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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essential Tremor | Experimental | Patients with essential tremors |
|
| Parkinson's Disease | Experimental | Patients with Parkinson's disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Felix NeuroAI Wristband | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline to 7 days |
| Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Activities of Daily Living (ADL) Subscale |
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Inclusion Criteria:
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.
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard B Dewey III, MD | Parkinson's Disease and Movement Disorders Center of Boca Raton | Principal Investigator |
| Rajesh Pahwa, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40125447 | Result | 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. |
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Between June and November 2023, 25 patients with essential tremors (ET) and 13 patients with Parkinson's disease (PD) were enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Essential Tremor | Patients with essential tremor |
| FG001 | Parkinson's Disease | Patients with Parkinson's disease |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Essential Tremor | Patients with essentail tremor |
| BG001 | Parkinson's Disease | Patients with Parkinson's disease |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of patients at different time points represents the number of patients with analyzable data. | Posted | Mean | Standard Deviation | Points | Baseline to 7 days |
|
From enrollment until end of follow-up, up to 10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Essential Tremor | Patients with essential tremor | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Director | Fasikl Inc. | 800-673-6777 | support@fasikl.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2023 | Apr 23, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020734 | Parkinsonian Disorders |
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|
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. |
| 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) | 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. | Baselinen to 7 days |
| University of Kansas Medical Center |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
Patients with Parkinson's disease
|
|
|
| Secondary | 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) | Patients with at least some improvement | Posted | Count of Participants | Participants | Baseline to 7 days |
|
|
|
| Secondary | 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. | TETRAS ADL data was only available for N=15 ET patients at baseline because this outcome measure was added during the trial. | Posted | Mean | Standard Deviation | Points | Baseline to 7 days |
|
|
|
|
| Secondary | 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) | Patients with at least some improvement | Posted | Count of Participants | Participants | Baseline to 7 days |
|
|
|
| Secondary | 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. | TETRAS ADL data was only available for N=15 ET patients at baseline because this outcome measure was added during the trial. | Posted | Mean | Standard Deviation | Points | Baselinen to 7 days |
|
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|
|
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
| EG001 | Parkinson's Disease | Patients with Parkinson's disease | 0 | 13 | 0 | 13 | 0 | 13 |
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| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Paired t-test |
| 0.06 |
| Mean Difference (Final Values) |
| 5.0 |
| Standard Deviation |
| 3.0 |
| Equivalence |
Whether the change is equivalent to 0 |
| t-test, 2 sided |
Paired t-test |
| 0.03 |
| Mean Difference (Final Values) |
| 6.6 |
| Standard Deviation |
| 3.0 |
| Equivalence |
Whether the change is equivalent to 0 |