Neurorehabilitation Firms Advance Stroke Therapies
by James Cavuoto, editor
April 2021 issue
Two emerging neurotechnology firms have recently reported progress developing new therapies for stroke rehabilitation. But the two firms are using markedly different approaches.
Neurolutions, Inc., a St. Loius, MO area startup, announced that the FDA granted de Novo market approval for its IpsiHand upper extremity rehabilitation system. The device has been cleared for use in chronic stroke patients to facilitate muscle re-education through its novel BCI platform. In addition to the de Novo approval, the IpsiHand device received breakthrough device designation from the FDA as well.
“The approval of the IpsiHand System represents an important step forward in the care and rehabilitation of stroke patients,” said Leo Petrossian, CEO of Neurolutions. “For the first time, we are able to combine advanced robotics with brain computer interface technology to augment traditional stroke rehabilitation, allowing patients to improve upper extremity function after stroke.”
The Neurolutions IpsiHand system is designed for home or clinic use as part of prescribed rehabilitation therapy. It includes a wearable robotic exoskeleton that is worn over the patient’s hand and wrist, a tablet computer, and an EEG-based biometric headset. The system translates brain signals from the uninjured, or ipsilateral, hemisphere of the brain, into movement of the exoskeleton. As a result, when the patient thinks about opening their hand, the device physically opens the patient’s impaired hand. This ability to physically open and close the patient’s hand based on the patient’s thoughts facilitates muscle reeducation, improving upper extremity rehabilitation.
Developed by a team of innovators in Silicon Valley and neuroscientists from Washington University in St. Louis, the neuro-prosthetic and robotic capabilities of the IpsiHand System have been shown in clinical trials to provide both statistically and clinically significant outcomes for chronic stroke patients.
There are approximately 6 million stroke survivors living in the U.S. Approximately 800,000 American adults experience a stroke each year, of which approximately 300,000 are left with upper extremity movement dysfunction. Muscular weakness or partial paralysis frequently persists into the chronic stage of stroke with 65 percent of chronic stroke patients reporting reduced motor function six months after stroke.
IpsiHand is indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. All participants in an unblinded 40-patient study over 12-weeks demonstrated motor function improvement with the device over the trial. Adverse events reported included minor fatigue and discomfort and temporary skin redness.
Meanwhile, MicroTransponder Inc., the Dallas, TX manufacturer of neurorehabilitation systems, announced that the pivotal clinical trial results for the company’s investigational Vivistim paired VNS system have been published in The Lancet. The publication reports that patients receiving Vivistim therapy showed two- to three times the improvement in upper extremity motor impairment and function compared to controls that received intense rehabilitation alone. The multi-center, double-blinded, randomized controlled trial enrolled 108 subjects that were up to 10 years post-stroke with moderate to severe upper extremity impairment.
Subjects in the study were randomized to either the paired VNS group (intense physical therapy paired with active VNS) or control group (intense physical therapy paired with sham VNS) and did six weeks of in-clinic therapy followed by three months of home-based therapy. After in-clinic therapy, subjects in the paired VNS group showed a 5.0 point improvement in the Upper Extremity Fugl-Meyer Assessment compared to 2.4 points in controls. The Wolf Motor Function Test score also improved after paired VNS compared to controls. After three months of home-based therapy, the number of participants achieving a clinically meaningful response in upper limb impairment after paired VNS was approximately twice that of controls. The study showed that participants who received paired VNS had clinically meaningful improvements in both motor impairment and function compared to controls. Improvements with paired VNS were also observed in quality-of-life measures. There were no unexpected adverse events or serious adverse events associated with the Vivistim system.