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

NCT05842434 | Completed FDA Device

• 1 other identifier: CIP-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Essential Tremor; Parkinson Disease

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Felix

EXPERIMENTAL

Device: Felix

Interventions

Felix 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.

Felix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fasikl Inc.: lead

Study Sites (2)

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Essential Tremor; Parkinson Disease

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: June 6, 2023
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)