Felix NeuroAI wristband improves essential tremor outcomes

Key takeaways:

• An AI-powered wristband was more effective than a sham device in improving essential tremor.
• It could be used as an alternative for patients who have an inadequate response or cannot tolerate oral drugs.

SAN DIEGO — A peripheral nerve stimulator powered by AI and worn as a wristband improved essential tremor symptoms and patients’ ability to perform daily activities compared with a sham device, data from the TRANQUIL trial show.

The study was highlighted during AAN’s Top Science Press Conference. It was one of three abstracts that Paul M. George, MD, PhD, FAAN, chair of the AAN Science Committee, selected for demonstrating “increasing brain resilience through scientific discoveries.”

“The ability to tap into our body’s own electrical signaling offers exciting new avenues to modify disease,” he said.

Oral treatments currently used for essential tremor are “often unsatisfactory,” according to Rajesh Pahwa, MD, FAAN, Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine, director of the Movement Disorder Program at the University of Kansas Health System and the principal investigator for TRANQUIL.

Researchers believe that the pathophysiology of tremor involves the ventral intermediate nucleus of the thalamus (VIM). Deep brain stimulation and focused ultrasound have been shown to reduce tremor by interrupting activity in the VIM, Pahwa said during the press conference. However, they require surgical interventions.

The Felix NeuroAI wristband (Fasikl Inc.) was developed as a noninvasive alternative that “uses a cloud-based AI algorithm to monitor tremor and adjust the stimulation in real time based on patients’ activity and predictive analytics,” Pahwa said.

“It is directed towards all three major nerves in the forearm and it is designed to be worn all day long,” he added.

Pahwa and colleagues tested the Felix NeuroAI wristband in the prospective, randomized, sham-controlled, double-blinded TRANQUIL trial. They randomly assigned 125 patients across 12 centers in the United States and China in a 2:1 ratio to wear Felix NeuroAI or a sham device at home for 90 days. The primary endpoint of the study was the change in TETRAS modified ADL (mADL) score, which assesses modified activities of daily living, Pahwa said.

About 78% of patients completed the study. From baseline to day 90, patients who used the Felix NeuroAI wristband had a greater reduction in mADL scores than those who used the sham device (6.9 vs. 2.7), according to Pahwa and colleagues. They were also more likely to have better Clinical Global Impressions of Improvement (69.4% vs. 44.4%) and Quality of Life in Essential Tremor Questionnaire scores.

“The most common adverse related events were mild skin irritation, which often did not require any treatment,” Pahwa said. “There were no serious adverse effects. Thus, this AI-driven wearable device was safe for use during the day and effective in reducing the symptoms of essential tremor.”

When asked whether the wristband might reduce the need for pharmacological therapies, Pahwa said it will more likely be used as a second-line option for patients who have an inadequate response or cannot tolerate oral medications.

Reference:

• Pahwa R, et al. TRANQUIL: Pivotal study of the Felix NeuroAI Wristband in patients with essential tremor. Presented at: AAN Annual Meeting; April 5-9, 2025; San Diego.