Trial Outcomes & Findings for Atlas Predicted DBS Settings in Essential Tremor (NCT NCT02678429)
NCT ID: NCT02678429
Last Updated: 2023-03-27
Results Overview
Tremor quantification
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
1 month
Results posted on
2023-03-27
Participant Flow
Participant milestones
| Measure |
DBS Programming, Standard of Care
DBS settings determined from the standard Neurologist symptomatic response, first
Change DBS programming: Patient will change thier settings to move from one group to the other to trial the other DBS settings
|
DBS Progamming From Atlas
DBS settings determined from the a functional atlas only,first
Change DBS programming: Patient will change thier settings to move from one group to the other to trial the other DBS settings
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
DBS Programming, Standard of Care
n=3 Participants
DBS settings determined from the standard Neurologist symptomatic response, first
Change DBS programming: Patient will change thier settings to move from one group to the other to trial the other DBS settings
|
DBS Progamming From Atlas
n=1 Participants
DBS settings determined from the a functional atlas only,first
Change DBS programming: Patient will change thier settings to move from one group to the other to trial the other DBS settings
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=3 Participants
|
1 Participants
n=1 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=4 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
1 participants
n=1 Participants
|
4 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Data analysis was not completed because only one participant completed the DBS Programming from Atlas arm and disclosing data could violate privacy interests.
Tremor quantification
Outcome measures
Outcome data not reported
Adverse Events
DBS Programming, Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DBS Progamming From Atlas
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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