Felix NeuroAI Wristband Demonstrates Superiority Over Sham Device in TRANQUIL Study for Essential Tremor

Fasikl recently reported that its pivotal TRANQUIL study (NCT06235190) met its primary end point, with the company’s investigational wearable Felix NeuroAI wristband demonstrating superiority over a sham device in reducing essential tremor (ET) and improving users' ability to perform daily activities.^1,2 The company noted that its AI-powered Felix wristband aims to offer noninvasive, personalized all-day relief for ET by continuously adapting therapy in real time through a connected cloud platform.

In the TRANQUIL trial, results showed a statistically and clinically significant benefit in tremor reduction for individuals using the Felix wristband compared with those using a sham device. After 90 days of use, participants in the Felix group experienced a mean reduction of 6.9 points in modified Activities of Daily Living (mADL) scores, compared with a 2.7-point reduction in the sham group (P <.0001). Nearly two-thirds of the Felix users achieved at least a 20% reduction in mADL scores, compared with just one-quarter in the sham group. Efficacy benefits were also observed across demographics including age, gender, tremor severity, and medication use.

“This wearable technology delivered significant improvement in tremor, with both clinicians and patients more likely to report benefit by the end of the study,” principal investigator Rajesh Pahwa, MD, director of the Movement Disorder Program at The University of Kansas Health System, said in a statement.¹ “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.”

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TRANQUIL was a randomized, double-blind, sham-controlled trial enrolling 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 the devices during waking hours for a period of 90 days. The study’s primary end point was change in the mADL score from the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS), which combines 10 daily living activities and 2 clinical tremor assessments, with a maximum score of 52.

Presented at the 2025 American Academy of Neurology (AAN) Annual Meeting, held April 5-9, in San Diego, California, researchers reported that secondary outcomes supported the primary findings, with both patients and clinicians reporting greater symptom improvement in the Felix group. Quality of life scores also improved more substantially among Felix users. In addition, the study reported no serious device-related adverse events.

“The TRANQUIL study marks a breakthrough as the first multicenter, double-blind, sham-controlled, non-surgical randomized controlled trial in essential tremor to meet its primary endpoint in over two decades,” Zhi Yang, PhD, CEO of Fasikl, said in a statement.¹ “Felix is a transformative advancement in AI-powered therapeutics, offering a safe, non-invasive, and personalized treatment option for ET patients and their physicians. With the efficacy and safety of Felix now validated and presented, we believe this represents a pivotal moment in the treatment of essential tremor and the broader landscape of movement disorders.”

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REFERENCES
1. Fasikl Announces Breakthrough Pivotal Data Demonstrating Superiority of Felix NeuroAI Wristband over Sham Device for Essential Tremor. News Release. Fasikl. Published April 8, 2025. Accessed April 10, 2025. https://www.fasikl.com/fasikl-announces-breakthrough-pivotal-data-demonstrating-superiority-of-felix-neuroai-wristband-over-sham-device-for-essential-tremor/
2. Fasikl to Present Late-breaking Results From the Pivotal TRANQUIL Study of the Felix NeuroAI Wristband at the 2025 American Academy of Neurology Annual Meeting. News Release. Fasikl. Published April 2, 2025. Accessed April 10, 2025. https://www.fasikl.com/fasikl-to-present-late-breaking-results-from-the-pivotal-tranquil-study/