Essential Tremor
Conditions
Brief summary
The goal of this clinical study is to compare Felix NeuroAI Wristband and sham device in patients with essential tremor. The main question it aims to answer is: • Is Felix a safe and efficacious treatment for patients with essential tremor? Participants will be treated with either Felix or Sham for a period of up to 90 days. After that, they will be eligible to participate in a long-term, open-label study and be treated with Felix.
Detailed description
The TRANQUIL study is a prospective, randomized, sham-controlled, double-blinded, multi-center, multi-region trial. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Felix NeuroAI Wristband to aid in the relief of upper limb tremor in adults with essential tremor (ET).
Interventions
DEVICEFelix NeuroAI Wristband
The Felix NeuroAI Wristband (Felix) is a wrist-worn, noninvasive, transcutaneous neurostimulation system. Using a proprietary artificial intelligence (AI) algorithm, stimulation will be automatically adapted to patient's needs with the goal to provide full day relief of upper limb tremor.
DEVICESham Device
The sham device has the same exterior appearance and components as the Felix device and is used the same way (without delivering the treatment).
Sponsors
Fasikl Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Subjects will be randomized in a 2:1 ratio to Felix and Sham and be followed for 90 days. After the 90-day follow-up, all subjects will be encouraged to participate in the continued access phase, where subjects randomized to the Sham arm will cross over to Felix and all subjects will be followed up to 1 year (from randomization).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age. * Willing to provide written, informed consent to participate in the study. * A clinical diagnosis of ET by a movement disorder specialist. * For the dominant hand, a tremor severity score of 2 or higher as measured by one of the TETRAS Performance Subscale (PS) tasks (items 4, 6, 7, and 8) and a total score of 7 or higher across these items. If applicable, this must be met while the patient is on ET treatment. * Stable dosage of anti-tremor medications, if applicable, for 30 days prior to study entry. * Stable dosage of antidepressant medications, if applicable, for 90 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: 1. Remaining on a stable dosage of anti-tremor and antidepressant medications, if applicable, during the course of the study. 2. Do not start any new anti-tremor treatment during the course of the study (except the assigned treatment in the study). 3. Remaining on stable caffeine consumption, if applicable, during the course of the study. 4. No alcohol or marijuana consumption the day before a study visit. 5. Do not share study/device-related information on the internet or with other study patients.
Exclusion criteria
* Prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity. * Prior surgical intervention for ET such as deep brain stimulation or thalamotomy. * Moderate to severe alcohol use disorder (AUD) as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) (the presence of at least 4 symptoms or more). * Any current drug abuse. * Use of recreational drugs other than marijuana. * Current unstable epileptic conditions with a seizure within 6 months of study entry. * Other possible causes of tremor such as drug-induced tremor, enhanced physiological tremor, dystonia, and Parkinson's disease. * 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 adhesive bandages. * The presence of any cognitive or other impairment that in the judgement of the investigator will impede the assessment of study outcomes. * Botulinum Toxin injection for hand tremor within 4 months prior to study enrollment. * History of use of other transcutaneous afferent patterned stimulation (TAPS) devices such as Cala Trio. * 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 study staff. * Any health condition that in the investigator's opinion should preclude participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Modified Activities of Daily Living (mADL) Score From Baseline Pre-stimulation to Day 90 | 90 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 is scored from 0 to 4, indicating increasing severity of tremor. TETRAS mADL score is calculated as the sum of all 13 items and ranges from 0 to 52. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Modified Activities of Daily Living (mADL) Score From Baseline Pre-stimulation to 14 Days, 30 Days, 60 Days | 14 days, 30 days, and 60 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 is scored from 0 to 4, indicating increasing severity of tremor. TETRAS mADL score is calculated as the sum of all 13 items and ranges from 0 to 52. |
| Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Dominant Hand Score | Baseline, 30 days, and 90 days | The sum of TETRAS PS items 4 (3 sub-items), 6, 7, and 8 for the dominant hand. Each item is scored by physician from 0 to 4, indicating increasing severity of tremor. TETRAS PS score is calculated as the sum of all 6 items and ranges from 0 to 24. Items 4 and 8 can only assess in-clinic, because clinical follow-up at 14 days and 60 days are conducted remotely, this outcome measure is not available for those timepoints. |
| Clinical Global Impression of Severity (CGI-S) | Baseline, 30 days, and 90 days | Physician rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor) |
| Patient Global Impression of Severity (PGI-S) | Baseline, 14 days, 30 days, 60 days, and 90 days | Patient rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor) |
| Clinical Global Impression of Improvement (CGI-I) | Baseline, 30 days, and 90 days | Physician rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse) |
| Patient Global Impression of Improvement (PGI-I) | Baseline, 14 days, 30 days, 60 days, and 90 days | Patient rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse) |
| Quality of Life in Essential Tremor Questionnaire (QUEST) | Baseline and 90 days | QUEST Total activity and psychosocial score is a 27-item scale that covers Work and Finances, Hobbies and Leisure, Physical, and Psychosocial aspects of QOL. Each item is rated based on how frequent does tremor interfere with this activity, the answers are Never/No (0), Rarely (1), Sometimes (2), Frequently (3) Always/Yes (4). The final total score was calculated: the sum of individual scores / total possible points (i.e., 27x4) times 100. |
Countries
China, United States
Participant flow
Recruitment details
During the Randomized Phase, patients were randomized 2:1 (Felix:sham) and followed up to 90 days. The primary endpoint of the study was based on the randomized phase data. During the Extension Phase (90 days to 1 year), all patients who completed 90 day follow-up will be invited and encouraged to participate and be followed to 1 year. Patients in the Sham group will cross-over to Felix and be followed from 90days to 1 year. Data from both phases will be published and reported afterwards.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.2 Year STANDARD_DEVIATION 11.4 |
| Current ET medication | 17 Participants |
| Duration of ET | 11.6 Year STANDARD_DEVIATION 13.9 |
| Family history of ET | 26 Participants |
| Prior ET treatment | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 66 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 59 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 39 Participants |
| TETRAS mADL score | 29.5 Point STANDARD_DEVIATION 8 |
| TETRAS PS score | 12.5 Point STANDARD_DEVIATION 3.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 83 | 0 / 42 |
| other Total, other adverse events | 28 / 83 | 2 / 42 |
| serious Total, serious adverse events | 0 / 83 | 0 / 42 |
Outcome results
None listed