkedIn

Catching up…

Walgreens and VillageMD continue on the ‘go big or go home’ highway with nine more Village Medicals at Walgreens in San Antonio, Texas. Plans are to build 600 Village Medicals at Walgreens in more than 30 markets by 2025, growing to 1,000 by 2027. HealthcareFinance

Centene, the health payer conglomerate, finalized its $2.2 billion acquisition of Magellan Health, a major behavioral health management company. It will likely be CEO Michael Neidorff’s swan song, as an activist investor forced his retirement (at age 78 after over 25 years at the helm) this year and significant board changes. Magellan’s former COO and president Jim Murray will become Centene’s chief transformation officer, a new position, lead what they term the Value Creation Office as well as the Centene Advanced Behavioral Health division. Forbes, Centene release

And suitors with a spare billion or so may be lining up to buy IBM Watson Health. The first offers came in on 4 January with the winner to be announced possibly by end of the month. IBM spent over $4 billion over time to build up Watson Health, but now wants out, badly. Axios

Telemedicine used in MS neuromodulation study at NYU Langone, with positive results (US)

February 28, 2017 | by

MS patients in a small NYU Langone Medical Center-led pilot of neuromodulation and cognitive training using telemedicine supervision experienced significant improvement in complex attention and reaction time. Non-invasive transcranial direct current brain stimulation (tDCS) was added to a previously tested cognitive training program for MS patients. Telemedicine (real-time video) was used to deliver the training, monitor patients in the program and provide follow-up support.

The study control was a cognitive training (CT)-only group. According to the abstract, “after ten sessions, the tDCS group (n = 25) compared to the CT only group (n = 20) had significantly greater improvement in complex attention (p = 0.01) and response variability (p = 0.01) composites. The groups did not differ in measures of basic attention (p = 0.95) or standard cognitive measures (p = 0.99).” These results corresponded to the stimulation area in the dorsolateral prefrontal cortex, according to the lead researcher Leigh Charvet, PhD.

The current used in the tDCS unit helps neurons fire more readily, versus making them fire. The tDCS unit used was likely provided by NYC-based Soterix Medical, a developer of neuromodulation systems used in clinical trials. One of the study authors, Abhishek Datta, PhD, is their CTO.

The research is also promising in helping to deliver therapy to MS patients at home, reducing the travel need on both sides, and to develop analytics to optimize medication. In future, the researchers hope to expand the study group to Parkinson’s disease patients. MedCityNews, Neuromodulation (the official journal of the International Neuromodulation Society; abstract only, full study requires additional access)