‘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

US Army researchers use sensors, gels to study, mitigate brain and body blast effects

January 18, 2017 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/01/ARL_tour-1024×819.jpg” thumb_width=”150″ /]US Army research labs have been leading the way for some years in researching how impacts, such as those experienced from explosive devices or other sources of concussion, can affect the brain and body. One tactic Army researchers in the Research, Development and Engineering Command (RDECOM) are taking is to engineer increased protection in ground vehicles (ground vehicle systems in Army-speak). However, testing designs can’t be done with humans. One method used is a sensor-laden crash dummy (Warrior Injury Assessment Manikin or WIAMan, seen above left). Fred Hughes, director of the WIAMan Engineering Office, commented that “The manikin’s sophisticated bio-fidelity and robust sensor design provides an unmatched level of accuracy determining the potential effects of blast on soldiers in new vehicle systems.” Another tool is the Microsoft-designed Hololens which allows researchers to virtually explore explosion simulations. Both are being used to assess survivability and mobility design in vehicles. Armed With Science

At another part of RDECOM located at the Aberdeen (Maryland) Proving Ground, US Army Research Laboratory researchers have simulated brain texture and mass through a specially designed gel. These nanomaterials are designed to fluoresce at graduated intensities under pressure. The goal is that researchers can track blast effects on the brain at the cellular level. ARL research in this area is jointly conducted with counterparts in the Japanese Defense Ministry, where researchers are contributing their knowledge of physiological effects such as cortical depressant, blood circulation and oxygen levels in tissue. ARL News, YouTube video. Both tracks of research are designed to protect soldiers in the field from TBI, and better understand the effects of blast-created trauma to the brain.

Mobile brain monitoring developments and impact (Israel)

September 28, 2016 | by

Accelerator/healthcare innovator StartupHealth’s ongoing series Startup Health Now! (#94) interviews Israeli entrepreneur Nathan Intrator, founder of Neurosteer, on developing new applications for brain monitoring in TBI cases, the impact home monitoring will have on patients and Israel’s burgeoning digital health scene. Highlights from the 18 minute video from this past June at Wearable Tech + Digital Health Conference, New York, NY include applications to monitor those who are minimally conscious to assist doctors in treatment; how data from remote patient home monitoring can detect early stage problems so that doctors can take proactive care, reducing cost and disruption; and Israel’s digital health ‘corridors’. Video

Sonde Health using voice as a biomarker for diagnosis

June 30, 2016 | by

Back in 2013, we profiled Max Little of the UK-based Parkinson’s Voice Initiative, who was in the fairly early stages of voice testing and analysis to aid early diagnosis of this disease. By 2015, he had over 17,000 voice samples, was partnering with the Michael J Fox Foundation, and was seeking to develop a non-invasive, quick, accurate test based on acoustic markers. Dr Little is an Oxford University PhD, currently a Wellcome Trust/MIT fellow at the MIT Media Lab. The Voice Initiative has additional support from PatientsLikeMe, Twilio and Aculabcloud.  But also developed at MIT, by Thomas Quatieri’s team at MIT’s Lincoln Laboratory, is a broader platform for voice diagnosis. This has been applied to mental health conditions such as depression, respiratory and cardiovascular conditions, and in pilots for TBI, cognitive impairment and…Parkinson’s. This has been licensed to Sonde Health, which hasn’t much on their website but is out of the Boston-based PureTech R&D/venture firm. The acoustic markers they cite are ‘dynamic changes in pitch and harmonics, articulation timing and hoarseness or breathiness that indicate and requires no analysis of words’. MedCityNews, MedTechBoston

Bioidentical, dissolvable brain implants for monitoring injury

February 27, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/02/1499.jpg” thumb_width=”150″ /]A pressure and temperature sensor which sits on the surface of the brain to monitor intracranial pressure and temperature changes has been developed by an international team from South Korea and the US. Currently, implantable sensors are used for monitoring victims of severe traumatic brain injury (TBI), but these sensors carry risk of inflammation and infection. In initial testing, this new sensor has been found to be fully biocompatible (no inflammation or scarring) and dissolves in a few weeks. It can also be modified in other ways to monitor other brain functions, such as acidity and the motion of fluids, or deliver drugs. Published in Nature. Summary in the Guardian.

 

 

Blood biomarkers to diagnose mild TBI; more studies on TBI, concussion

January 13, 2016 | by

An abundance of studies pointing the way to digital health opportunity. A surprise on the early morning radio news in NYC was mention of a report on a blood biomarker that could confirm a diagnosis of concussion, published in the Journal of Neurotrauma. Once found, it wasn’t exactly as advertised but the research is worth reviewing. First, it applies to mild TBI. The biomarker is the extensively studied glial fibrillary acidic protein (GFAP) versus another biomarker, S100β. The key finding by the central Florida-based team is that in a general trauma population, GFAP out-performed S100β in detecting intracranial lesions as diagnosed in CT scans. Scrolling down in the article is a link to the abstract of a meta-study of 11 biomarkers in concussion, by the same lead researcher and another team. The current featured articles in Neurotrauma are a stunning review of studies around concussion and TBI, including two very interesting articles on why air evacuation can do more harm than good (unless absolutely necessary) for TBI patients (altitude lowers oxygen levels) and how mild TBI suffered by retired NFL players has long-term negative metabolic and pituitary effects. All paywalled unless you have library access or a friend with subscription access; however some of the citation articles are open access. But for health tech developers looking for problems to solve better, cheaper and faster, here it is–a lot more promising than yet another me-too wearable. 

NIH funds in vivo CTE research with $16 million–$0 from NFL; “Concussion” released

December 23, 2015 | by

CTE research funded–and at a US theater near you Christmas Day

In the run-up to the holidays, our Readers may have missed another gift to those concerned with brain health–the National Institutes of Health (NIH) awarding of a major grant to fund research on chronic traumatic encephalopathy (CTE) to diagnose victims in vivo (while still alive). Awarded by NIH in conjunction with the National Institute of Neurological Disease and Stroke, the $16 million will go to researchers from Boston University, the Cleveland Clinic, Banner Alzheimer’s Institute (Arizona) and Brigham and Women’s Hospital in Boston. Leading the team is Robert Stern MD, Boston University professor and director of clinical research for BU’s Alzheimer’s disease and CTE centers, and a researcher we’ve followed since his June 2013 presentation at NYC’s German Center. According to a report in sports network ESPN’s ‘Outside the Lines’, the National Football League (NFL) refused to fund this research from their long term $30 million grant to the NIH due to Dr Stern’s alleged lack of objectivity; according to ESPN, a NIH official told ‘Outside the Lines’ that “the NFL’s $30 million gift was contingent on the league being able to veto decisions on projects that the money was funding.” Seemingly outside this research is another area of interest to Dr Stern–why some athletes have CTE, and others do not, as discussed in the May 2014 NYC MedTech ‘Brain Games’ presentation attended by this Editor.  Medical-Net (BU release), New York Times

Sports CTE and brain injury is back on the front pages with the release of the film ‘Concussion’, starring Will Smith as foundational researcher Bennet Omalu MD, the then-Pittsburgh forensic pathologist who uncovered CTE after performing a detailed brain examination of Pittsburgh Steelers center Mike Webster, who died of a heart attack aged 50 in 2002. His 2005 case report with others from University of Pittsburgh in Neurosurgery was the kick-off (so to speak) and so enraged the NFL that they attempted to have it withdrawn from the journal. In this interview with Medscape EIC Eric Topol MD, Dr Omalu discusses (more…)

TBI neuromodulation therapy in phase 3 trials with US Army

August 14, 2015 | by

Helius Medical Technologies and the US Army Medical Research and Materiel Command (USAMRMC) jointly announced the phase 3 trial of Helius’ mPoNS (Portable Neuromodulation Stimulator), a non-invasive brain stimulation device for the treatment of balance disorder in patients with mild-to-moderate traumatic brain injury. This commercializes the research of USAMRMC and University of Wisconsin-Madison we covered two years ago [TTA 28 Feb 13] in using electrical stimulation of the cranial nerves located in the tongue. The phase 3 study will be at three sites for seven months: the Montreal Neurofeedback Center, the Oregon Health & Science University Center for Regenerative Medicine, and the Orlando Regional Medical Center. The mPoNS is also being researched in Canada for treatment of gait and balance in multiple sclerosis. Press release

TBI, early brain aging and a seismic analogy

August 4, 2015 | by

Traumatic brain injury (TBI) has been receiving extra study in the past few years due to battlefield blast/IED injury as well as football and other sports injuries as early as junior high. The insidious nature of TBI is that long-term effects of accelerated brain aging can appear in those who have mild injuries, or who never experienced the usual symptoms indicating TBI such as dizziness, nausea and disorientation. Researchers have struggled for the reasons why “51 percent of sufferers of mild head injuries were reported as still having disability one year later at follow-up” and why a large proportion of military veterans who sustained mild brain injuries experience the heightened and uncontrollable emotionality of pseudobulbar affect (PBA). This article in the Genetic Literacy Project website works with an earthquake analogy: that there are P-waves (blast pressure) that compress tissues and disrupt neuronal communication, and in the long term accelerate brain aging and cognitive decline. Something sports injury, CTE researchers and research organizations within the military such as DARPA and DoD should be investigating. Hat tip to author and reader Dr Ben Locwin via Twitter.

An abundance of related reading in TTA can be found in searches under TBI and chronic traumatic encephalopathy. Also see our 2012 and prior archives for our writing on TBI.

Smartphone and sensors the latest ‘medic’ for diagnosing battlefield TBI

July 31, 2015 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/07/Ahead-200.jpg” thumb_width=”150″ /]Finally a more reliable device for combat medics to screen for TBI in the field. The US Department of Defense, before its EHR bombshell (so to speak) yesterday, issued this short Armed With Science article on a sensor-smartphone for quick field diagnosis of TBI. The FDA-cleared BrainScope Ahead 200 marries an Android smartphone with a headset and disposable sensors to measure brain electrical activity, The app in the smartphone then analyses the brain data using algorithms to correlate them to elements relating to TBI. Currently, most combat-related TBI tests are subjective, based purely on symptoms such as headaches, nausea and light sensitivity. The only ‘objective’ test would be a CT scan in a medical facility well off the front lines, which means time wasted in a definitive diagnosis. This is being implemented by the Army Medical Research and Materiel Command at Fort Detrick, Maryland.

Possible early detection test for chronic traumatic encephalopathy (CTE)

April 6, 2015 | by

A research study published today in the Proceedings of the National Academy of Sciences (US) presents the results of screening 14 retired professional American football players with suspected CTE. Using a tau-sensitive brain imaging agent, [F-18]FDDNP, the California and Illinois-based researchers were able to detect the abnormal accumulation of tau and other proteins, in the distinct CTE pattern, in the brains of living subjects who had received, during their playing careers, multiple concussions and head trauma. Of the 14, one had been diagnosed with dementia, 12 with mild cognitive impairment and one with no symptoms. Previous studies, such as Robert Stern, MD‘s pathfinding research at Boston University and for the NFL (see below), have been primarily post-mortem on brains donated for research, although Dr Stern’s last presentation at NYC MedTech and Inga Koerte, MD of the Ludwig-Maximilians-Universität München (LMU) have also used brain scan information on live subjects in their studies.

Where this differs is that the imaging agent injected binds to the tau  (more…)

Testing the ‘blast response’ of synthetic bone

August 26, 2014 | by

While protection against concussive and sub-concussive head blows that lead to brain trauma (TBI) and may lead long-term to chronic traumatic encephalopathy (CTE) is being developed in several areas, by DARPA, US Army research, universities and the NFL‘s helmet providers, the final test has to involve cranial bone similar to those belonging to 20-30 year olds. Testing on humans is out of the question, deceased animal and older human crania are dissimilar and surgical implants do not react like real bone.  The US Army Research Laboratory (ARL) along with university partners are developing synthetic cranial bone that behaves like real 20-30 year old bone when subjected to combat-intensity blasts, for testing devices to mitigate the adverse effects and/or track the effects of those blasts.  Armed With Science

Brain neuroprosthetics, stimulation for TBI, PTSD

August 11, 2014 | by

A signature injury of the Iraq and Afghanistan wars has been traumatic brain injury (TBI), as well as an outcome of all wars–post-traumatic stress disorder (PTSD). Over 270,000 veterans since 2000 have been diagnosed with TBI–along with 1.7 million civilians per year. The US Department of Defense (DOD) has been funding research in several areas to help veterans–and eventually civilians–with these traumas.

  • DARPA’s RAM: Restoring Active Memory program is seeking to compensate for brain injury by developing a neuroprosthetic to aid memory function. (more…)

More on DARPA’s ‘brain chips’ for PTSD, TBI

May 30, 2014 | by

DARPA’s continued research on deep brain stimulation (DBS) implants to treat PTSD and TBI, as well as other neuropsychological conditions, is given the once-over in this Defense One article. New information from the time this Editor last wrote about it in December is that the SUBNETS program (Systems-Based Neurotechnology for Emerging Therapies), funded with $12 to 26 million, will work with the University of California at San Francisco, Lawrence Livermore National Lab and Medtronic to create an implant with electrodes reaching into the brain and which does not require staying still under a machine in a lab. The prototype development is expected to take five years. The article also points out the US Air Force initiative studying the effects of low amounts of electricity on the brain to boost alertness delivered by an external cap.

DARPA’s brain injury ‘blast gauge’

March 25, 2014 | by

This Editor, as our long-term readers know, has been following the issue and the dangers of soldier TBI and PTSD for several years. One of the problems with TBI is measuring the amount of blast a soldier has actually sustained in battle–and thus the medical danger. A cheering development is the further development of the ‘blast gauge’ developed by DARPA and the Rochester Institute of Technology (RIT), the testing of which we noted in mid-2012 [TTA 12 June 12]. It is now smaller than a wristwatch (now thumb-sized) and worn in three positions attached to a soldier’s body armor: chest, shoulder and back of helmet. As in the wristwatch model, there’s a red-yellow-green light for an instant read, in addition to the downloadable data which a medic can interpret on a laptop using a USB cable. It is now being worn by 11,000 US troops and 1000 Australian soldiers in Afghanistan. (more…)

NIH-NFL research grants on brain injury awarded (US)

December 19, 2013 | by

In September 2012, the National Football League (NFL) donated $30 million to the Foundation for the National Institutes of Health (FNIH) to focus on brain injury. The Sports and Health Research Program (SHRP) now has a somewhat wider scope inclusive of joint diseases, sudden cardiac arrest, sickle cell anemia and hydration/heat injury. Last week they announced eight projects to be supported. Two ($6 million each) are cooperative agreements focusing on brain injury and after multiple concussions. These research projects are:  Boston University, which has pioneered major CTE research [TTA 5 June], and the VA on CTE; the pathology of CTE and delayed TBI from Mount Sinai Hospital in New York City. The six other studies are ‘pilots’ totalling about $2 million over two years and range from cortical GABA in pediatric sports concussion, the Spot Light concussion management app developed by Inlightened, LLC, and eye movement tracking for concussion detection. FNIH release