The FDA has cleared a medical device that uses brain-computer interface technology and a robotic exoskeleton to enhance rehabilitation in stroke patients. The IpsiHand System by Neurolutions received De Novo authorization from the FDA, indicating the technology is the first of its kind to be brought to market.
Cleared for muscle reeducation in chronic stroke patients over the age of 18, the FDA also granted IpsiHand a Breakthrough Device designation. This designation, among other benefits, fast-tracks the new device for Medicare coverage because clinical evidence suggests that it’s more effective than existing treatments. A stroke can damage neurons in the brain that control movements. The IpsiHand system enhances “muscle reeducation,” a rehabilitation process that trains the muscles to respond to movement signals from the healthy side of the brain.
Stroke patients who use the IpsiHand system insert their hand and wrist into a robotic exoskeleton that looks a bit like a handheld vacuum cleaner attached to a wrist brace. The patient also wears a biometric headset, which uses electroencephalography (EEG) technology to record brain signals. A tablet device rounds out the IpsiHand system; it communicates with both devices, structures the therapy session, acts as a user dashboard, and transmits data to the cloud.
When the user thinks about moving their hand, the tablet picks up signals from the uninjured part of the brain and analyzes the signals. The program then transmits the intended motion to the exoskeleton. The exoskeleton then stimulates muscle contraction, thus connecting the healthy brain area with the successful movement of the hand and forearm. Over time, therapy with IpsiHand results in muscle reeducation. Clinical data submitted by Neurolutions to the FDA included a study in which all 40 participants showed motor function improvement over 12 weeks of therapy.
IpsiHand was developed by a multidisciplinary team that includes experts in neurosurgery, nanotechnology, biomedical engineering, occupational therapy, neuro-rehabilitation, and electrical engineering. Neurolutions intends for the IpsiHand System to reach the market before the end of 2021.