NeuroMetrix reports results from pilot trial of Quell in post-acute covid-19

NeuroMetrix reported the recent presentation of data from a clinical trial of Quell wearable neuromodulation technology in patients with post-acute COVID-19 syndrome, commonly called Long COVID. The presentation was made at the National Science Foundation funded Center to Stream Healthcare In Place annual meeting in Washington DC. The trial was conducted at the Baylor College of Medicine in collaboration with C2SHIP. The principal investigator was Dr. Bijan Najafi, Professor of Surgery, and clinical director at the Division of Vascular Surgery and Endovascular Therapy, Baylor College of Medicine. The Quell PACS study was a subject and investigator blinded, randomized, sham-controlled trial. Twenty-five subjects completed the study. The trial met the BPI primary endpoint, with the pain interference subscale exhibiting a greater decrease in the active arm compared to the sham arm. In the 60% of subjects who met ACR criteria for fibromyalgia, the MAF showed a significant within-group decrease in fatigue for the active arm but not for sham. The active group also demonstrated significant within-group improvements in gait quality. “The impact of COVID-19 lingers long after the acute infection in many individuals, and may resemble a fibromyalgia-like syndrome. Unfortunately, like traditional fibromyalgia, the COVID-19 version is debilitating and difficult to treat,” said Shai Gozani, M.D., Ph.D., CEO of NeuroMetrix. “This pilot trial suggests that Quell may alleviate fibromyalgia-like pain and other symptoms of Long Covid. We are conducting a regulatory review to determine if the data supports an expansion of the Quell fibromyalgia label. We appreciated the opportunity to work with Professor Bijan Najafi and his colleagues at the Baylor College of Medicine in this investigation. This project is a demonstration of the mission of C2SHIP to address some of the most difficult healthcare challenges facing the country.”