Back to resultsAtlas Predicted DBS Settings in Essential Tremor
Primary Purpose
Essential Tremor
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Change DBS programming
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor
Eligibility Criteria
Inclusion Criteria:
Seleced for DBS of the VIM nucleus at Vanderbilt Medical center Diagnosis of essential tremor
Exclusion Criteria:
Unable to use the patient handheld programmer
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
DBS programming, standard of care
DBS progamming from Atlas
Arm Description
DBS settings determined from the standard Neurologist symptomatic response first then change to settings from Atlas
DBS settings determined from the a functional atlas first then change to settings determined by standard of care
Outcomes
Primary Outcome Measures
Fahn-Tolusa-Marsden Tremor Rating Scale
Tremor quantification
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02678429
Brief Title
Atlas Predicted DBS Settings in Essential Tremor
Official Title
Atlas Predicted DBS Settings in Essential Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Unable to fully enroll no data analysis planned
Study Start Date
September 2016 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
November 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Programming Deep Brain Stimulation for the treatment of Essential Tremor can be a time intensive process. Using an atlas created using functional tremor responses in the operating room to determine the optimal settings would lead to a faster response for the patient and improved quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DBS programming, standard of care
Arm Type
Active Comparator
Arm Description
DBS settings determined from the standard Neurologist symptomatic response first then change to settings from Atlas
Arm Title
DBS progamming from Atlas
Arm Type
Experimental
Arm Description
DBS settings determined from the a functional atlas first then change to settings determined by standard of care
Intervention Type
Device
Intervention Name(s)
Change DBS programming
Intervention Description
Patient will change their DBS settings to move from one DBS setting to the other, allowed one hour to adjust to the new setting prior to testing
Primary Outcome Measure Information:
Title
Fahn-Tolusa-Marsden Tremor Rating Scale
Description
Tremor quantification
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Seleced for DBS of the VIM nucleus at Vanderbilt Medical center Diagnosis of essential tremor
Exclusion Criteria:
Unable to use the patient handheld programmer
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Atlas Predicted DBS Settings in Essential Tremor
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