Fasikl, a trailblazing neuro-AI company redefining the intersection of advanced bioelectronic medicine and artificial intelligence (AI), today announced that patients with essential tremor (ET) who used the Felix NeuroAI™ Wristband saw clinically meaningful and sustained functional improvement over a full year, with greater improvement the longer they used it, according to new peer-reviewed data published in Movement Disorder Clinical Practice.1 Another recent article in the same publication established clinically meaningful change thresholds for two commonly used Essential Tremor Rating Assessment Scale (TETRAS)-based outcome measures in ET.2

ET is a neurological condition that typically worsens over time, causing involuntary shaking, most often in the hands. The FDA-cleared Felix NeuroAI™ Wristband from Fasikl is the first and only artificial intelligence (AI)-powered, non-invasive wearable designed to deliver all-day, personalized tremor relief for people with essential tremor (ET), without drugs or surgery. It stimulates nerves in the wrist to signal the brain to reduce tremors and restore motor control, using AI to adapt to each patient’s tremor profile.

Sustained and Progressive Functional Improvement Through One Year with a Favorable Safety Profile

The one-year open-label extension trial not only showed improvement in patient ET symptoms over the study period, the trial also demonstrated growing treatment effects from ongoing use, illustrating the potential for additional benefit with long-term use of the Felix NeuroAI™ Wristband. These data built on previous 90-day results showing that AI-managed transcutaneous peripheral nerve stimulation delivered by the device improved function in patients with ET.

The extension study assessed the impact over one year in two groups: those who used the wristband for an entire year and a sham group that switched to the wristband after 90 days. Researchers tracked daily functioning, clinician- and patient-rated improvement, quality of life, and safety over the full year, assessing outcomes based on a modified Activities of Daily Living (mADL) subscale of TETRAS.

Key outcomes included:

  • Daily functioning continued to improve well past the initial 90 days, climbing from 6.9 points at day 90 to 9.7 points at 1 year on the mADL scale.

  • Patients who started on the sham device saw similar mADL gains once they switched to Felix, improving 5.5 points in their first 90 days of active treatment.

  • Clinician- and patient-rated improvement, along with quality of life, continued improving in both groups from 90 days to 1 year.

  • Favorable safety and tolerability. Adverse events were generally mild, such as skin irritation that required topical or no treatment.

“The data also showed patients continued to improve beyond 90 days and did not plateau,” said Rajesh Pahwa, M.D., University of Kansas Medical Center Department of Neurology and co-author of the study. “This is an advancement for patients with essential tremor who want a safe, non-invasive, and personalized option.”

Establishing a Standard for Minimum Clinically Important Difference in Essential Tremor

Minimum clinically important difference (MCID) helps distinguish clinically meaningful benefit from statistically significant, but clinically trivial, change. Modified versions of TETRAS, including the mADL scale and the mADL11 scale, are frequently used as primary outcome measures in ET clinical trials, but MCIDs for these measures have not been established.

This study established estimated MCID thresholds of -6.2 points for mADL and -4.1 points for mADL11. By these standards, the Felix NeuroAI™ Wristband has been shown to produce clinically important improvements, even with as little as 90 days of use.

“As medicine continues to advance how we treat essential tremor, it’s important to have agreed-upon standards for measuring clinically meaningful improvement,” said William G. Ondo, M.D., of Houston Methodist Hospital and Weill Cornell Medical School and co-author of the study. “The MCIDs established in this research may aid interpretation of future clinical essential tremor trials.”

“Essential tremor affects nearly 7 million Americans – seven times more than Parkinson’s disease – yet effective treatment options remain limited,” said Zhi Yang, Ph.D., CEO of Fasikl. “These data show that a wearable, when empowered by AI, can deliver clinically meaningful functional improvements at a level traditionally associated with medications or surgical interventions. Felix is an intelligent, AI-driven therapy that adapts to each individual and improves care over time while integrating into daily life. We believe these findings point to the broader potential of AI therapeutics as a new treatment modality and a promising direction for the future of medicine.”

Involuntary shaking due to ET can make even routine tasks like holding a cup of coffee or tying a shoelace difficult.3 Traditional treatments fall short for many: medications may not work well or can cause side effects, while surgical procedures like deep brain stimulation are invasive and not suitable for everyone.4

The Felix NeuroAI™ Wristband is available by prescription through healthcare providers.

About the Felix NeuroAI™ Wristband

The FDA-cleared Felix NeuroAI™ Wristband from Fasikl is the first and only artificial intelligence (AI)-powered, non-invasive wearable designed to deliver all-day, personalized tremor relief for people with essential tremor (ET), without drugs or surgery. Using real-time AI, Felix stimulates peripheral nerves on the wrist to send therapeutic signals to the brain, reducing tremors and restoring motor control. Unlike traditional treatments, Felix continuously monitors and adapts to each user’s unique tremor profile, optimizing therapy over time through Fasikl’s secure cloud-based AI platform. The wristband’s intelligent, adaptive, and wearable design allows patients to experience effective symptom relief while maintaining comfort, safety, and freedom in daily life.

About Fasikl

Based in Minneapolis, Fasikl, Inc. is a pioneering neuro-AI company developing advanced artificial intelligence technologies to transform the treatment of neurological diseases. Founded in 2019 as a spin-off from the University of Minnesota, Fasikl has developed a proprietary platform that combines neural sensing, neuromodulation, and disease-specific AI models to create intelligent therapies that adapt to individual patients and improve treatment over time. Fasikl’s portfolio includes the FDA-cleared Felix NeuroAI™ Wristband and the investigational Fasikl-X™ Nerve-Computer Interface. To learn more, visit fasikl.com.

References:

  1. Isaacson, S.H., Hu, Y., Ondo, W.G., Lv, W., Zhu, X., Yuan, Y., Espay, A.J., Kreitzman, D., Kuo, S.-H., Brillman, S., Shill, H.A., Lyons, K.E., Yang, Z., Zhao, Q., Zhang, Z. and Pahwa, R. (2026), Efficacy and Safety of the Felix NeuroAI Wristband for Essential Tremor: Results of a One-year Open-label Extension Trial. Mov Disord Clin Pract. http://doi.org/10.1002/mdc3.70833.

  2. Ondo, W.G., Isaacson, S.H., Lv, W., Zhu, X., Hu, Y., Yuan, Y., Espay, A.J., Kuo, S.-H., Shill, H.A., Lyons, K.E., Yang, Z., Zhao, Q., Zhang, Z. and Pahwa, R. (2026), Minimal Clinically Important Difference in TETRAS Score for Essential Tremor. Mov Disord Clin Pract. https://doi.org/10.1002/mdc3.70807.

  3. Mayo Foundation for Medical Education and Research. (2025, March 15). Essential tremor. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/essential-tremor/symptoms-causes/syc-20350534.

  4. Diaz, N. L., & Louis, E. D. (2010). Survey of medication usage patterns among essential tremor patients: movement disorder specialists vs. general neurologists. Parkinsonism & related disorders, mju816(9), 604-607. https://doi.org/10.1016/j.parkreldis.2010.07.011.

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