More wearable neuromodulation device news
Quell, a wearable neuromodulation device FDA cleared for muscle and chronic pain is investigating its use for relief of Long Covid symptoms. Quell uses transcutaneous electrical stimulation to modulate nerves rather than PEMF but both methods achieve results via neuromodulation.
Pilot Trial Data Shows Neurostimulation Could Quell Long-COVID Pain
Orthopedic Design and Technology 12/12/2023
NeuroMetrix, maker of Quell wearable neuromodulation tech for chronic pain, recently presented data from a clinical trial of Quell for patients with post-acute COVID-19 syndrome (PACS), also known as “Long COVID”.
The presentation was made at the National Science Foundation (NSF) funded Center to Stream Healthcare In Place (C2SHIP) annual meeting in Washington D.C.
The study enrolled 30 subjects with persistent pain, fatigue, weakness, or poor gait after COVID-19 infection. They were randomized to a high- or low-dose Quell device for four weeks, using their device for at least three hours of nerve stimulation every day. Primary outcomes measures were baseline to four-week changes pain and fatigue, and secondary included objective gait assessments.
The trial met the BPI primary endpoint, with the pain interference subscale showing a greater decrease in the high-dose arm compared to low-dose (p = 0.01, Cohen's d effect size = 1.1). In the 60% of subjects who met ACR criteria for fibromyalgia, the MAF (Multidimensional Assessment of Fatigue) exhibited decrease in fatigue for the high-dose arm (p < 0.01) but not low (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 NeuroMetrix CEO Shai N. Gozani, MD. "This pilot trial suggests that Quell may alleviate fibromyalgia-like pain and other symptoms of Long Covid. We are conducting a regulatory review to determine if the data supports an expansion of the Quell fibromyalgia label. We appreciated the opportunity to work with Professor Bijan Najafi and his colleagues at the Baylor College of Medicine in this investigation. This project is a demonstration of the mission of C2SHIP to address some of the most difficult healthcare challenges facing the country.”
Quell, a wearable neuromodulation device FDA cleared for muscle and chronic pain is investigating its use for relief of Long Covid symptoms. Quell uses transcutaneous electrical stimulation to modulate nerves rather than PEMF but both methods achieve results via neuromodulation.
Pilot Trial Data Shows Neurostimulation Could Quell Long-COVID Pain
Orthopedic Design and Technology 12/12/2023
NeuroMetrix, maker of Quell wearable neuromodulation tech for chronic pain, recently presented data from a clinical trial of Quell for patients with post-acute COVID-19 syndrome (PACS), also known as “Long COVID”.
The presentation was made at the National Science Foundation (NSF) funded Center to Stream Healthcare In Place (C2SHIP) annual meeting in Washington D.C.
The study enrolled 30 subjects with persistent pain, fatigue, weakness, or poor gait after COVID-19 infection. They were randomized to a high- or low-dose Quell device for four weeks, using their device for at least three hours of nerve stimulation every day. Primary outcomes measures were baseline to four-week changes pain and fatigue, and secondary included objective gait assessments.
The trial met the BPI primary endpoint, with the pain interference subscale showing a greater decrease in the high-dose arm compared to low-dose (p = 0.01, Cohen's d effect size = 1.1). In the 60% of subjects who met ACR criteria for fibromyalgia, the MAF (Multidimensional Assessment of Fatigue) exhibited decrease in fatigue for the high-dose arm (p < 0.01) but not low (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 NeuroMetrix CEO Shai N. Gozani, MD. "This pilot trial suggests that Quell may alleviate fibromyalgia-like pain and other symptoms of Long Covid. We are conducting a regulatory review to determine if the data supports an expansion of the Quell fibromyalgia label. We appreciated the opportunity to work with Professor Bijan Najafi and his colleagues at the Baylor College of Medicine in this investigation. This project is a demonstration of the mission of C2SHIP to address some of the most difficult healthcare challenges facing the country.”
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