Neurolutions, a company with offices in Santa Cruz, CA and St. Louis, MO, won FDA de novo authorization to introduce its IpsiHand stroke rehab system in the United States. This is the first approval of a brain-computer interface technology for the rehabilitation of stroke patients, and it promises a faster and more complete recovery of hand function in many patients. The IpsiHand system takes advantage of the uninjured side of the brain to trigger the opening and closing of a robotic exoskeleton placed over the affected arm. The patient wears a brain-wave detecting EEG headset that interprets the relevant signals and sends them to the exoskeleton. The idea is based on the concept that “neurons that fire together wire together,” according to Neurolutions, and as the patient desires to move the hand, it actually does. This is performed repeatedly during multiple sessions, which occur at the clinic or independently at home. This repetitive reinforcement has shown in clinical studies to significantly improve therapy outcomes, including muscle re-education and increased range of motion, in patients long after (≥ 6 months) their stroke diagnosis. Here’s a bit more about the technology, according to its manufacturer: 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. Source
