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nQ Medical and EvergreenHealth are looking for people with early-stage Parkinson’s disease to participate in a month-long study of a software tool – known as neuroQWERTY – to help track motor symptoms by monitoring how fingers interact with a computer keyboard.
The study, which is expected to begin in July, will enroll approximately 50 patients at EvergreenHealth’s Booth Gardner Parkinson’s Care Center in Washington state. Four in-person visits to this center, one for each week of the study, are required.
Eligible patients must have a diagnosis of Parkinson’s within the past 10 years. They must also be willing to install the tool on their personal computer and use that computer for at least 15 minutes a day on average for four weeks.
The data, collected through home computer use between doctor visits, should better inform care plans for symptom management.
The results of this trial will also help support a request for regulatory clearance for use of the tool, nQ Medical CEO Richie Bavasso said in an email response to questions.
Those interested in participating are asked to contact the EvergreenHealth research team at 425.899.5385. Compensation will be paid, a press release said.
“This study is extremely important for the PD [Parkinson’s disease] community. Having more comprehensive, objective, long-term data that tells the full story of a patient’s symptoms over time means we can make even more informed decisions about the next steps in their care plan for managing symptoms. symptoms of PD,” said Rich Bavasso, Founder. and CEO of nQ Medical.
Parkinson’s disease begins subtly and its early stages provide the best opportunity for intervention. However, motor symptoms like tremors and stiffness are usually mild and can go unnoticed, posing a challenge for doctors.
A motor exam helps doctors identify and characterize these motor symptoms, but provides a snapshot of disease activity. To collect objective data between doctor visits, the researchers developed a software tool – neuroQWERTY – that uses typing patterns as a digital biomarker of motor symptoms.
The tool, compatible with Apple and Windows computers, measures the speed at which a person types on a keyboard and the pressure applied to each key.
Then, using machine learning, a branch of artificial intelligence that uses data to mimic the way humans learn, the tool looks for patterns in the way the person types.
The data generated will be compared to commonly used scales for Parkinson’s disease.
“This is an exciting opportunity to help make a difference in how…symptoms are monitored and managed. We know that every day can bring a new or different challenge to those living with PD,” said Pinky Agarwal, MD, neurologist at Booth Gardner Parkinson’s Care Center. “Effective management of the symptoms of this condition is very important and that starts with having the ability to accurately understand each patient’s symptoms between visits.”
The U.S. Food and Drug Administration (FDA) last year gave breakthrough device designation to the neuroQWERTY, which was developed at the Massachusetts Institute of Technology and funded in part by the Michael J. Fox Foundation.
nQ, in turn, was founded in 2016 “to move the technology from the academic setting to the commercial setting by upgrading the software to be ‘market ready’ for use by clinicians and patients; [and] pursue validation through clinical trials (like Evergreen),” Bavasso said.
Two clinical trials have been designed to evaluate the tool in patients with Parkinson’s disease.
In one study (NCT02522065), neuroQWERTY was reported to distinguish people with early-stage Parkinson’s disease from healthy people by analyzing home typing patterns, and did so in a comparable way tests performed in a clinic.
The other trial (NCT04101968), currently underway, uses neuroQWERTY as a diagnostic test to link the relationship between mutations in gamma-aminobutyric acid (GABA) – known to increase the risk of developing Parkinson’s disease – and early motor symptoms in people with these mutations, and with and without the disease.