According to the
The Quell PACS study was a subject and investigator blinded, randomized, sham-controlled trial. A total of 30 subjects with persistent symptoms of pain, fatigue, weakness, or poor gait and balance following COVID-19 infection were enrolled. Subjects were randomized to an active (high dose) or sham (low dose) Quell device for 4-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 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
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.
The mission of the Center to
About Quell Technology
Quell is an advanced, non-invasive, neuromodulation platform that is covered by 26 issued U.S. utility patents. It is the only wearable neuromodulator that is enabled by a proprietary microchip to provide precise, high-power nerve stimulation in a form factor the size of a credit card. Quell utilizes position and motion sensing to automatically adjust stimulation for an optimal user experience both day and night. The device supports Bluetooth® low energy (BLE) to communicate with mobile apps and the Quell Health Cloud. Quell is indicated to help reduce fibromyalgia symptoms in patients with high pain sensitivity and to reduce lower extremity chronic pain.
NeuroMetrix is a commercial stage healthcare company that develops and commercializes neurotechnology devices to address unmet needs in the chronic pain and diabetes markets. The Company's products are wearable or hand-held medical devices enabled by proprietary consumables and software solutions that include mobile apps, enterprise software and cloud-based systems. The Company has two commercial brands. Quell® is a wearable neuromodulation platform. DPNCheck® is a point-of-care screening test for peripheral neuropathy. For more information, visit www.neurometrix.com.
SVP and Chief Financial Officer
Source: NeuroMetrix, Inc.