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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05842434
• Other study ID #: CIP-1
• Status: Completed
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: November 29, 2023

Study information

• Verified date: December 2023
• Source: Fasikl Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease
• Tremor

Intervention

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.

Locations

Country	Name	City	State
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Fasikl Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to 7 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Tremor Power	Assessed by device sensor.	Baseline to 7 days