NeuroMetrix, Inc. reported the recent presentation of data from a clinical trial of Quell wearable neuromodulation technology in patients with post-acute COVID-19 syndrome (PACS), commonly called Long COVID. The presentation was made at the National Science Foundation (NSF) funded Center to Stream Healthcare In Place (C2SHIP) 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. According to the Centers for Disease Control and Prevention (CDC), about 10 million Americans have PACS. Subjects were randomized to an active (high dose) or sham (low dose) Quell device for 4-we weeks.

Subjects in both arms were instructed to use their device for at least 3-hours of nerve stimulation each day. The primary outcome measures were baseline to 4-week changes in pain (Brief Pain Inventory, BPI) and fatigue (Multidimensional Assessment of Fatigue, MAF). Secondary outcomes measures included objective assessments of gait.

Complete study details are available at clinicaltrials.gov (NCT05200858). Twenty-five subjects (12 active, 13 sham) 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 (p = 0.01,Cohen's d effect size = 1.1).

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 (p < 0.01) but not for sham (p = 0.19). The active group also demonstrated significant within-group improvements in gait quality. The use of Quell for post-acute COVID -19 syndrome is investigational and has not been cleared or approved by the FDA.

The safety and effectiveness for this purpose has not been reviewed by the FDA.