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FDA Grants Breakthrough Device Designation for nQ Medical’s neuroQWERTY

nQ

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to nQ Medical’s neuroQUERTY software, which is designed to monitor brain health and Parkinson’s disease progression.

Breakthrough device status is given to medical devices that have the potential to be an effective treatment or diagnostic tool for life-threatening or irreversibly debilitating diseases. The status speeds the review and assessment process so the devices can reach the market faster.

“The breakthrough device designation reaffirms that the nQ’s brain monitoring solution enables better treatment of patients by providing more precise and timely feedback to clinicians,” Rahul Mahajan, MD, chief medical officer of nQ Medical, said in a press release.

The neuroQWERTY software measures how fast a person is typing on a smart device and how much pressure they apply to each key. An artificial intelligence method called machine learning can detect small changes in the typing movements, which it can associate with different diseases such as Parkinson’s. The software does not record the words that were typed, only the patterns associated with the typing action.

“Everyone has a unique typing and touchscreen signature. Research has revealed that the way we interact with computers and mobile devices can reveal with startling accuracy the presence of certain neuromotor, neurocognitive, and neurobehavioral disorders,” said R.A. Bavasso, co-founder and CEO of nQ Medical.

NeuroQWERTY can be used with any keyboard, tablet or smart phone. This allows for round-the-clock monitoring of disease progression and treatment effectiveness without going to the clinic. This is a significant improvement from the current standard of care where patients see movement disorder specialists only once or twice a year.

“Just live your life as you normally do with your chosen personal device and we can collect and feed back to you and your physician the status of your brain health,” Bavasso said.

The software could speed diagnosis of neurodegenerative diseases, which would lead to earlier intervention and better clinical outcomes. The effect of new and existing therapies also can be monitored more closely, allowing doctors to quickly understand which treatment works best for each patient.

The nQ platform was developed at the Massachusetts Institute of Technology and funded partly by the Michael J. Fox Foundation, with the goal of creating an artificial intelligence tool to diagnose and monitor disease progression and track therapeutic effectiveness.

Five studies using neuroQWERTY have been published and five clinical trials have assessed this technology so far.

One clinical trial (NCT02522065) evaluated the use of the neuroQWERTY approach in an uncontrolled at-home setting, by analyzing the baseline data collected from participants who were diagnosed less than five years ago and were about to initiate dopaminergic therapy.

The technology was able to distinguish Parkinson’s patients from healthy individuals through the analysis of at-home typing patterns, and had a comparable performance to that performed in the clinic.

Another trial (NCT04101968) is currently using neuroQWERTY as one of its diagnostic tests to link the relationship between gamma-aminobutyric acid (GABA) mutations — known to increase the risk of developing Parkinson’s— and Parkinson’s disease.

The trial may help researchers understand the changes that take place in the brain of people with GBA-related Parkinson’s disease, especially during the early stages of the disease.

That study is still recruiting participants. More information can be found here.

More trials are planned in mild cognitive impairment (MCI), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and concussion (mTBI, or mild traumatic brain injury).

“The FDA’s recognition of enabling novel and effective digital therapies that demonstrate clinical evidence benefits helps the thousands of sufferers of Parkinson’s disease,” Mahajan said.

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PKG Wristwatch Device May Improve Clinical Decision-Making in Parkinson’s, Study Shows

PKG wearable monitoring device

A wrist-worn medical device — called the Personal KinetiGraph or PKG — that reminds people with Parkinson’s disease to take their medication, and records their movements to provide physicians with objective measurements of motor symptoms, showed great promise as a tool to improve clinical decision-making, a study found.

When worn for six days before a routine care visit, the device reported disease-related motor symptoms, like dyskinesiainvoluntary muscle movement — and bradykinesia, or the progressive slowness of movement over time, even when patients did not report such symptoms.

Overall, the device provided information for better treatment plans, allowed doctors to assess the efficacy of treatments, and improved doctor-patient communication.

The findings were reported in “PKG Movement Recording System Use Shows Promise in Routine Clinical Care of Patients With Parkinson’s Disease,” a study published in the journal Frontiers in Neurology.

The focus of Parkinson’s disease treatment is the relief, through medication, of symptoms like slow movements, rigidity, and tremor. However, such treatment regimens rely on patient self-reported symptoms, which often can be unreliable, even with validated assessments such as the Unified Parkinson’s Disease Rating Scale (UPDRS).

In addition, patients tend to do better during their appointments and clinical examination than at home.

The lack of objective data complicates treatment recommendations.

To overcome these problems, Global Kinetics Corporation (GKC) developed PKG, a watch-like device that objectively records movements and reminds patients to take their medication. The device was cleared for use by the U.S. Food and Drug Administration in September 2016. It weighs 35 grams, and is programmed and dispensed by clinical staff and worn by the patient for 6–10 full days.

The PGK uses accelerometers to monitor movement and a proprietary mathematical algorithm to convert the raw movement data into a PKG report — a graphical illustration of the patient’s movement that the clinician can analyze. That report provides “scores representative of dyskinesia and bradykinesia, compared to controls, throughout the day and from day to day,” the device’s website says.

To evaluate the clinical utility of the PKG, physicians at the University of California, Irvine (UCI) and University of California, Los Angeles (UCLA) now conducted a single-arm, open-label, observational study. The study included 63 people with Parkinson’s, ages between 46 and 83 years, who were responsive to dopaminergic therapy. In total, the patients had 85 routine care visits.

The main goal was to determine how often symptoms reported by patients disagreed with those in the PKG report. Secondary measures included the number of times the PKG report had findings that were treatable, how often doctors changed treatment based on the PKG report and how the report impacted patient care. Patients and caregivers’ satisfaction with the device also was measured.

