(NIH.gov)
14 Apr. 2020. A mobile app providing speech therapy exercises at home for people recovering from a stroke received a breakthrough device designation from FDA. The Food and Drug Administration granted the breakthrough designation to The Learning Corp. in Newton, Massachusetts, developer of Constant Therapy apps that combine real-world evidence with artificial intelligence to aid in the recovery of people with neurological disorders.
Stroke occurs when blood flow to the brain is interrupted, cutting the oxygen needed by brain cells to function. The vast majority (85%) of strokes are caused by blood clots, while many other strokes are caused by blood vessel leakage in the brain. Recovery, often in rehabilitation clinics, can take months or years of continuous exercises. World Stroke Organization says one in four people worldwide will have a stroke in their lifetime, with nearly 14 million people suffering a stroke each year.
Many people who suffer a stroke encounter difficulties in speaking, a condition called aphasia affecting the ability to speak or comprehend speech. Aphasia can range from mild to severe, and include putting words together into sentences or the ability to read. In severe cases of aphasia, communication with patients is almost impossible.
The Learning Corp. develops apps to extend therapy for neurological conditions from the clinic to the home for stroke, as well as mild cognitive impairment and Alzheimer’s disease, which are now in clinical trials. The company is also developing therapy apps for traumatic brain injury, multiple sclerosis, Parkinson’s disease, major depressive disorder, and epilepsy. The Learning Corp.’s core technology, called NeuroPerformance Engine, collects real-world evidence from people with the conditions, then applies artificial intelligence algorithms to provide personalized exercises for users.
The company’s speech therapy app, code-named TLC-001, offers cognitive development, language, and speech exercises for people recovering from a stroke. The software is written to resemble exercises conducted one-on-one with a speech therapist, based on neuroscience research at Boston University. The programs run on smartphones and tablets, downloaded from The Learning Corp. web site.
Researchers from The Learning Corp. and Boston University compared results of treatments over four years with the company’s speech therapy app to clinic-based therapy among people with aphasia resulting from a stroke, in a journal article published last year. The findings show users of the mobile app achieve outcomes similar to individuals receiving therapy in a clinic, with in some cases the app users accomplishing their results in a shorter time. The ability of patients to perform exercises at home with the app more frequently than individuals going in for scheduled clinic visits, say the authors, helps achieve the faster results.
The Learning Corp. says in a statement released through BusinessWire that the speech therapy app is the first cognitive linguistics app to receive FDA’s breakthrough device designation. The breakthrough device status recognizes new devices that offer meaningful advantages over currently cleared technologies, addressing unmet medical needs, and where no other current alternatives exist. Breakthrough devices are given higher priority and more attention from FDA staff to reduce the time needed for review under the agency’s medical device pathways.
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