Fasikl has reported breakthrough data showing its Felix NeuroAI wristband could offer a promising new non-invasive treatment for individuals with essential tremor.
Using artificial intelligence (AI), the Minneapolis-based company’s investigational wearable wristband, Felix NeuroAI, continuously adapts stimulation based on real-time feedback to provide patients with personalised therapy for essential tremor.
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The TRANQUIL study enrolled 125 adults at 12 clinical sites in the US and China, with participants randomised 2:1 to receive either the Felix NeuroAI wristband or a sham device for 90 days. The study’s primary endpoint was change in the modified Activities of Daily Living (mADL) score from the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS).
In the multicentre, double-blind, sham-controlled trial, patients who wore the device over a 90-day period experienced a clinically significant improvement in essential tremor treatment, meeting the trial’s primary endpoint with a mean reduction of 6.9 points on the mADL scale versus 2.7 points in the sham control group.
The device’s efficacy benefits were consistent across age, gender, tremor severity, and essential tremor medication use, with patients in the treatment group reporting greater symptom improvement and more substantial quality of life scores versus the control group. No serious device-related adverse events were reported.
The company presented the trial results at the 2025 American Academy of Neurology (AAN) Meeting, taking place in San Diego between 5-9 April.
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By GlobalDataDr. Rajesh Pahwa, Laverne and Joyce Rider professor of neurology at the University of Kansas School of Medicine, Director of the Movement Disorder Program at The University of Kansas Health System, and the principal investigator on the TRANQUIL study, said: “The TRANQUIL study represents what could be a shift in how we approach essential tremor treatment, a condition for which new options are sorely needed.
“Although oral medications are often used to treat essential tremor, they can be frequently unsatisfactory, and while deep brain stimulation and focused ultrasound are effective, they require surgical intervention.”
Essential tremor is characterised by involuntary rhythmic contractions and relaxations of certain muscle groups in one or more body parts of the body. While similar symptoms present in Parkinson’s disease patients, essential tremor is a distinct condition.
Around seven million individuals are living with essential tremor in the US. Several devices for treating the condition have been cleared by the US Food and Drug Administration (FDA), including Insightec’s Exablate Neuro platform that uses focused ultrasound waves to precisely target and ablate tissue deep within the brain, and Cala’s wrist-worn device that individualises the delivery of stimulation via transcutaneous afferent patterned stimulation (TAPS) by sensing each patient’s unique tremor signature.
