Aclarion Begins Nociscan Clinical Trial

Aclarion Inc. has initiated a multi-center trial (CLUE) to quantify the impact of the company’s Nociscan decision support tool on surgical treatment plans. Specifically, the study will determine the frequency of treatment plan changes when physicians access proprietary Nociscan data.

CLUE results will provide insight into the real-world value of adding Nociscan to existing diagnostic evaluation methods for chronic low back pain treatment.
 
“Diagnosing the source of chronic low back pain is a significant challenge for clinicians and often results in the omission or inclusion of treatment on discs that do not correlate to improved clinical outcomes,” Aclarion Chief Strategy Officer Ryan Bond said. “Evidence points to a significant improvement in outcomes when Nociscan information is added to the treatment planning process. CLUE is specifically designed to quickly determine how influential Nociscan is in evaluating which discs a physician decides to treat.”
 
Another study—launched earlier this year (CLARITY)—aims to demonstrate better surgical outcomes when Nociscan data is included in the surgical decision-making process. CLARITY is a gold standard, multicenter, prospective randomized trial. CLUE is designed to provide near-term insights into the probability of success of CLARITY by quantifying the number of times (if at all) Nociscan data leads a surgeon to change the original treatment decision.
 
“CLUE represents an opportunity to study the use of Nociscan in an independent and scalable fashion.  Any physician with access to Nociscan can easily access this survey tool to build their own evidence and body of data to use when advocating for insurance coverage of Nociscan,” Aclarion CEO Brent Ness said. “The format for CLUE closely follows the evidence strategy demonstrated by HeartFlow, whose findings ultimately rewrote the patient pathway for assessing coronary artery disease. We remain committed to leading with evidence as we work to change the way data is used to improve outcomes in chronic low back pain, the highest cost diagnosis in healthcare worldwide.”

Through a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) data from an MRI machine for each lumbar disc under evaluation. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers  associated with disc pain. The biomarker data is entered into proprietary algorithms to indicate whether a disc may be a source of pain. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving physicians more clarity in optimizing treatment strategies.
 
Aclarion is a Broomfield, Colo.-based company that leverages magnetic resonance spectroscopy proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to optimize clinical treatments. The firm is first addressing the chronic low back pain market with Nociscan, the first, evidence-supported, SaaS platform to noninvasively help physicians distinguish between painful and nonpainful lumbar spinal discs.