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

Primary Purpose

Essential Tremor, Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Felix
Sponsored by
Fasikl Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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): 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): 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • Parkinson's Disease and Movement Disorders Center of Boca RatonRecruiting
  • University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Felix

Arm Description

Outcomes

Primary Outcome Measures

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.
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)
Clinical Global Impression of Severity (CGI-S)
Physician rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
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)
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)
Patient Global Impression of Severity (PGI-S)
Patient rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
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)
Tremor Power
Assessed by device sensor.

Secondary Outcome Measures

Full Information

First Posted
April 24, 2023
Last Updated
July 31, 2023
Sponsor
Fasikl Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05842434
Brief Title
Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor
Official Title
Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fasikl Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor, Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Felix
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Felix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Performance Subscale
Description
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.
Time Frame
Baseline to 7 days
Title
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Description
Physician rated MDS-UPDRS Part III on a 5-point scale, from 0 (normal) to 4 (severe)
Time Frame
Baseline to 7 days
Title
Clinical Global Impression of Severity (CGI-S)
Description
Physician rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
Time Frame
Baseline to 7 days
Title
Clinical Global Impression of Improvement (CGI-I)
Description
Physician rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)
Time Frame
Baseline to 7 days
Title
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Activities of Daily Living (ADL) Subscale
Description
Patient rating on a 5-point scale, from 0 (normal) to 4 (severely abnormal)
Time Frame
Baseline to 7 days
Title
Patient Global Impression of Severity (PGI-S)
Description
Patient rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
Time Frame
Baseline to 7 days
Title
Patient Global Impression of Improvement (PGI-I)
Description
Patient rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)
Time Frame
Baseline to 7 days
Title
Tremor Power
Description
Assessed by device sensor.
Time Frame
Baseline to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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): 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): 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Zhang, PhD
Phone
6124703441
Email
zhen.zhang@fasikl.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B Dewey III, MD
Organizational Affiliation
Parkinson's Disease and Movement Disorders Center of Boca Raton
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rajesh Pahwa, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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