Trial Outcomes & Findings for Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential Tremor (NCT NCT06235190)
NCT ID: NCT06235190
Last Updated: 2026-07-09
Results Overview
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.
COMPLETED
NA
125 participants
90 days
2026-07-09
Participant Flow
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.
Participant milestones
| Measure |
Felix NeuroAI Wristband
Patients randomized to Felix NeuroAI Wristband
|
Sham Device
Patients randomized to Sham Device
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
42
|
|
Overall Study
COMPLETED
|
62
|
36
|
|
Overall Study
NOT COMPLETED
|
21
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential Tremor
Baseline characteristics by cohort
| Measure |
Total
n=125 Participants
Total of all reporting groups
|
Felix NeuroAI Wristband
n=83 Participants
Patients randomized to Felix NeuroAI Wristband
|
Sham Device
n=42 Participants
Patients randomized to Sham Device
|
|---|---|---|---|
|
Age, Continuous
|
64.9 Year
STANDARD_DEVIATION 13.1 • n=40 Participants
|
63.8 Year
STANDARD_DEVIATION 13.9 • n=20 Participants
|
67.2 Year
STANDARD_DEVIATION 11.4 • n=20 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=40 Participants
|
44 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=40 Participants
|
39 Participants
n=20 Participants
|
24 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
66 Participants
n=40 Participants
|
42 Participants
n=20 Participants
|
24 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=40 Participants
|
41 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Duration of ET
|
11.4 Year
STANDARD_DEVIATION 13.1 • n=40 Participants
|
11.3 Year
STANDARD_DEVIATION 12.8 • n=20 Participants
|
11.6 Year
STANDARD_DEVIATION 13.9 • n=20 Participants
|
|
Prior ET treatment
|
66 Participants
n=40 Participants
|
45 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
|
Current ET medication
|
50 Participants
n=40 Participants
|
33 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
|
Family history of ET
|
68 Participants
n=40 Participants
|
42 Participants
n=20 Participants
|
26 Participants
n=20 Participants
|
|
TETRAS PS score
|
12.5 Point
STANDARD_DEVIATION 3.1 • n=40 Participants
|
12.3 Point
STANDARD_DEVIATION 3.1 • n=20 Participants
|
12.9 Point
STANDARD_DEVIATION 3.1 • n=20 Participants
|
|
TETRAS mADL score
|
29.8 Point
STANDARD_DEVIATION 7.5 • n=40 Participants
|
29.9 Point
STANDARD_DEVIATION 7.3 • n=20 Participants
|
29.5 Point
STANDARD_DEVIATION 8.0 • n=20 Participants
|
PRIMARY outcome
Timeframe: 90 daysTETRAS 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.
Outcome measures
| Measure |
Felix NeuroAI Wristband
n=62 Participants
Patients randomized to Felix NeuroAI Wristband
|
Sham Device
n=36 Participants
Patients randomized to Sham Device
|
|---|---|---|
|
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
|
-6.9 Point
Standard Deviation 6.0
|
-2.7 Point
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 14 days, 30 days, and 60 daysPopulation: Number of subjects analyzed was different for different time points.
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.
Outcome measures
| Measure |
Felix NeuroAI Wristband
n=74 Participants
Patients randomized to Felix NeuroAI Wristband
|
Sham Device
n=38 Participants
Patients randomized to Sham Device
|
|---|---|---|
|
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
|
-4.4 Point
Standard Deviation 4.2
|
-3.5 Point
Standard Deviation 5.1
|
|
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
30 Days
|
-5.1 Point
Standard Deviation 4.4
|
-3.5 Point
Standard Deviation 4.8
|
|
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
60 Days
|
-6.0 Point
Standard Deviation 5.0
|
-3.3 Point
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline, 30 days, and 90 daysPopulation: Number of subjects analyzed was different between different time points
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.
Outcome measures
| Measure |
Felix NeuroAI Wristband
n=83 Participants
Patients randomized to Felix NeuroAI Wristband
|
Sham Device
n=42 Participants
Patients randomized to Sham Device
|
|---|---|---|
|
Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Dominant Hand Score
Baseline
|
12.3 Point
Standard Deviation 3.1
|
12.9 Point
Standard Deviation 3.1
|
|
Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Dominant Hand Score
30 Days
|
10.5 Point
Standard Deviation 2.9
|
11.5 Point
Standard Deviation 3.0
|
|
Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Dominant Hand Score
90 Days
|
9.8 Point
Standard Deviation 3.3
|
11.1 Point
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline, 30 days, and 90 daysPopulation: Number of subjects analyzed was different for each time point.
