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Abstract Details

TRANQUIL: Pivotal Study of the Felix NeuroAI Wristband in Patients with Essential Tremor
Movement Disorders
LS2 - Late-breaking Science 2 (6:09 PM-6:15 PM)
005

To evaluate the efficacy and safety of the FelixTM system in comparison to a sham device.

Essential tremor (ET), a common movement disorder, significantly impacts activities of daily living (ADLs). The FelixTM NeuroAITM Wristband is an artificial intelligence (AI)-driven transcutaneous peripheral nerve stimulation (TPNS) system for ET. Using a proprietary cloud-based AI model, Felix delivers tailored and dynamic electrical stimulation to the ulnar, median, and radial nerves throughout the day.

TRANQUIL was a prospective, randomized, sham-controlled, double-blinded, 12-center trial conducted in the US and China. Patients were randomized 2:1 to Felix or sham treatment at home for 90 days. The primary endpoint was change from baseline to 90 days in the TETRAS modified ADL (mADL) score. Secondary endpoints included changes in mADL in subgroups and at other timepoints, Clinical Global Impressions of Improvement (CGI-I), and Quality of Life in Essential Tremor Questionnaire (QUEST). Safety was also examined.

Of 125 patients randomized (50% female; tremor duration, 11.4±13.1 years; mean age, 64.9±13.1 years), 40.0% were taking at least one medication for tremor. There were no clinical or demographic differences between the arms. At 90 days, mADL was reduced by 6.9±6.0 (Felix) vs. 2.7±4.1 (sham) (P<0.0001; two-sample t-test). This result was consistent across key subgroups. Change separation in mADL started after 14 days. Improvement on the CGI-I was seen in 69.4% (Felix) and 44.4% (sham) of patients (P=0.02; chi-square test). Felix improved QUEST activity and psychosocial scores significantly more than sham treatment.

No serious device-related adverse events occurred. Mild skin irritation, the most common device-related adverse event, occurred in 34.9% of the Felix group (US: 20.9%, China 50%) and in 7% of the sham group, and led to 2 discontinuations.

