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

Not Applicable

Completed

• Conditions: Parkinson Disease; Essential Tremor
• Interventions: Device: Felix

• Registration Number: NCT05842434
• Lead Sponsor: Fasikl Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-06
• Study Start: 2023-06-06
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Felix	Felix	-

Primary Outcome Measures

Name	Time	Method
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Activities of Daily Living (ADL) Subscale	Baseline to 7 days	Patient rating on a 5-point scale, from 0 (normal) to 4 (severely abnormal)
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)
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)
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Performance Subscale	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 on a 5-point scale, from 0 (normal) to 4 (severe)
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)
Tremor Power	Baseline to 7 days	Assessed by device sensor.
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Modified Activities of Daily Living (mADL) Subscale	Baselinen to 7 days	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.

Trial Locations

Locations (2)

Parkinson's Disease and Movement Disorders Center of Boca Raton; 🇺🇸 Boca Raton, Florida, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States