Parkinson Disease Symptom Data Tool StrivePD Receives FDA Clearance

Author(s):

Through the StrivePD ecosystem and an Apple Watch, patients, including those who have been treated with Medtronics’ deep brain stimulation device, are able to track and log their symptoms.

Brian Pepin, MSEE

The FDA has granted 510(k) clearance to Rune Labs’ StrivePD software ecosystem, an application that collects data on symptoms of patients with Parkinson disease (PD) using an Apple Watch, with the intention of improving care management and clinical trial design.¹

Patients using the app can track and log their symptoms, thus enabling greater control of their disease. The clearance opens the door for thousands of patients already using the tool to participate in clinical trials that could have significant impacts on future therapeutics. Additionally, the hope is that StrivePD may help locate and facilitate patients with prodromal PD, the stage at which individuals do not fulfill the diagnostic criteria for PD but do exhibit signs and symptoms.

"As we have seen in oncology, the introduction of large quantities of real-world data has the power to transform drug development and fundamentally change disease prognosis. This clearance is a major step towards building a similar paradigm in neurology," Brian Pepin, MSEE, chief executive officer and founder, Rune Labs, said in a statement.¹ “With all of the data we will collect and the patients we will reach through this clearance, we will make sure the right participants enroll in trials, and help our pharma and medtech partners run more efficient trials with higher quality outcomes data, thereby enabling more therapies to come to market quickly to help those suffering from Parkinson's."

As part of an existing partnership with Medtronic, the StrivePD app will be utilized for clinicians interpreting data on patients who use Medtronic’s Percept PC Deep Brain Stimulation (DBS) device, which received FDA approval in June 2021.² The two companies announced the collaboration in November 2021, which uses Rune’s proprieatary software platform to integrate, analyze, and display data captured from the neurostimulator, along with data from the StrivePD application and other sources.

Rune’s software platform delivers data from Medtronic’s neurostimulation device to participating clinicians in a unique and objective way to support patient-specific treatment decisions. This includes the continuous monitoring of local field potentials a million times smaller than DBS stimulation pulses that can correlate with PD symptoms, as well as other additional sources, such as a patient wearable and patient-reported symptoms, and medication dosing.

Features of the SenSight system include a proximal end of lead inserted into an extension, laser-etched markers on the proximal end for identification of left and right leads with bilateral implants, and laser-etched insertion line on the lead body, which provides visual confirmation of complete insertion and thus providing confidence in the connection. Additionally, the SenSight extension comprises of a single set screw connection on a non-active contact to minimize steps and protect therapeutic delivery. A radiopaque marker is visible under computed tomography (CT), fluoroscopy, X-ray, and the O-arm Imaging System, for distinguishing with bilateral implants.²

"Being able to show my neurologist how my motor symptoms were fluctuating, thanks to StrivePD, was the impetus for me to get surgery for a deep brain stimulation device," Aura Oslapas, creator of the StrivePD mobile app and patient with PD, said in a statement.¹ "When people with Parkinson's are prescribed new medications, adjusting how much to take and when to take it until they find something that works can be a lengthy process. StrivePD helps people to track their symptoms and improvements, accelerating the time to an optimal medication schedule – and with today's clearance, more people will have access to this life-changing technology."

Oslapas has worked with Rune Labs on improving the user experience of the app since the company acquired it in 2019. Additionally, she recently joined their Patient Advisory Board as well. She added, “StrivePD on Apple Watch is the long-awaited union of quantitative and qualitative data that encourages better care and communication between patients and clinicians, while also empowering people with Parkinson's who are striving to live better every day."

REFERENCES
1. Rune labs secures FDA clearance for Parkinson’s disease monitoring through StrivePD ecosystem on Apple Watch. News release. Rune Labs. June 13, 2022. Accessed June 20, 2022. https://www.prnewswire.com/news-releases/rune-labs-secures-fda-clearance-for-parkinsons-disease-monitoring-through-strivepd-ecosystem-on-apple-watch-301566472.html
2. FDA Approves first-of-its-kind SenSight Directional Lead System for DBS Therapy. News release. Medtronic. June 7, 2021. Accessed June 11, 2021. https://newsroom.medtronic.com/news-releases/news-release-details/fda-approves-first-its-kind-sensighttm-directional-lead-system