Essential TremorNCT05842434
Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor
A study testing Felix NeuroAI Wristband in people with Essential Tremor and Parkinson Disease, run by Fasikl Inc. at 2 sites in United States.
Trial summary
A prospective, open-label, multi-center pilot study designed to evaluate the safety and effectiveness of the Felix system in the relief of upper limb tremors in adults with essential tremor and Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor, Parkinson Disease
- What is being tested?
- Felix NeuroAI Wristband
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jun 2023to 29 Nov 2023
- 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.
- For subjects with essential tremor (ET):
- A clinical diagnosis of ET.
- For either upper limb, a tremor severity score of 2 or higher as measured by one of the TETRAS items and a total score of 6 or higher across all TETRAS tasks.
- For subjects with Parkinson's disease (PD):
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- A clinical diagnosis of PD (MDS-PD criteria).
- A tremor score of 2 or higher on MDS-UPDRS question 3.15 (postural tremor) or 3.16 (kinetic tremor), OR
- A rest tremor score of 2 or higher on MDS-UPDRS question 3.17 (rest tremor amplitude) in one upper extremity and a score of 2 or higher on MDS-UPDRS question 3.18 (constancy of tremor).
- Stable dosage of any medication, if applicable, for 30 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:
- Remaining on a stable dosage of current medications, if applicable, during the course of the study.
- Remaining on stable caffeine consumption, if applicable, during the course of t the study.
- No alcohol consumption on the day before a study visit.
Who cannot join
- Prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity.
- Any current drug or alcohol abuse.
- Current unstable epileptic conditions with a seizure within 6 months of study entry.
- 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 adhesives.
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- History of Alzheimer's disease or dementia (Montreal Cognitive Assessment (MoCA)≤19).
- Botulinum Toxin injection for hand tremor within 4 months prior to study enrollment.
- 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 staff.
- Any health condition that in the investigator's opinion should preclude participation in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
A prospective, open-label, multi-center pilot study designed to evaluate the safety and effectiveness of the Felix system in the relief of upper limb tremors in adults with essential tremor and Parkinson's disease.
- Conditions
- Essential Tremor, Parkinson Disease
- Being tested
- Felix NeuroAI Wristband
- Medical subject headings
- Essential Tremor, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Felix NeuroAI WristbandDevice
Felix is a wrist-worn, noninvasive, transcutaneous neurostimulation system intended for daily use to suppress hand tremors. An artificial intelligence (AI) algorithm will automatically adjust the stimulation based on each patient's tremor throughout the day.
| Study group | Role | What they receive |
|---|---|---|
| Essential Tremor | Experimental | Patients with essential tremors Receives: Device: Felix NeuroAI Wristband |
| Parkinson's Disease | Experimental | Patients with Parkinson's disease Receives: Device: Felix NeuroAI Wristband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Performance Subscale
A subset of 6 performance tasks will be rated by a physician for each upper limb separately. Each task will be rated from 0 to 4, indicating the increasing severity of tremor, the higher the score, the worse the tremor. This endpoint is the total score of all 6 tasks, the minimum score is 0 and the maximum score is 24.
Measured: Baseline to 7 days
Secondary outcomes (4)
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 to 7 days
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Activities of Daily Living (ADL) Subscale
Patient rating the impact of tremor on each activity of daily living on a 5-point scale, from 0 (normal) to 4 (severely abnormal). This is a composite endpoint that includes the total score of all 12 items of the TETRAS ADL subscale. The minimum score is 0 and the maximum score is 48.
Measured: Baseline to 7 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 to 7 days
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Modified Activities of Daily Living (mADL) Subscale
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 on the TETRAS ADL subsacle and the TETRAS PS subscale is rated from 0 (no tremor) to 4 (severe tremor). TETRAS mADL score is calculated as the sum of all 13 items, the minimum score is 0 and the maximum score is 52.
Measured: Baselinen to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start6 Jun 2023
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fasikl Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard B Dewey III, MD, Principal investigator, Parkinson's Disease and Movement Disorders Center of Boca RatonRajesh Pahwa, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842434
- Sponsor's protocol ID
- CIP-1
- Status last verified
- Jun 2026
- First submitted
- 24 Apr 2023
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dewey R 3rd, Isaacson S, Dewey R Jr, Bette S, Lyons KE, Yang Z, Nguyen AT, Zhao Q, Zhang Z, Pahwa R. A Pilot Study of AI-Controlled Transcutaneous Peripheral Nerve Stimulation for Essential Tremor. Tremor Other Hyperkinet Mov (N Y). 2025 Mar 21;15:10. doi: 10.5334/tohm.991. eCollection 2025.
PubMed 40125447
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor
- ClinicalTrials.gov ID
- NCT05842434
- Acronym / sponsor ID
- CIP-1
- Conditions
- Essential Tremor, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fasikl Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Posted 15 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, open-label, multi-center pilot study designed to evaluate the safety and effectiveness of the Felix system in the relief of upper limb tremors in adults with essential tremor and Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essential Tremor | Experimental | Device: Felix NeuroAI WristbandPatients with essential tremors |
| Parkinson's Disease | Experimental | Device: Felix NeuroAI WristbandPatients with Parkinson's disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- At least 18 years of age.
- Willing to provide written, informed consent to participate in the study.
- For subjects with essential tremor (ET):
- For subjects with Parkinson's disease (PD):
- Stable dosage of any medication, if applicable, for 30 days prior to study entry.
Key exclusion criteria (11 listed)
- Prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity.
- Any current drug or alcohol abuse.
- Current unstable epileptic conditions with a seizure within 6 months of study entry.
- 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.
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 WristbandFelix is a wrist-worn, noninvasive, transcutaneous neurostimulation system intended for daily use to suppress hand tremors. An artificial intelligence (AI) algorithm will automatically adjust the stimulation based on each patient's tremor throughout the day. | Device | Essential Tremor, Parkinson's Disease |
Primary outcome
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Performance Subscale
Time frame: Baseline to 7 days
A subset of 6 performance tasks will be rated by a physician for each upper limb separately. Each task will be rated from 0 to 4, indicating the increasing severity of tremor, the higher the score, the worse the tremor. This endpoint is the total score of all 6 tasks, the minimum score is 0 and the maximum score is 24.
4 secondary outcomes
Clinical Global Impression of Improvement (CGI-I)
Time frame: Baseline to 7 days
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Activities of Daily Living (ADL) Subscale
Time frame: Baseline to 7 days
Patient Global Impression of Improvement (PGI-I)
Time frame: Baseline to 7 days
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Modified Activities of Daily Living (mADL) Subscale
Time frame: Baselinen to 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40125447Dewey R 3rd, Isaacson S, Dewey R Jr, Bette S, Lyons KE, Yang Z, Nguyen AT, Zhao Q, Zhang Z, Pahwa R. A Pilot Study of AI-Controlled Transcutaneous Peripheral Nerve Stimulation for Essential Tremor. Tremor Other Hyperkinet Mov (N Y). 2025 Mar 21;15:10. doi: 10.5334/tohm.991. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Richard B Dewey III, MD principal investigator
Parkinson's Disease and Movement Disorders Center of Boca Raton
Rajesh Pahwa, MD principal investigator
University of Kansas Medical Center
2 sites in 1 country: 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 and Parkinson Disease, run by Fasikl Inc. at 2 sites in United States.
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 16 inclusion and 11 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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 15 Jun 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?
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Performance Subscale (time frame: Baseline to 7 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 NCT05842434, 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 15 Jun 2026.