Transcutaneous Peripheral Nerve Stimulation Wristband Improves Clinical Outcomes for People with Essential Tremor

The Felix NeuroAI Wristband (Fasikl, Bloomington, MN), a transcutaneous peripheral nerve stimulation (TPNS) device worn on the wrist, significantly improved activities of daily living (ADLs) in people with essential tremor (ET) over 90 days in a pivotal study presented at the American Academy of Neurology (AAN) 2025 Annual Meeting. The device uses artificial intelligence software incorporating patient movement and surface neural recordings to deliver tailored and dynamic electrical stimulation to the ulnar, median, and radial nerves. Results of the multicenter, sham-controlled TRANQUIL clinical trial (NCT06235190) conducted in China and the United States demonstrated that Felix not only reduced tremor-related disability but also enhanced participant-reported quality of life (QoL) and was well tolerated.

TRANQUIL was a prospective, randomized, double-blind study conducted across 12 centers in the United States and China including a total of 121 participants with a clinical diagnosis of ET who were randomized 2:1 to receive Felix or sham treatment for home use over a period of 3 months. The primary end point was change from baseline in Tremor Research Group Essential Tremor Rating Scale (TETRAS) modified ADL (mADL) score.

• At 90 days, the primary end point was met: mADL score was improved by 6.9±6.0 points in the Felix group vs 2.7±4.1 in the sham treatment group (P<.0001).
• Treatment effect separation began at day 14.
• At 90 days, 69.4% of Felix users were rated as improved on the Clinical Global Impressions of Improvement (CGI-I) scale vs 44.4% of sham users (P=.02).
• Felix use was also associated with improvements in quality of life (QoL) and psychosocial scores, significantly outperforming sham.
• The most common device-related adverse event (AE) was mild skin irritation, occurring in 34.9% of Felix users and 7% of sham users and leading to 2 discontinuations.
• There were no serious device-related adverse events.

Source: Ondo W, Lv W, Zhu X, et al. TRANQUIL: pivotal study of the Felix NeuroAI Wristband in patients with essential tremor. Presented at: American Academy of Neurology Annual Meeting; April 5–9, 2025; San Diego, CA.