Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor

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 Overview

• Status: Completed
• Conditions: Parkinson Disease; Essential Tremor
• Intervention / Treatment: Device: Felix

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. At least 18 years of age.
2. Willing to provide written, informed consent to participate in the study.

3. For subjects with essential tremor (ET):

   1. A clinical diagnosis of ET.
   2. 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.

4. For subjects with Parkinson's disease (PD):

   1. A clinical diagnosis of PD (MDS-PD criteria).
   2. A tremor score of 2 or higher on MDS-UPDRS question 3.15 (postural tremor) or 3.16 (kinetic tremor), OR
   3. 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).
5. Stable dosage of any medication, if applicable, for 30 days prior to study entry.
6. Familiar with operating a touch-screen smartphone and connecting to Wi-Fi internet at home.
7. If necessary, have a dedicated caregiver to help with study required activities, such as putting on the study device, etc.

8. Willing to comply with study protocol requirements including:

   1. Remaining on a stable dosage of current medications, if applicable, during the course of the study.
   2. Remaining on stable caffeine consumption, if applicable, during the course of t the study.
   3. No alcohol consumption on the day before a study visit.

Exclusion Criteria:

1. Prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity.
2. Any current drug or alcohol abuse.
3. Current unstable epileptic conditions with a seizure within 6 months of study entry.
4. Pregnant or nursing subjects and those who plan pregnancy during the course of the study.
5. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at the stimulation site.
6. Known allergy to adhesives.
7. History of Alzheimer's disease or dementia (Montreal Cognitive Assessment (MoCA)≤19).
8. Botulinum Toxin injection for hand tremor within 4 months prior to study enrollment.
9. 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.
10. Subject is unable to communicate with the investigator and staff.
11. Any health condition that in the investigator's opinion should preclude participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Felix	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression of Severity (CGI-S)	Physician rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)	Baseline to 7 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)	Baseline to 7 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)	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 Power	Assessed by device sensor.	Baseline to 7 days
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	Physician rated MDS-UPDRS Part III on a 5-point scale, from 0 (normal) to 4 (severe)	Baseline to 7 days
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.	Baseline to 7 days
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Activities of Daily Living (ADL) Subscale	Patient rating on a 5-point scale, from 0 (normal) to 4 (severely abnormal)	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). TETRAS mADL score is calculated as the sum of all 12 items and ranges from 0 to 52.	Baselinen to 7 days

Collaborators and Investigators

• Sponsor: Fasikl Inc.
• Investigators: Principal Investigator: Rajesh Pahwa, MD, University of Kansas Medical Center; Principal Investigator: Richard B Dewey III, MD, Parkinson's Disease and Movement Disorders Center of Boca Raton

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Parkinson Disease; Tremor; Essential Tremor
• Other Study ID Numbers: CIP-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No