Felix, the first full-day, AI-driven TPNS device, was safe and effective for the treatment of ET.
Authors/Disclosures
Rajesh Pahwa, MD, FAAN (University of Kansas Medical Center)
PRESENTER 		Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbott. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ACADIA. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Insightec. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jaaz. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fasikl. Dr. Pahwa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genetech. Dr. Pahwa has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Pahwa has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Photopharmics. The institution of Dr. Pahwa has received research support from Abbott. The institution of Dr. Pahwa has received research support from Abbvie. The institution of Dr. Pahwa has received research support from Biogen. The institution of Dr. Pahwa has received research support from Parkinson Foundation. The institution of Dr. Pahwa has received research support from Roche. The institution of Dr. Pahwa has received research support from Sage. The institution of Dr. Pahwa has received research support from Sun Pharma. The institution of Dr. Pahwa has received research support from Theravance. The institution of Dr. Pahwa has received research support from Neuroderm. The institution of Dr. Pahwa has received research support from Ask Bio. The institution of Dr. Pahwa has received research support from Blue Rock. The institution of Dr. Pahwa has received research support from Cerevance. The institution of Dr. Pahwa has received research support from Fasikl. The institution of Dr. Pahwa has received research support from Scion. The institution of Dr. Pahwa has received research support from UCB. The institution of Dr. Pahwa has received research support from Ono. The institution of Dr. Pahwa has received research support from Intra-cellular Therapies. The institution of Dr. Pahwa has received research support from Ask Bio. The institution of Dr. Pahwa has received research support from Michael J Fox Foundation . The institution of Dr. Pahwa has received research support from Neuron 23. The institution of Dr. Pahwa has received research support from Roche.
William Ondo, MD (Methodist Neurological Institute) Dr. Ondo has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurocrine. Dr. Ondo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ACADIA. Dr. Ondo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbvie. Dr. Ondo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyowa Kirin. The institution of Dr. Ondo has received research support from Cerevel. The institution of Dr. Ondo has received research support from SCION. The institution of Dr. Ondo has received research support from Harmony. Dr. Ondo has received publishing royalties from a publication relating to health care.
Wen Lv Prof. Lv has nothing to disclose.
Xiaodong Zhu, PhD Dr. Zhu has nothing to disclose.
Yongsheng Hu, MD, PhD Prof. HU has nothing to disclose.
Stuart H. Isaacson, MD, FAAN (Parkinson's Dis & Mov Dis Ctr of Boca Raton) The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for acorda. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for adamas. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neuroderm. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. The institution of Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for adamas. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acadia. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Isaacson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.
Yuan Yuan, MD Mrs. Yuan has nothing to disclose.
Alberto J. Espay, MD, FAAN (University of Cincinnati) Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Tanabe Pharma America (formerly, Neuroderm). Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acorda. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyowa Kirin. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Herantis Pharma. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus (formerly USWorldMeds). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acadia. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Synaps Dx. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bial. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NeuroDiagnostics, Inc (SYNAPS Dx). Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Intrance Medical Systems, Inc.. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Espay has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Praxis Precision Medicines. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Citrus Health. Dr. Espay has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AskBio. The institution of Dr. Espay has received research support from NIH. The institution of Dr. Espay has received research support from Michael J Fox Foundation for Parkinson's Research. Dr. Espay has received intellectual property interests from a discovery or technology relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care. Dr. Espay has received publishing royalties from a publication relating to health care.
David Kreitzman, MD (Parkinsons'S Disease and Movement Disorders Center of Long Island) Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Kreitzman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Cereval. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Acadia Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Acadia Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda Pharmaceutical. Dr. Kreitzman has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Neurocrine. Dr. Kreitzman has received research support from pharma 2b. Dr. Kreitzman has received research support from Neurocrine. Dr. Kreitzman has received research support from Addex. Dr. Kreitzman has received research support from Amneal.
Sheng-Han Kuo, MD, FAAN (Columbia University) Dr. Kuo has nothing to disclose.
Salima Brillman, MD The institution of Dr. Brillman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cala Health. The institution of Dr. Brillman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acorda. The institution of Dr. Brillman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. The institution of Dr. Brillman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acadia. The institution of Dr. Brillman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for USWorldMeds. Dr. Brillman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Brillman has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Acorda. Dr. Brillman has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amneal. Dr. Brillman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acadia. Dr. Brillman has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Adamas. Dr. Brillman has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for USWorld Meds. Dr. Brillman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva.
Holly A. Shill, MD, FAAN (Barrow Neurology Clinics) Dr. Shill has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage Biogen. Dr. Shill has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Shill has received personal compensation in the range of $500-$4,999 for serving as a Consultant for KeifeRx. Dr. Shill has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Praxis Precision Medicine. Dr. Shill has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fasikl Inc. Dr. Shill has received personal compensation in the range of $0-$499 for serving as a Consultant for Boston Scientific. Dr. Shill has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe Pharma America.
Kelly E. Lyons, PhD (University of Kansas Medical Center) Dr. Lyons has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Praxis. Dr. Lyons has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sage. Dr. Lyons has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Parkinson's Foundation. Dr. Lyons has a non-compensated relationship as a President with International Essential Tremor Foundation that is relevant to AAN interests or activities.
Zhi Yang, PhD Mr. Yang has received personal compensation for serving as an employee of Fasikl . An immediate family member of Mr. Yang has received personal compensation for serving as an employee of Fasikl. Mr. Yang has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Fasikl. An immediate family member of Mr. Yang has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Fasikl. Mr. Yang has stock in Fasikl. The institution of Mr. Yang has received research support from Fasikl. The institution of an immediate family member of Mr. Yang has received research support from Fasikl. Mr. Yang has received intellectual property interests from a discovery or technology relating to health care.
Qi Zhao, PhD Prof. Zhao has received personal compensation for serving as an employee of Fasikl. An immediate family member of Prof. Zhao has received personal compensation for serving as an employee of Fasikl. Prof. Zhao has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Fasikl. An immediate family member of Prof. Zhao has stock in Fasikl. The institution of Prof. Zhao has received research support from Fasikl. The institution of an immediate family member of Prof. Zhao has received research support from Fasikl. An immediate family member of Prof. Zhao has received intellectual property interests from a discovery or technology relating to health care.
Zhen Zhang, PhD Dr. Zhang has received personal compensation for serving as an employee of Fasikl Inc. Dr. Zhang has stock in Fasikl Inc. Dr. Zhang has received intellectual property interests from a discovery or technology relating to health care.