Bioengineer James Collins says one of out every three senior citizens has fallen after age 65, and up to 20 percent of those falls have been serious.
That’s why, he adds, many older people fear falling more than they do dying.
But Collins, professor of biomedical engineering at Boston University, told hundreds of researchers and scientists at the annual meeting of the American Society of Biomechanics in Providence last month that he and his fellow researcher might have a remedy: vibrating insoles to assist the elderly and others such as stroke victims in balance control.
It’s a technology that’s been in development for more than a decade – including at a Providence biotech startup – but Collins told the gathering at the R.I. Convention Center in August that he’s hopeful that within a year or so, some form of the special insoles will hit store shelves.
Collins’ laboratory has “four different contractors designing and manufacturing prototypes,” he explained. “And they’re in discussions with Dr. Scholl’s as well as other shoe companies.”
It’s been a long time in coming, and there has been at least one casualty along the way. The Providence company that licensed the technology – Afferent Corp. – has since gone out of business after less-than-stellar clinical trials, not on the vibrating insoles but related technology.
Collins, whose talk at the biomechanics conference hosted by Brown University also delved into synthetic biology, said he first developed the idea of using noise, or weak vibrations on the soles of the feet to assist with balance control in the early 1990s after hearing a presentation on certain noise levels enhancing signal detection.
A colleague approached him afterward. “If you can come up with medical applications for the phenomenon, you’ll never have to write a grant again,” he told Collins. “They’ll send a dump truck of money every October.”
Soon Collins was thinking about touch sensation and how it deteriorates as people grow older, including on the soles of the feet.
For younger people, changing pressures on the bottom of the feet signal the brain to shift balance to prevent falling. For the elderly, the pressure changes are not detected as quickly, and the balance correction could come too late.
“This is a major contributing factor for balance and mobility issues in older people,” Collins said.
Could he use low-level noise, or vibrations, to enhance those touch sensations in the elderly?
The research began in spring 1994, with tests of mechanical vibrations on patches of rat skins. When those results proved promising, researchers moved to testing the elderly and young people, placing them on a platform with hundreds of contact points.
“What we found was all of the measures got better, and the peak occurred at a level the subjects could not detect,” Collins said. “So balance improved with the introduction of low amounts of noise.”
Collins and his colleague progressed to developing insoles with three quarter-sized motors that vibrated the gel-based contraption.
That initial version had its problems. The battery was much too big for an elderly person to use it, and the insoles themselves were too thick to place inside normal shoes.
But the tests continued to be encouraging. Collins said the balance of seven of every eight subjects improved significantly. “And the elderly improved more than the young,” he said.
Collins could envision the uses of this type of neuroscience going beyond the elderly and might encompass diabetics and stroke victims, among others. “There’s a host [of ailments] where there’s a real need to develop a host of sensory aids,” he said.
Jason Harry felt the same way.
In 2000, Harry licensed the technology from Boston University and launched Afferent, looking to develop a way to restore brain functions after a stroke, in addition to working on the balance-control applications.
Over the course of eight years, Afferent raised about $10 million in venture capital and research grants, said Harry, who was contacted after Collins’ talk.
A partnership with Stryker Corp., a large medical-technology company based in Kalamazoo, Mich., brought in more money.
Some of the improvements to the vibrating insoles – such as making the batteries smaller and the gel insoles thinner – were developed by Afferent, Harry said.
But the company, which had a staff of eight, was also running human clinical trials on sensor stimulation directly on the upper extremities of stroke victims at Harvard University-affiliated Spaulding Rehabilitation Hospital in Boston.
By 2008, the results were indicating there was no significant difference between those people undergoing the stimulation and those who weren’t.
“That happened at a particular point in the maturation of the company where we were in need of raising additional capital and [questionable] results made that difficult,” he said. “We ended up having to wind things down.”
Since the trials didn’t involve the vibrating insoles, that aspect of the technology still held promise.
“But the brutal reality was we didn’t have enough gas in the tank to switch strategies at that point,” Harry recalled. “The technology was and is extremely compelling. But neuroscience is a very difficult place for early-stage companies to be playing. It’s extremely capital intensive and filled with business and clinical risk.”
Collins said at the conference last month that the technology was picked up by Stryker but the company voluntarily gave back the vibrating insoles part of the patent because they didn’t intend to develop them.
Now the Boston-based Wyss Institute for Biologically Inspired Engineering, which is where part of Collins’ lab is located, is working to improve the insoles for use in the marketplace. Collins said the institute has invested $1.5 million.
The institute is going to try a different route than Afferent followed.
“We’re going to address the wellness market to try and go unregulated to start,” he told the conference attendees. •
