Atlas Predicted DBS Settings in Essential Tremor

• ClinicalTrials.gov Identifier: NCT02678429
• Recruitment Status: Suspended
• First Posted: February 9, 2016
• Last Update Posted: November 30, 2020
• Sponsor: Vanderbilt University
• Information provided by (Responsible Party): Fenna Phibbs, Vanderbilt University

Tracking Information

• First Submitted Date: February 5, 2016
• First Posted Date: February 9, 2016
• Last Update Posted Date: November 30, 2020
• Actual Study Start Date: September 2016
• Estimated Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 8, 2016)

Fahn-Tolusa-Marsden tremor rating scale [ Time Frame: 1 month ]

Tremor quantification

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 8, 2016)

Total Energy delivered [ Time Frame: 1 month ]

Summed DBS settings to determine total energy used

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Atlas Predicted DBS Settings in Essential Tremor
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Essential Tremor

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Suspended
• Actual Enrollment (submitted: May 27, 2020): 10
• Original Estimated Enrollment (submitted: February 8, 2016): 30
• Estimated Study Completion Date: November 30, 2020
• Estimated Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02678429
• Other Study ID Numbers: 160155
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Fenna Phibbs, Vanderbilt University
• Study Sponsor: Vanderbilt University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Vanderbilt University Medical Center
• Verification Date: November 2020