Physician rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
Outcome measures
| Measure |
Felix NeuroAI Wristband
n=83 Participants
Patients randomized to Felix NeuroAI Wristband
|
Sham Device
n=42 Participants
Patients randomized to Sham Device
|
|---|---|---|
|
Clinical Global Impression of Severity (CGI-S)
90 Days
|
3.5 Point
Standard Deviation 0.8
|
4.1 Point
Standard Deviation 1.1
|
|
Clinical Global Impression of Severity (CGI-S)
Baseline
|
4.2 Point
Standard Deviation 1.1
|
4.5 Point
Standard Deviation 1.1
|
|
Clinical Global Impression of Severity (CGI-S)
30 Days
|
3.6 Point
Standard Deviation 0.9
|
4.1 Point
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, 14 days, 30 days, 60 days, and 90 daysPopulation: Number of subjects analyzed was different for each time point
Patient rating on a 7-point scale, from 1 (normal) to 7 (amongst the most extreme tremor)
Outcome measures
| Measure |
Felix NeuroAI Wristband
n=83 Participants
Patients randomized to Felix NeuroAI Wristband
|
Sham Device
n=41 Participants
Patients randomized to Sham Device
|
|---|---|---|
|
Patient Global Impression of Severity (PGI-S)
Baseline
|
4.4 Point
Standard Deviation 1.1
|
4.5 Point
Standard Deviation 1.3
|
|
Patient Global Impression of Severity (PGI-S)
14 Days
|
4.0 Point
Standard Deviation 1.2
|
4.1 Point
Standard Deviation 1.2
|
|
Patient Global Impression of Severity (PGI-S)
30 Days
|
3.9 Point
Standard Deviation 1.0
|
4.0 Point
Standard Deviation 1.0
|
|
Patient Global Impression of Severity (PGI-S)
60 Days
|
3.8 Point
Standard Deviation 1.0
|
4.2 Point
Standard Deviation 1.1
|
|
Patient Global Impression of Severity (PGI-S)
90 Days
|
3.7 Point
Standard Deviation 1.1
|
4.1 Point
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline, 30 days, and 90 daysPopulation: Number of subjects analyzed was different for each time point
Physician rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)
Outcome measures
| Measure |
Felix NeuroAI Wristband
n=81 Participants
Patients randomized to Felix NeuroAI Wristband
|
Sham Device
n=42 Participants
Patients randomized to Sham Device
|
|---|---|---|
|
Clinical Global Impression of Improvement (CGI-I)
Any improvement after in-clinic treatment
|
53 Participants
|
27 Participants
|
|
Clinical Global Impression of Improvement (CGI-I)
Any improvement at 30 Days
|
47 Participants
|
19 Participants
|
|
Clinical Global Impression of Improvement (CGI-I)
Any improvement at 90 Days
|
43 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline, 14 days, 30 days, 60 days, and 90 daysPopulation: Number of subjects analyzed was different for each time point.
Patient rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)
Outcome measures
| Measure |
Felix NeuroAI Wristband
n=81 Participants
Patients randomized to Felix NeuroAI Wristband
|
Sham Device
n=41 Participants
Patients randomized to Sham Device
|
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I)
Any improvement post stimulation in-clinic
|
46 Participants
|
24 Participants
|
|
Patient Global Impression of Improvement (PGI-I)
Any improvement at 14 Days
|
45 Participants
|
19 Participants
|
|
Patient Global Impression of Improvement (PGI-I)
Any improvement at 30 Days
|
40 Participants
|
15 Participants
|
|
Patient Global Impression of Improvement (PGI-I)
Any improvement at 60 Days
|
42 Participants
|
18 Participants
|
|
Patient Global Impression of Improvement (PGI-I)
Any improvement at 90 Days
|
42 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline and 90 daysPopulation: Number of subjects analyzed was different for different time points
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.
Outcome measures
| Measure |
Felix NeuroAI Wristband
n=83 Participants
Patients randomized to Felix NeuroAI Wristband
|
Sham Device
n=42 Participants
Patients randomized to Sham Device
|
|---|---|---|
|
Quality of Life in Essential Tremor Questionnaire (QUEST)
Total activity and psychosocial score at Baseline
|
34.5 Point
Standard Deviation 17.7
|
33.6 Point
Standard Deviation 18.6
|
|
Quality of Life in Essential Tremor Questionnaire (QUEST)
Total activity and psychosocial score at 90 Days
|
26.5 Point
Standard Deviation 15.7
|
30.9 Point
Standard Deviation 18.7
|
Adverse Events
Felix NeuroAI Wristband
Sham Device
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Felix NeuroAI Wristband
n=83 participants at risk
Patients randomized to Felix NeuroAI Wristband
|
Sham Device
n=42 participants at risk
Patients randomized to Sham Device
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Moderate skin irritation
|
3.6%
3/83 • 90 Days
|
4.8%
2/42 • 90 Days
|
|
Skin and subcutaneous tissue disorders
Mild skin irritation
|
28.9%
24/83 • 90 Days
|
0.00%
0/42 • 90 Days
|
|
General disorders
Arthralgia
|
1.2%
1/83 • 90 Days
|
0.00%
0/42 • 90 Days
|
|
General disorders
Worsening of arthritis in thumb
|
1.2%
1/83 • 90 Days
|
0.00%
0/42 • 90 Days
|
|
General disorders
Limb discomfort
|
1.2%
1/83 • 90 Days
|
0.00%
0/42 • 90 Days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
1/83 • 90 Days
|
0.00%
0/42 • 90 Days
|
|
General disorders
Nausea
|
1.2%
1/83 • 90 Days
|
0.00%
0/42 • 90 Days
|
|
Musculoskeletal and connective tissue disorders
Involuntary muscle contractions
|
1.2%
1/83 • 90 Days
|
0.00%
0/42 • 90 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place