Fasikl’s NeuroAI™ Wristband Demonstrates Breakthrough Results in Pivotal TRANQUIL Study for Essential Tremor
Fasikl, a pioneering neuro-AI company at the forefront of integrating bioelectronic medicine with artificial intelligence, today announced that its landmark TRANQUIL study met its primary endpoint. The company’s Felix™ NeuroAI™ wristband demonstrated clear superiority over a sham device in reducing tremors and improving daily function in individuals with essential tremor (ET).
The Felix wristband delivered statistically and clinically meaningful improvements in users’ ability to perform everyday activities, significantly outperforming the control group.
“This wearable technology showed impressive benefits in tremor reduction, with both clinicians and patients more likely to report positive outcomes by the end of the study,” said Dr. Rajesh Pahwa, Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine and Director of the Movement Disorder Program at The University of Kansas Health System. Dr. Pahwa served as the principal investigator of the TRANQUIL study.
“The TRANQUIL study could mark a turning point in how we manage essential tremor—particularly given the limitations of current treatment options. While medications are commonly used, they often fail to deliver consistent results. And although deep brain stimulation and focused ultrasound offer effective relief, they require invasive procedures,” he added.
Key Study Outcomes:
- Over the 90-day study period, participants using Felix saw a mean 6.9-point reduction in modified Activities of Daily Living (mADL) scores, compared to just 2.7 points in the sham group (P < 0.0001).
- Nearly two-thirds of Felix users achieved at least a 20% reduction in mADL scores, versus only one-quarter in the control group.
- Efficacy was consistent across variables including age, gender, tremor severity, and concurrent use of ET medications.
- Secondary outcomes also favored Felix, with both clinicians and patients reporting greater symptom relief and improved quality of life.
- Importantly, no serious device-related adverse events were reported, underscoring the wristband’s strong safety profile.
The Felix NeuroAI™ Wristband is an innovative, non-invasive wearable designed to deliver personalized, all-day relief for people with essential tremor. Utilizing real-time feedback and AI-powered adaptive stimulation, Felix provides dynamic therapy tailored to the individual. The device seamlessly connects to Fasikl’s cloud-based AI platform, allowing for continuous optimization and learning over time.
“This is a historic milestone,” said Dr. Zhi Yang, CEO of Fasikl. “TRANQUIL is the first multicenter, double-blind, sham-controlled, non-surgical randomized controlled trial in essential tremor in over 20 years to meet its primary endpoint. Felix represents a paradigm shift in the treatment of essential tremor—offering a non-invasive, personalized, and AI-driven therapeutic alternative. With its safety and efficacy now validated, Felix has the potential to transform care for ET patients and redefine the broader landscape of movement disorder treatments.”
About Essential Tremor (ET)
Essential tremor (ET) is the most common type of tremor disorder, affecting approximately 7 million people in the United States.¹ It causes involuntary, rhythmic shaking, most often in the hands, which can make everyday activities like drinking from a glass or tying shoelaces difficult.² Over time, ET can worsen and significantly impact a person’s quality of life.²
The TRANQUIL Study
The TRANQUIL study, a randomized, double-blind, sham-controlled clinical trial, enrolled 125 adults across 12 clinical sites in the U.S. and China. Participants were randomized 2:1 to receive either the Felix™ NeuroAI™ Wristband or a sham device and wore it during waking hours 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), a commonly used tremor assessment that combines 10 activities of daily living (ADLs) and 2 clinical assessments of tremor.3 The mADL has a maximum score of 52.
About Fasikl
Based in Minneapolis, Fasikl, Inc. is a pioneering neuro-AI company dedicated to developing advanced, AI-powered neural technologies. A 2019 spin-off from the University of Minnesota, Fasikl leverages its proprietary platform to capture neural signals directly from peripheral nerves, enabling intelligent, adaptive therapy. The company is on a mission to transform the treatment landscape for movement disorders, paralysis, and other neurological impairments through cutting-edge neuromodulation innovations. Fasikl’s portfolio, currently under FDA review, includes the Felix™ NeuroAI™ Wristband and the MindForce™ Nerve-Computer Interface.
