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Atlas Predicted DBS Settings in Essential Tremor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678429
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Fenna Phibbs, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE February 5, 2016
First Posted Date  ICMJE February 9, 2016
Last Update Posted Date May 28, 2020
Study Start Date  ICMJE September 2016
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
Fahn-Tolusa-Marsden tremor rating scale [ Time Frame: 1 month ]
Tremor quantification
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
Total Energy delivered [ Time Frame: 1 month ]
Summed DBS settings to determine total energy used
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atlas Predicted DBS Settings in Essential Tremor
Official Title  ICMJE Atlas Predicted DBS Settings in Essential Tremor
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Essential Tremor
Intervention  ICMJE Device: Change DBS programming
Patient will change thier settings to move from one group to the other to trial the other DBS settings
Study Arms  ICMJE
  • Active Comparator: DBS programming, standard of care
    DBS settings determined from the standard Neurologist symptomatic response, first
    Intervention: Device: Change DBS programming
  • Experimental: DBS progamming from Atlas
    DBS settings determined from the a functional atlas only,first
    Intervention: Device: Change DBS programming
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2020)
10
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2016)
30
Actual Study Completion Date  ICMJE February 2020
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02678429
Other Study ID Numbers  ICMJE 160155
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fenna Phibbs, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vanderbilt University Medical Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP