Trial Outcomes & Findings for Wearable Sensor for Responsive DBS for ET (NCT NCT03051178)
NCT ID: NCT03051178
Last Updated: 2024-04-19
Results Overview
Responsive deep brain stimulation as an effective alternative to continuous deep brain stimulation. Clinical Tremor Rating Scale (TRS), rated by a blinded neurologist, during responsive brain stimulation will be compared to scores during continuous deep brain stimulation and no stimulation. The minimum and maximum score range for this scale is 0-80, with higher score indicating worse outcome.
COMPLETED
NA
17 participants
30 minutes during one monthly visit after clinical continuous deep brain stimulation is optimized.
2024-04-19
Participant Flow
17 patients were enrolled into the single arm study. 5 patients withdrew from the study. We are comparing their clinical Tremor Rating Scores (TRS) for three conditions: deep brain stimulation (DBS) OFF, standard (continuous) DBS, and responsive DBS (the trial condition).
Participant milestones
| Measure |
Subjects With Essential Tremor
This cohort will receive deep brain stimulation (DBS) therapy responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
Responsive deep brain stimulation: Responsive deep brain stimulation (R-DBS) therapy will be delivered responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
|
|---|---|
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Overall Study
STARTED
|
17
|
|
Overall Study
Implementation of Responsive DBS Based on Wearable Sensors
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Subjects With Essential Tremor
This cohort will receive deep brain stimulation (DBS) therapy responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
Responsive deep brain stimulation: Responsive deep brain stimulation (R-DBS) therapy will be delivered responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Wearable Sensor for Responsive DBS for ET
Baseline characteristics by cohort
| Measure |
Subjects With Essential Tremor
n=17 Participants
This cohort will receive deep brain stimulation (DBS) therapy responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
Responsive deep brain stimulation: Responsive deep brain stimulation (R-DBS) therapy will be delivered responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
The clinical tremor rating scale (TRS) with R-DBS will be compare to no DBS and continuous DBS TRS scores.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
74.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes during one monthly visit after clinical continuous deep brain stimulation is optimized.Population: We statistically compared the Tremor Rating Scale (TRS) scores for responsive deep brain stimulation (R-DBS) to standard continuous DBS (cDBS) and to NO DBS.
Responsive deep brain stimulation as an effective alternative to continuous deep brain stimulation. Clinical Tremor Rating Scale (TRS), rated by a blinded neurologist, during responsive brain stimulation will be compared to scores during continuous deep brain stimulation and no stimulation. The minimum and maximum score range for this scale is 0-80, with higher score indicating worse outcome.
Outcome measures
| Measure |
Subjects With Essential Tremor
n=12 Participants
This cohort will receive deep brain stimulation (DBS) therapy responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
Responsive deep brain stimulation: Responsive deep brain stimulation (R-DBS) therapy will be delivered responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
|
|---|---|
|
Clinical Rating Scale for Tremor (CRST)
DBS Off
|
18.39534884 score on a scale
Standard Deviation 9.191454455
|
|
Clinical Rating Scale for Tremor (CRST)
Continuous DBS
|
13.97674419 score on a scale
Standard Deviation 5.616677429
|
|
Clinical Rating Scale for Tremor (CRST)
Responsive DBS
|
14.58139535 score on a scale
Standard Deviation 5.197217929
|
Adverse Events
Subjects With Essential Tremor
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place