NeuroMetrix, Inc. noted publication of results from a NIH-funded clinical trial of Quell titled Wireless transcutaneous electric nerve stimulation (TENS) for chronic chemotherapy-induced peripheral neuropathy (CIPN): a proof-of-concept randomized clinical trial. The paper has been electronically published in The Journal of Pain. The study was a phase 2, 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-weeks. Subjects in both arms wore their device for 5 hours each day. Only a small number of minor adverse events were reported, primarily mild skin irritation that self-resolved.

The trial met its pre-specified primary endpoint of a significant least-squares between-group difference of the EORTC-CIPN20 total score. The EORTC-CIPN20 is a validated patient questionnaire measuring CIPN related quality of life. Of greater clinical relevance, patients with moderate to severe CIPN symptoms of hot/burning pain, sharp/shooting pain or muscle cramping experienced about a 50% reduction in these symptoms for active treatment compared to about 30% for sham treatment.

The study authors concluded The study supports the preliminary efficacy of the TENS device for painful CIPN symptoms. As evidenced by its designation from the FDA as a breakthrough device for chronic CIPN, Quell has potential as a safe and effective treatment that can be administered at home. 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.