Results from the TRANQUIL study demonstrated that participants using the Felix wristband experienced a significant mean reduction of 6.9 points in modified Activities of Daily Living (mADL) scores, compared to just 2.7 points in the sham group.

Both clinicians and patients reported notable improvements in symptoms and quality of life for those using the Felix device, with no serious device-related adverse events recorded, reinforcing its safety profile.

The findings from the TRANQUIL study were presented at the 2025 American Academy of Neurology Meeting in San Diego, highlighting the significance of this breakthrough in essential tremor treatment.

Fasikl, based in Minneapolis, is focused on revolutionizing treatment for movement disorders through innovative neuro-AI technologies, with the Felix wristband and other devices currently under FDA review.

Fasikl's Felix NeuroAI wristband has emerged as a promising non-invasive treatment for essential tremor (ET), leveraging AI to deliver personalized therapy.

The TRANQUIL study, a landmark trial involving 125 adults across the U.S. and China, is the first multicenter, double-blind, sham-controlled, non-surgical randomized trial in ET to successfully meet its primary endpoint in over two decades.

The study confirmed that no serious adverse events were associated with the Felix wristband, although mild skin irritation was noted as a common issue among participants.

The potential impact of the Felix NeuroAI wristband could significantly enhance the daily lives of individuals with ET, enabling them to engage in activities that were previously challenging.

Currently under review by the US Food and Drug Administration, the Felix wristband is designed to complement existing tremor medications like propranolol and primidone.

Dr. Rajesh Pahwa, the principal investigator, emphasized the urgent need for new treatment options for ET, as existing medications often fall short and surgical options may not be suitable for all patients.

Essential tremor affects approximately seven million people in the United States, characterized by involuntary shaking that can severely hinder daily activities.

Experts believe that AI-driven neuromodulation represents a significant advancement in personalized treatment, allowing for real-time adjustments tailored to individual patient needs.