The study’s participants wore the PKG for six continuous days before their appointments. Physicians then discussed symptoms with their patients and conducted a motor examination prior to uploading and reviewing the PKG report.

The team found that the PKG report demonstrated the presence of symptoms not reported by patients in 35% of the visits. Among these symptoms, bradykinesia was the most common finding of the PKG not picked up by the patient (50% of cases), followed by dyskinesia (33%). In contrast, 24% of patients reported a symptom that did not appear in the PKG report.

Regarding treatable symptoms, the device identified those individuals who could benefit from increases in levodopa doses or other treatments, including 47% of those with bradykinesia and 44% of those with dyskinesia.

In total, the report provided insights used to change treatment plans in 79% of participants, improved dialogue with the patient in 59% of visits, improved the ability to measure treatment impact in 38% of visits, and improved motor assessment in 33% of visits.

When surveyed at the end of the study, 82% of the participants agreed or strongly agreed that the PKG was easy to learn, easy to use, enabled them to confirm medication administration, and performed as expected. These patients said they would use the device again. In 39% of responses, participants also reported a very valuable impact on their care.

A 75-year-old women included in the trial “had difficulty reporting when she was off [when levodova effects wear out] and when she was dyskinetic,” the researchers said. “The PKG identified off times in the [morning] and dyskinesias in the afternoon. Based on the PKG data her regimen of carbidopa/levodopa dose was adjusted and her symptoms markedly improved.”

The researchers noted that the study was limited by the small number of patients. However, they said the results showed the usefulness of the new medical device.

“The PKG system provided clinical utility through improved characterization of motor manifestations of Parkinson’s disease, both the type and timing. This served to improve physician-patient dialogue and provide insight to clinicians and patients to inform treatment impact and decisions,” the team concluded.

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PKG Wearable Device Objectively Detects Motor Fluctuations, Dyskinesia, Study Shows

PKG motor fluctuations

A wearable motion-tracking device called Personal KinetiGraph (PKG) objectively and effectively assesses Parkinson’s-related motor fluctuations, researchers report.

The study, “The role of Personal KinetiGraphTM fluctuator score in quantifying the progression of motor fluctuations in Parkinson’s disease,” was published in Functional Neurology.

The PKG system, developed by Global Kinetics Corporation, is a wrist-worn movement recording device. It collects data on a person’s motor symptoms, including tremors, slowness of movement (bradykinesia), and abnormal involuntary movements (dyskinesia).

The technology also assesses patients’ motor fluctuations, immobility, and daytime somnolence, or sleepiness. Clinicians also can use it to help study an individual’s likelihood for developing impulsive behaviors, and to collect information on medication compliance.

The device has been cleared by the U.S. Food and Drug Administration, and holds CE certification, meaning it meets EU safety, health, and environmental protection requirements.

Previous studies have shown that PKG is able to distinguish between patients with and without motor fluctuations. Now, investigators at the Cedar-Sinai Medical Center in Los Angeles set up to determine whether the cut-offs of PKG motor fluctuation scores could define the progression of Parkinson’s fluctuation stages.

A total 54 Parkinson’s patients — 37 men and 17 women, mean age of 68 years — used the PKG device for 6 days. The participants then were asked to complete a 2-day standardized motor diary, essentially a journal in which the individuals would self-report and record their motor symptoms.

By applying clinically validated scales and questionnaires, researchers were able to categorize the participants into four groups: non-fluctuators (14 people), or patients without motor fluctuations; early (15 people); moderate (15 people); and troublesome fluctuators (10 people), or individuals with motor fluctuations due to a decline in the usual benefit of levodopa therapy.

Of the 54 individuals who completed the PKG trial, only 39 completed and delivered valid motor diaries. Compliance with the motor diary improved with decreasing severity of motor fluctuations — meaning that patients with less severe fluctuations were more likely to complete the diary.

PKG data revealed the device’s fluctuation scores significantly differentiated early fluctuators and troublesome fluctuators, as well as dyskinetic and non-dyskinetic patients.

Meanwhile, patient-reported motor diaries could not distinguish the four study groups based on the average “off” time, the researchers said.

Dopaminergic medications enable Parkinson’s motor symptom control — meaning that treatment temporarily stops the symptoms. However, as the disease progresses, patients typically need to gradually increase the treatment dose to get the maximum benefit. Even after that, however, they may still experience the reappearance or worsening of symptoms — known as “off periods” — due to the diminishing effects of the therapy.

Average time with dyskinesia, or abnormal involuntary movements, distinguished the non-fluctuators and moderate fluctuators. Importantly, the PKG system identified high dyskinesia scores in patients who denied having it.

“Motor fluctuations, including ‘wearing-off’ and dyskinesia, are associated with increased disease severity and disability, and PD [Parkinson’s disease] patients experience decreased quality of life as their response to medical therapy becomes less predictable,” Echo E. Tan, MD, neurologist at Cedar-Sinai Medical Center and the study’s lead author, said in a press release.

“Effectively managing motor fluctuations is complicated by the lack of objective assessment tools, leading patients and physicians to rely on direct observation in the clinic or patient reports, which may be unrevealing, incomplete and unreliable,” Tan added.

The researchers noted that “wearable devices transcend language barriers, cognitive barriers, as well as time constraints in the clinic.” That makes this wearable device a useful tool to objectively measure motor fluctuations in Parkinson’s disease.

“The results of our study demonstrate that the fluctuation score calculated by the PKG system provides objective quantification of motor fluctuations. This may help improve routine management of PD [Parkinson’s disease] patients and enable more objective assessments in clinical trials of PD [Parkinson’s disease] therapies,” Tan concluded.

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