Aclarion Inc. announced the completion of the first Nociscan exams for patients enrolled in the LIFEHAB Trial in Norway. The randomized controlled trial is studying 202 patients with low back pain lasting more than one year and will compare outcomes between lumbar interbody fusion surgery and multidisciplinary rehabilitation.
Nociscan was selected for use in the study to evaluate how magnetic resonance spectroscopy (MRS) biomarkers can identify patient improvement following treatment. Patient enrollment in LIFEHAB began in the second quarter of 2024, and the initial enrolled patients began completing Nociscan exams in the last week of August. So far, six patients have completed their Nociscan exams.
“We are excited to see the LIFEHAB Trial progressing on schedule and look forward to the results of the study and to the role we expect Nociscan data to play in not only helping physicians determine which discs to treat but in potentially helping to predict which treatment option is optimal for a particular patient,” said Brent Ness, CEO of Broomfield-based Aclarion.
Aclarion is awaiting results from a completed trial in Rome where Nociscan technology was utilized to evaluate regenerative technologies, as well as the outcomes of two NIH studies focused on treating chronic low back pain with Nociscan. “We see Nociscan moving at an accelerated pace of adoption in the research market and look forward to announcing more partnerships as we continue to drive Nociscan to what we expect to be the gold standard for determining which discs to treat in research protocols on low back pain,” said Ryan Bond, chief strategy officer of Aclarion.
Aclarion believes the results of the LIFEHAB trial, together with other evidence, may be a significant step toward achieving successful reimbursement in a single-payer national health insurance system like Norway. The LIFEHAB trial is the latest customer-sponsored clinical study involving Nociscan, and the company anticipates announcing additional partnerships as the technology expands in the research market.