NeuroMetrix, Inc. noted publication of an abstract describing partial results from a NIH-funded, multi-site randomized controlled trial of Quell titled "Wireless transcutaneous electric nerve stimulation (TENS) for chemotherapy-induced peripheral neuropathy (CIPN): A proof-of-concept, placebo-controlled, randomized clinical trial (RCT). The abstract will be published at the 2023 American Society of Clinical Oncology (ASCO) annual meeting to take place June 2-6 in Chicago, IL. The principal investigator is Dr. Jennifer Gewandter of the University of Rochester School of Medicine and Dentistry.

The trial leveraged the National Cancer Institute (NCI) Community Oncology Research Program (NCORP). The study was a phase II, multi-site, double blinded, randomized, sham-controlled trial. A total of 142 subjects with CIPN were randomized to an active or sham Quell device for 6-we weeks.

The study authors concluded "A RCT of an app-controlled, wireless TENS device for chronic CIPN with excellent adherence and retention rates is feasible in NCORP. Preliminary efficacy evidence suggests that TENS [Quell] is promising for pain and cramping from CIPN . A confirmatory RCT of TENS for painful CIPN is highly warranted." The use of Quell for chemotherapy induced peripheral neuropathy is investigational and has not been cleared or approved by the FDA.

The safety and effectiveness for this purpose have not been reviewed by the FDA. About 650,000 cancer patients receive chemotherapy annually in the United States. CIPN is a disabling complication that occurs in many patients treated with common chemotherapeutic drugs such as vincristine, paclitaxel and cisplatin.

A recently published systematic analysis reported that CIPN prevalence was 68% the first month after chemotherapy and 30% six-months after chemotherapy. CIPN symptoms include burning/shooting pain, tingling, cramping, and numbness in the hands and feet. CIPN is also associated with impaired balance, walking, and sleep, decreased quality of life, and increased risk of falls.

CIPN is difficult to treat with few treatment options, and those that are used have limited effectiveness and may cause serious side effects.