AI-Powered wristband aims to quiet essential tremor without drugs
NCT ID NCT06235190
First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study tests a wrist-worn device called Felix that uses artificial intelligence to deliver gentle nerve stimulation, aiming to reduce hand tremors in people with essential tremor. Participants wear the device daily for up to 90 days and are compared to a group using a sham (inactive) device. The goal is to see if the device safely improves tremor-related daily activities and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Felix NeuroAI Wristband (transcutaneous neurostimulation device)
- What this could lead to
- If it works, this could offer a noninvasive, drug-free option for managing essential tremor throughout the day.
- What could go wrong
- This is an early-stage study with a sham comparison, so results may not confirm lasting benefit. The device may not work for everyone, and individual responses can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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125 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * At least 18 years of age. * Willing to provide written, informed consent to participate in the study. * A clinical diagnosis of ET by a movement disorder specialist. * For the dominant hand, a tremor severity score of 2 or higher as measured by one of the TETRAS Performance Subscale (PS) tasks (items 4, 6, 7, and 8) and a total score of 7 or higher across these items. If applicable, this must be met while the patient is on ET treatment. * Stable dosage of anti-tremor medications, if applicable, for 30 days prior to study entry. * Stable dosage of antidepressant medications, if applicable, for 90 days prior to study entry. * Familiar with operating a touch-screen smartphone and connecting to Wi-Fi internet at home. * If necessary, have a dedicated caregiver to help with study required activities, such as putting on the study device, etc. * Willing to comply with study protocol requirements including: 1. Remaining on a stable dosage of anti-tremor and antidepressant medications, if applicable, during the course of the study. 2. Do not start any new anti-tremor treatment during the course of the study (except the assigned treatment in the study). 3. Remaining on stable caffeine consumption, if applicable, during the course of the study. 4. No alcohol or marijuana consumption the day before a study visit. 5. Do not share study/device-related information on the internet or with other study patients. Exclusion Criteria: * Prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity. * Prior surgical intervention for ET such as deep brain stimulation or thalamotomy. * Moderate to severe alcohol use disorder (AUD) as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) (the presence of at least 4 symptoms or more). * Any current drug abuse. * Use of recreational drugs other than marijuana. * Current unstable epileptic conditions with a seizure within 6 months of study entry. * Other possible causes of tremor such as drug-induced tremor, enhanced physiological tremor, dystonia, and Parkinson's disease. * Pregnant or nursing subjects and those who plan pregnancy during the course of the study. * Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at the stimulation site. * Known allergy to adhesive bandages. * The presence of any cognitive or other impairment that in the judgement of the investigator will impede the assessment of study outcomes. * Botulinum Toxin injection for hand tremor within 4 months prior to study enrollment. * History of use of other transcutaneous afferent patterned stimulation (TAPS) devices such as Cala Trio. * Subject is currently participating or has participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor. * Subject is unable to communicate with the investigator and study staff. * Any health condition that in the investigator's opinion should preclude participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
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Columbia University Irving Medical Center
New York, New York, 10032, United States
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Houston Methodist Research Institute
Houston, Texas, 77030, United States
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Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
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Parkinson's Research Centers of America - Long Island
Commack, New York, 11725, United States
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Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, 94301, United States
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Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
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The University Of Kansas Medical Center
Kansas City, Kansas, 66160, United States
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Tianjin Medical University General Hospital
Tianjin, 300052, China
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University of Cincinnati
Cincinnati, Ohio, 45221, United States
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Xuanwu Hospital Capital Medical University
Beijing, 100053, China
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- Can MRI reveal the Brain's response to deep brain stimulation?