The FDA announced today that it authorized the Neurolutions IpsiHand upper extremity rehabilitation system for stroke rehab.
De novo authorization encompasses patients 18 years of age and older who are undergoing stroke rehabilitation to facilitate muscle re-education and need to maintain or increase their range of motion, according to a news release. It is a brain-computer-interface (BCI) device that assists in rehabilitation for stroke patients with upper extremity or hand, wrist and arm disability.
IpsiHand uses non-invasive electroencephalography (EEG) electrodes — instead of an implanted electrode or other invasive feature — to record brain activity. EEG data is then wirelessly transmitted to a tablet for analysis of the intended motor function and the signal is sent to a wireless electronic hand brace designed to move the patient’s hand.
The aim of the device is to help stroke patients improve grasping with their hands. It is currently prescription-only and may be used as part of rehabilitation therapy.
Clinical data submitted to the FDA by Neurolutions observed 40 patients over a 12-week trial. All participants demonstrated motor function improvement with the device over the course of the trial. Adverse events reported included minor fatigue and discomfort, along with temporary skin redness.
“Thousands of stroke survivors require rehabilitation each year,” acting director of the FDA’s Office of Neurological & Physical Medicine Devices Dr. Christopher M. Loftus said in the release. “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.”
