Over 10 million Americans are estimated to be living with PACS. This condition is defined as persistent symptoms following an acute COVID-19 infection. It may affect over one-third of individuals who had COVID-19, even those whose initial disease was mild or asymptomatic. PACS is characterized by a constellation of symptoms that include fatigue, joint pain, muscle pain, memory and concentration issues, sleep problems, shortness of breath, cough, and heart rate abnormalities. Many of these symptoms are also characteristic of fibromyalgia. In a recently published study, 31% of individuals who experienced an acute COVID-19 infection met the
Quell is an advanced, non-invasive, neuromodulation technology that is covered by 22 U.S. utility patents and numerous international patents. It is the only wearable neuromodulator that is enabled by a proprietary microchip that provides precise, high-power nerve stimulation in a form factor the size of a credit card. The Quell device utilizes position and motion sensing to automatically adjust stimulation for an optimal patient experience both day and night. The device supports Bluetooth® low energy (BLE) to communicate with smartphone and smartwatch apps that help the patient personalize and control their treatment. The
The PACS study is a double blinded, randomized, sham-controlled trial (RCT). A total of 40 patients with persistent symptoms of pain, fatigue, weakness, or poor gait and balance following COVID-19 infection will be enrolled. The subjects will be randomized to an active or sham Quell device for 4-weeks. Subjects in both arms will be instructed to use their device for at least 3-hours of nerve stimulation each day. The primary outcome measures are baseline to 4-week changes in pain, sleep and fatigue. Secondary outcomes measures include patient global impression of change, quality of life and objective assessments of gait, lower extremity muscle function and sural nerve conduction using the DPNCheck® device. Complete study details are available at clinicaltrials.gov.
“This project will test the potential effectiveness of Quell, which is a practical neuromodulation wearable technology, shown to be effective to manage pain and lower extremities symptoms, for clinical management of patients with PACS," said
"The impact of COVID-19 appears to linger long after the acute infection, which may lead to a profound surge of chronic illness in the coming years. One of the likely manifestations will be an increase in a fibromyalgia-like syndrome. Unfortunately, like traditional fibromyalgia, the COVID-19 version is expected to be debilitating and difficult to treat," said
Note: The use of Quell for post-acute COVID-19 syndrome and fibromyalgia is investigational and neither indication has been cleared or approved by the FDA. The safety and effectiveness for these purposes have not been reviewed by the FDA.
SVP and Chief Financial Officer
Source: NeuroMetrix, Inc.