Trial Outcomes & Findings for Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor (NCT NCT05842434)
NCT ID: NCT05842434
Last Updated: 2026-06-15
Results Overview
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.
COMPLETED
NA
38 participants
Baseline to 7 days
2026-06-15
Participant Flow
Between June and November 2023, 25 patients with essential tremors (ET) and 13 patients with Parkinson's disease (PD) were enrolled into the study.
Participant milestones
| Measure |
Essential Tremor
Patients with essential tremor
|
Parkinson's Disease
Patients with Parkinson's disease
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
13
|
|
Overall Study
COMPLETED
|
17
|
12
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor
Baseline characteristics by cohort
| Measure |
Essential Tremor
n=25 Participants
Patients with essentail tremor
|
Parkinson's Disease
n=13 Participants
Patients with Parkinson's disease
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.0 Years
STANDARD_DEVIATION 7.7 • n=20 Participants
|
75.5 Years
STANDARD_DEVIATION 4.0 • n=20 Participants
|
72.5 Years
STANDARD_DEVIATION 6.8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
34 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline to 7 daysPopulation: Number of patients at different time points represents the number of patients with analyzable data.
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.
Outcome measures
| Measure |
Essential Tremor
n=25 Participants
Patients with Essential Tremor
|
Parkinson's Disease
n=12 Participants
Patients with Parkinson's disease
|
|---|---|---|
|
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Performance Subscale
TETRAS PS Dominant Hand Score at Baseline
|
14.1 Points
Standard Deviation 2.2
|
11.4 Points
Standard Deviation 4.1
|
|
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Performance Subscale
TETRAS PS Dominant Hand Score at 7 Days
|
11.4 Points
Standard Deviation 3.3
|
8.3 Points
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Baseline to 7 daysPopulation: Patients with at least some improvement
Physician rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)
Outcome measures
| Measure |
Essential Tremor
n=17 Participants
Patients with Essential Tremor
|
Parkinson's Disease
n=12 Participants
Patients with Parkinson's disease
|
|---|---|---|
|
Clinical Global Impression of Improvement (CGI-I)
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline to 7 daysPopulation: TETRAS ADL data was only available for N=15 ET patients at baseline because this outcome measure was added during the trial.
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.
Outcome measures
| Measure |
Essential Tremor
n=15 Participants
Patients with Essential Tremor
|
Parkinson's Disease
n=12 Participants
Patients with Parkinson's disease
|
|---|---|---|
|
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Activities of Daily Living (ADL) Subscale
TETRAS ADL Score at Baseline
|
29.9 Points
Standard Deviation 4.2
|
25.5 Points
Standard Deviation 3.4
|
|
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Activities of Daily Living (ADL) Subscale
TETRAS ADL Score at 7 Days
|
20.7 Points
Standard Deviation 8.7
|
20.5 Points
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline to 7 daysPopulation: Patients with at least some improvement
Patient rating of tremor improvement on a 7-point scale, from 1 (very much improved) to 7 (very much worse)
Outcome measures
| Measure |
Essential Tremor
n=17 Participants
Patients with Essential Tremor
|
Parkinson's Disease
n=12 Participants
Patients with Parkinson's disease
|
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I)
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baselinen to 7 daysPopulation: TETRAS ADL data was only available for N=15 ET patients at baseline because this outcome measure was added during the trial.
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.
Outcome measures
| Measure |
Essential Tremor
n=15 Participants
Patients with Essential Tremor
|
Parkinson's Disease
n=12 Participants
Patients with Parkinson's disease
|
|---|---|---|
|
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Modified Activities of Daily Living (mADL) Subscale
TETRAS mADL Score at Baseline
|
34.8 Points
Standard Deviation 4.8
|
30.4 Points
Standard Deviation 3.1
|
|
Tremor Research Group Essential Tremor Rating Assessment (TETRAS) Modified Activities of Daily Living (mADL) Subscale
TETRAS mADL Score at 7 Days
|
24.8 Points
Standard Deviation 9.5
|
23.8 Points
Standard Deviation 2.7
|
Adverse Events
Essential Tremor
Parkinson's Disease
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Essential Tremor
n=25 participants at risk
Patients with essential tremor
|
Parkinson's Disease
n=13 participants at risk
Patients with Parkinson's disease
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
4.0%
1/25 • From enrollment until end of follow-up, up to 10 days
|
0.00%
0/13 • From enrollment until end of follow-up, up to 10 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place