Based in San Diego, California, NeuraLace Medical is committed to creating innovative non-invasive chronic pain therapies. The company has developed Axon Therapy technology – an FDA 510(k)-cleared device for treating nerve pain. This groundbreaking magnetic pulse treatment initiates the body’s inherent mechanisms of reducing discomfort and offers a novel approach to countering suffering from chronic pain.
Tracking Participant-Centric Secondary Endpoints
The Axon device is FDA-approved to treat chronic post-surgical or post-traumatic neuropathic pain. To seek clearance for additional indications, NeuraLace sought to measure secondary endpoints and identify potential changes to participant quality of life.
“Our investigators understand that there is much more to pain than just the pain scale numbers,” said Joe Milkovits, Chief Operating Officer, NeuraLace. “Are participants moving around more? Do they feel better about their situations? Quality of life matters.”
NeuraLace experienced participant enrollment and compliance challenges early in their research. Initial designs and participant recruitment initiatives led to insufficient enrollment, jeopardizing the study. In the first year of recruitment, only 17 participants were successfully enrolled, with a goal of 80.
A Consultative Approach to Overcome Compliance Obstacles
To address the issues with participant ePRO compliance, NeuraLace needed to engage their patients in new ways. The team collaborated with Medrio to avoid using only email-based data exchanges and also include Medrio’s SMS-enabled ePRO feature, hoping that the ease of text messaging would help improve compliance.
Working with Medrio and their team, the holistic refinements NeuraLace made addressed the needs of study participants, and in just three months, enrollment more than doubled to 35 participants.
Regarding participant ePRO compliance, adding SMS reminders for ePRO collection allowed the initial study site to realize more than 90% compliance rates. These results have made texting imperative for future projects.
“The improvements in compliance we saw with our first site made it a no-brainer to use the text option for new sites,” said Milkovits. “Our two newest sites have only known the text option, and their ePRO compliance rates have stayed at 90% or better.” By making engagement more straightforward via text messaging, Medrio helped NeuraLace achieve data entry compliance.
With Medrio’s guidance and technology, NeuraLace was able to accelerate enrollment, improve participant retention and enable better participant compliance. Further, through Medrio’s EDC refinements and SMS-enabled ePRO, NeuraLace could give its sites the tools they need for more effective participant engagement.
