Essential TremorTRANQUILNCT06235190
Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential Tremor
A study testing Felix NeuroAI Wristband in people with Essential Tremor, run by Fasikl Inc. at 12 sites in 2 countries.
Trial summary
The goal of this clinical study is to compare Felix NeuroAI Wristband and sham device in patients with essential tremor. The main question it aims to answer is: Is Felix a safe and efficacious treatment for patients with essential tremor? Participants will be treated with either Felix or Sham for a period of up to 90… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Felix NeuroAI Wristband
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 27 Feb 2024to 6 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- Remaining on a stable dosage of anti-tremor and antidepressant medications, if applicable, during the course of the study.
- Do not start any new anti-tremor treatment during the course of the study (except the assigned treatment in the study).
- Remaining on stable caffeine consumption, if applicable, during the course of the study.
- No alcohol or marijuana consumption the day before a study visit.
- Do not share study/device-related information on the internet or with other study patients.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States8 sites
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
University of Cincinnati
Cincinnati, Ohio, 45221
Parkinson's Research Centers of America - Long Island
Commack, New York, 11725
Houston Methodist Research Institute
Houston, Texas, 77030
The University Of Kansas Medical Center
Kansas City, Kansas, 66160
Columbia University Irving Medical Center
New York, New York, 10032
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, 94301
Barrow Neurological Institute
Phoenix, Arizona, 85013
China4 sites
Xuanwu Hospital Capital Medical University
Beijing, 100053
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Tianjin Medical University General Hospital
Tianjin, 300052
About this study
Official title: Assessment of a Novel NeuroAI-powered Transcutaneous Neuromodulation Device in Alleviating Tremor Symptoms and Enhancing Quality of Life for Patients With Upper Limb Essential Tremor
The goal of this clinical study is to compare Felix NeuroAI Wristband and sham device in patients with essential tremor. The main question it aims to answer is:
- Is Felix a safe and efficacious treatment for patients with essential tremor?
Participants will be treated with either Felix or Sham for a period of up to 90 days. After that, they will be eligible to participate in a long-term, open-label study and be treated with Felix.
Read the detailed description
The TRANQUIL study is a prospective, randomized, sham-controlled, double-blinded, multi-center, multi-region trial. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Felix NeuroAI Wristband to aid in the relief of upper limb tremor in adults with essential tremor (ET).
- Conditions
- Essential Tremor
- Being tested
- Felix NeuroAI Wristband, Sham Device
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Felix NeuroAI WristbandDevice
The Felix NeuroAI Wristband (Felix) is a wrist-worn, noninvasive, transcutaneous neurostimulation system. Using a proprietary artificial intelligence (AI) algorithm, stimulation will be automatically adapted to patient's needs with the goal to provide full day relief of upper limb tremor.
Sham DeviceDevice
The sham device has the same exterior appearance and components as the Felix device and is used the same way (without delivering the treatment).
| Study group | Role | What they receive |
|---|---|---|
| Felix NeuroAI Wristband | Experimental | Not described Receives: Device: Felix NeuroAI Wristband |
| Sham Device | Sham comparator | Not described Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Modified Activities of Daily Living (mADL) Score From Baseline Pre-stimulation to Day 90
TETRAS mADL score is a composite sum of items 2 to 11 of the TETRAS ADL subscale and items 6 (bilateral) and 7 (dominant hand) of the TETRAS performance subscale (PS). Each item is scored from 0 to 4, indicating increasing severity of tremor. TETRAS mADL score is calculated as the sum of all 13 items and ranges from 0 to 52.
Measured: 90 days
Secondary outcomes (7)
Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Modified Activities of Daily Living (mADL) Score From Baseline Pre-stimulation to 14 Days, 30 Days, 60 Days
TETRAS mADL score is a composite sum of items 2 to 11 of the TETRAS ADL subscale and items 6 (bilateral) and 7 (dominant hand) of the TETRAS performance subscale (PS). Each item is scored from 0 to 4, indicating increasing severity of tremor. TETRAS mADL score is calculated as the sum of all 13 items and ranges from 0 to 52.
Measured: 14 days, 30 days, and 60 days
Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Dominant Hand Score
The sum of TETRAS PS items 4 (3 sub-items), 6, 7, and 8 for the dominant hand. Each item is scored by physician from 0 to 4, indicating increasing severity of tremor. TETRAS PS score is calculated as the sum of all 6 items and ranges from 0 to 24.
Items 4 and 8 can only assess in-clinic, because clinical follow-up at 14 days and 60 days are conducted remotely, this outcome measure is not available for those timepoints.
Measured: Baseline, 30 days, and 90 days
Clinical Global Impression of Severity (CGI-S)
Physician rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
Measured: Baseline, 30 days, and 90 days
Patient Global Impression of Severity (PGI-S)
Patient rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
Measured: Baseline, 14 days, 30 days, 60 days, and 90 days
Clinical Global Impression of Improvement (CGI-I)
Physician rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)
Measured: Baseline, 30 days, and 90 days
Patient Global Impression of Improvement (PGI-I)
Patient rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)
Measured: Baseline, 14 days, 30 days, 60 days, and 90 days
Quality of Life in Essential Tremor Questionnaire (QUEST)
QUEST Total activity and psychosocial score is a 27-item scale that covers Work and Finances, Hobbies and Leisure, Physical, and Psychosocial aspects of QOL. Each item is rated based on how frequent does tremor interfere with this activity, the answers are Never/No (0), Rarely (1), Sometimes (2), Frequently (3) Always/Yes (4). The final total score was calculated: the sum of individual scores / total possible points (i.e., 27x4) times 100.
