Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Felix
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Device: Felix
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.
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Outcome Measures
Primary Outcome Measures
- Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) [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.
- Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Baseline to 7 days]
Physician rated MDS-UPDRS Part III
- Clinical Global Impression of Severity (CGI-S) [Baseline to 7 days]
Physician rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
- Clinical Global Impression of Improvement (CGI-I) [Baseline to 7 days]
Physician rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)
- Bain & Findley Activities of Daily Living (BF-ADL) scale [Baseline to 7 days]
A subset of 8 tasks of BF-ADL will be rated by the patient on a 4-point scale, from 1 (able to do the activity without difficulty) to 4 (cannot do the activity by oneself)
- Patient Global Impression of Severity (PGI-S) [Baseline to 7 days]
Patient rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
- Patient Global Impression of Improvement (PGI-I) [Baseline to 7 days]
Patient rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)
- Tremor Power [Baseline to 7 days]
Assessed by device sensor.
Eligibility Criteria
Criteria
Inclusion Criteria:
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At least 18 years of age.
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Willing to provide written, informed consent to participate in the study.
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For subjects with essential tremor (ET):
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A clinical diagnosis of ET.
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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.
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For subjects with Parkinson's disease (PD):
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A clinical diagnosis of PD (MDS-PD criteria).
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A tremor score of 2 or higher on MDS-UPDRS question 3.15 (postural tremor) or 3.16 (kinetic tremor), OR
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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).
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Stable dosage of any medication, if applicable, for 30 days prior to study entry.
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Willing to comply with study protocol requirements including:
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Remaining on a stable dosage of current medications, if applicable, during the course of the study.
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Remaining on stable caffeine consumption, if applicable, during the course of t the study.
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No alcohol consumption on the day before a study visit.
Exclusion Criteria:
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Prior electrical medical device implantation (except for pacemaker or implantable cardioverter defibrillator) such as deep brain stimulator, vagus nerve stimulator, responsive neurostimulator, etc.
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Prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity.
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Any current drug or alcohol abuse.
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Current unstable epileptic conditions with a seizure within 6 months of study entry.
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Previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife radiosurgical thalamotomy, and focused ultrasound for the treatment of tremor.
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Pregnant or nursing subjects and those who plan pregnancy during the course of the study.
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Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at the stimulation site.
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History of Alzheimer's disease or dementia (Montreal Cognitive Assessment (MoCA)≤19).
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Botulinum Toxin injection for hand tremor within 4 months prior to study enrollment.
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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.
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Subject is unable to communicate with the investigator and staff.
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Any health condition that in the investigator's opinion should preclude participation in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | United States | 33486 |
| 2 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
Sponsors and Collaborators
- Fasikl Inc.
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP-1