The US Food and Drug Administration (FDA) has authorized marketing of a new neurological rehabilitation device to assist in maintaining or increasing range of motion as part of muscle re-education in patients undergoing stroke rehabilitation. The device is approved for use in patients 18 years of age and older. More than 795,000 people suffer a stroke each year in the US, many of whom are left with serious long-term disabilities.
The device is called the IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) and has been developed by Neurolutions Inc., a medical device company focused on developing neurological rehabilitation solutions leveraging patients’ own brain activity to facilitate motor recovery and restore function.
The IpsiHand System is a Brain-Computer-Interface (BCI) device that supports muscle rehabilitation for stroke patients with upper extremity — namely hand, wrist and arm — disability. It essentially translates a patient’s thoughts (brain signals) of an intended movement into actual physical motion using a robotic brace and EEG-based headset.
With the authorization, the IpsiHand System becomes one of the first non-invasive neurological rehabilitation device to receive FDA approval in the rapidly growing brain-computer interface space. The only other approved interface is Blackrock Microsystems’ NeuroPort Array, an electrode device implanted in the brain that monitors and records neural activity for up to 30 days after implantation.
The device was granted De Novo market authorization, an FDA regulatory pathway for low- to moderate-risk devices of a new type. It also received Breakthrough Device designation from the agency, which allows for the expedited development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough designation may also streamline the process required for Medicare reimbursement.
“The approval of the IpsiHand System represents an important step forward in the care and rehabilitation of stroke patients,” said Leo Petrossian, PhD, CEO of Neurolutions in a statement. “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 neurological rehabilitation IpsiHand system consists of a biometric headset containing EEG electrodes, a robotic exoskeleton brace worn over the patient’s hand and wrist and a tablet computer. The headset records brain activity on the side of the brain that is not affected by stroke. The system then translates the brain signals from this uninjured, or ipsilateral, hemisphere of the brain, into movement of the exoskeleton. Thus, when the patient thinks about opening their hand, the device physically opens the patient’s impaired hand. In this way, a patient’s thoughts physically control their ability to open and close their hand, facilitating muscle re-education to assist upper extremity rehabilitation.
Data from the headset is sent to a tablet which deciphers the intended muscle movement; the tablet then sends a signal for movement of the hand brace to execute the motion.
“Thousands of stroke survivors require rehabilitation each year. Today’s authorization offers certain chronic stroke patients undergoing stroke rehabilitation an additional treatment option to help them move their hands and arms again and fills an unmet need for patients who may not have access to home-based stroke rehabilitation technologies,” said Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in a statement from the agency.
The IpsiHand System is available by prescription only and is designed for use at home or in a clinical setting as part of a prescribed rehabilitation therapy regimen.
The neurological rehabilitation device was developed by a team of innovators in Silicon Valley and neuroscientists from Washington University in St. Louis.
Neurolutions submitted clinical data to the FDA for evaluation of safety and effectiveness of the IpsiHand System device. This included data from an unblinded study of 40 stroke patients over a 12-week trial. Motor function improvement with use of the device over the trial period was demonstrated among all patients in the study. Adverse events reported included minor fatigue and discomfort, and temporary skin redness.
The growing brain-computer-interface space includes key players such as Elon Musk’s Neuralink, which is developing a brain reader chip implant that received breakthrough device designation from the FDA in July of last year. The FDA is, in fact, committed to supporting and accelerating the development of devices based on brain activity to treat conditions such as paralysis or amputation, and in 2019, issued a draft “leapfrog” guidance document outlining this goal.