Measured: Baseline and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start27 Feb 2024
- Primary completion31 Oct 2024
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized in a 2:1 ratio to Felix and Sham and be followed for 90 days. After the 90-day follow-up, all subjects will be encouraged to participate in the continued access phase, where subjects randomized to the Sham arm will cross over to Felix and all subjects will be followed up to 1 year (from randomization).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fasikl Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235190
- Sponsor's protocol ID
- FSK-CIP-2
- Acronym
- TRANQUIL
- Status last verified
- Jun 2026
- First submitted
- 11 Jan 2024
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Ondo WG, Lv W, Zhu X, Hu Y, Isaacson SH, Yuan Y, Espay AJ, Kreitzman D, Kuo SH, Brillman S, Shill HA, Lyons KE, Yang Z, Zhao Q, Zhang Z, Pahwa R. Transcutaneous Peripheral Nerve Stimulation for Essential Tremor: A Randomized Clinical Trial. JAMA Neurol. 2025 Dec 1;82(12):1235-1242. doi: 10.1001/jamaneurol.2025.3905.
PubMed 41114984
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Novel NeuroAI-powered Transcutaneous Neuromodulation Device in Alleviating Tremor Symptoms and Enhancing Quality of Life for Patients With Upper Limb Essential Tremor
- ClinicalTrials.gov ID
- NCT06235190
- Acronym / sponsor ID
- TRANQUIL / FSK-CIP-2
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Fasikl Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Posted 9 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to compare Felix NeuroAI Wristband and sham device in patients with essential tremor. The main question it aims to answer is:
- Is Felix a safe and efficacious treatment for patients with essential tremor?
Participants will be treated with either Felix or Sham for a period of up to 90 days. After that, they will be eligible to participate in a long-term, open-label study and be treated with Felix.
Detailed description
The TRANQUIL study is a prospective, randomized, sham-controlled, double-blinded, multi-center, multi-region trial. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Felix NeuroAI Wristband to aid in the relief of upper limb tremor in adults with essential tremor (ET).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized in a 2:1 ratio to Felix and Sham and be followed for 90 days. After the 90-day follow-up, all subjects will be encouraged to participate in the continued access phase, where subjects randomized to the Sham arm will cross over to Felix and all subjects will be followed up to 1 year (from randomization).
| Arm | Type | Receives |
|---|---|---|
| Felix NeuroAI Wristband | Experimental | Device: Felix NeuroAI Wristband |
| Sham Device | Sham comparator | Device: Sham Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Felix NeuroAI WristbandThe Felix NeuroAI Wristband (Felix) is a wrist-worn, noninvasive, transcutaneous neurostimulation system. Using a proprietary artificial intelligence (AI) algorithm, stimulation will be automatically adapted to patient's needs with the goal to provide full day relief of upper limb tremor. | Device | Felix NeuroAI Wristband |
| Sham DeviceThe sham device has the same exterior appearance and components as the Felix device and is used the same way (without delivering the treatment). | Device | Sham Device |
Primary outcome
Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Modified Activities of Daily Living (mADL) Score From Baseline Pre-stimulation to Day 90
Time frame: 90 days
TETRAS mADL score is a composite sum of items 2 to 11 of the TETRAS ADL subscale and items 6 (bilateral) and 7 (dominant hand) of the TETRAS performance subscale (PS). Each item is scored from 0 to 4, indicating increasing severity of tremor. TETRAS mADL score is calculated as the sum of all 13 items and ranges from 0 to 52.
7 secondary outcomes
Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Modified Activities of Daily Living (mADL) Score From Baseline Pre-stimulation to 14 Days, 30 Days, 60 Days
Time frame: 14 days, 30 days, and 60 days
Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Dominant Hand Score
Time frame: Baseline, 30 days, and 90 days
Clinical Global Impression of Severity (CGI-S)
Time frame: Baseline, 30 days, and 90 days
Patient Global Impression of Severity (PGI-S)
Time frame: Baseline, 14 days, 30 days, 60 days, and 90 days
Clinical Global Impression of Improvement (CGI-I)
Time frame: Baseline, 30 days, and 90 days
Patient Global Impression of Improvement (PGI-I)
Time frame: Baseline, 14 days, 30 days, 60 days, and 90 days
Quality of Life in Essential Tremor Questionnaire (QUEST)
Time frame: Baseline and 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41114984Ondo WG, Lv W, Zhu X, Hu Y, Isaacson SH, Yuan Y, Espay AJ, Kreitzman D, Kuo SH, Brillman S, Shill HA, Lyons KE, Yang Z, Zhao Q, Zhang Z, Pahwa R. Transcutaneous Peripheral Nerve Stimulation for Essential Tremor: A Randomized Clinical Trial. JAMA Neurol. 2025 Dec 1;82(12):1235-1242. doi: 10.1001/jamaneurol.2025.3905.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Felix NeuroAI Wristband in people with Essential Tremor, run by Fasikl Inc. at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Modified Activities of Daily Living (mADL) Score From Baseline Pre-stimulation to Day 90 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06235190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.