Essential Tremor, Parkinson Disease
Conditions
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.
Interventions
DEVICEFelix NeuroAI Wristband
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.
Sponsors
Fasikl Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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, the higher the score, the worse the tremor. This endpoint is the total score of all 6 tasks, the minimum score is 0 and the maximum score is 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) Activities of Daily Living (ADL) Subscale | Baseline to 7 days | Patient rating the impact of tremor on each activity of daily living on a 5-point scale, from 0 (normal) to 4 (severely abnormal). This is a composite endpoint that includes the total score of all 12 items of the TETRAS ADL subscale. The minimum score is 0 and the maximum score is 48. |
| 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) |
| 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). Each item on the TETRAS ADL subsacle and the TETRAS PS subscale is rated from 0 (no tremor) to 4 (severe tremor). TETRAS mADL score is calculated as the sum of all 13 items, the minimum score is 0 and the maximum score is 52. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRichard B Dewey III, MD
Parkinson's Disease and Movement Disorders Center of Boca Raton
PRINCIPAL_INVESTIGATORRajesh Pahwa, MD
University of Kansas Medical Center
Participant flow
Recruitment details
Between June and November 2023, 25 patients with essential tremors (ET) and 13 patients with Parkinson's disease (PD) were enrolled into the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 72.5 Years STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 13 |
| other Total, other adverse events | 1 / 25 | 0 / 13 |
| serious Total, serious adverse events | 0 / 25 | 0 / 13 |
Outcome results
None listed