Atlas Predicted DBS Settings in Essential Tremor
Sponsor
Vanderbilt University (Other)
Overall Status
Terminated
CT.gov ID
NCT02678429
Collaborator
(none)
10
1
2
62.6
0.2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Atlas Predicted DBS Settings in Essential Tremor
Actual Study Start Date
:
Sep 1, 2016
Actual Primary Completion Date
:
Nov 19, 2021
Actual Study Completion Date
:
Nov 19, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: DBS programming, standard of care DBS settings determined from the standard Neurologist symptomatic response, first |
Device: Change DBS programming
Patient will change thier settings to move from one group to the other to trial the other DBS settings
|
| Experimental: DBS progamming from Atlas DBS settings determined from the a functional atlas only,first |
Device: Change DBS programming
Patient will change thier settings to move from one group to the other to trial the other DBS settings
|
Outcome Measures
Primary Outcome Measures
- Fahn-Tolusa-Marsden tremor rating scale [1 month]
Tremor quantification
Secondary Outcome Measures
- Total Energy delivered [1 month]
Summed DBS settings to determine total energy used
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vanderbilt University | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Vanderbilt University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fenna Phibbs,
Assistant Professor of Neurology,
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT02678429
Other Study ID Numbers:
- 160155
First Posted:
Feb 9, 2016
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021