Neuros Medical announced that three-month results from a study demonstrating treatment with the company’s direct electrical nerve stimulation system will be published in the Journal of Pain Research. The study was the largest prospective, double-blinded, randomized study ever conducted for treatment of chronic postamputation pain. The 12-month results will be published later this year.
The QUEST Study was a multicenter, double-blinded, randomized, active-sham controlled pivotal study designed to assess the efficacy and safety of the Altius direct electrical nerve stimulation system in patients with chronic postamputation pain. The Investigational Device Exemption study enrolled 180 patients with a unilateral lower-limb amputations across 35 sites in the United States.
Patients were randomized 1:1 to active treatment or active sham groups with a single arm crossover to active treatment at three months and follow-up to twelve months. The primary efficacy endpoint was at least a 50 percent pain reduction in at least 50 percent of treatment sessions 30 minutes after initiating treatment. Secondary efficacy endpoints included at least a 50 percent pain reduction in at least 50 percent of treatment sessions after 120 minutes, change in opioid medication use, and improvement in quality of life. The primary safety endpoint was incidence of all serious adverse events.
Results indicated that primary efficacy and safety endpoints were met, demonstrating superiority of the treatment over active-sham control, the company said. The patients receiving the Altius treatment also experienced the following benefits compared to control patients:
- Highly statistically significant reduction in acute pain at 30 minutes after initiating treatment that increased significantly at 120 minutes
- 32 percent reduction in daily average pain scores, indicating a lasting effect of the treatment on the participants’ pain profiles
- 56 percent decrease in opioid use
- 39 percent improvement in quality of life
Highlights from the results were presented at the 16th World Congress of the International Neuromodulation Society earlier this month by Leonardo Kapural, MD, PhD, professor of anesthesiology at Florida Atlantic University, partner at Carolinas Pain Institute, and the study’s principal investigator.
“We have never seen a study of this magnitude and rigor in this patient population,” said Kapural. “The data demonstrated clear and lasting benefit of treatment for pain reduction and functional outcomes at three months, creating great optimism for the long-term study results. These findings represent a significant advancement for an at-risk and underserved patient population in desperate need of reliable and effective treatment.”
