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Atlas Predicted DBS Settings in Essential Tremor

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ClinicalTrials.gov Identifier: NCT02678429
Recruitment Status : Active, not recruiting
First Posted : February 9, 2016
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Fenna Phibbs, Vanderbilt University

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
Essential Tremor Device: Change DBS programming Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Atlas Predicted DBS Settings in Essential Tremor
Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

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




Primary Outcome Measures :
  1. Fahn-Tolusa-Marsden tremor rating scale [ Time Frame: 1 month ]
    Tremor quantification


Secondary Outcome Measures :
  1. Total Energy delivered [ Time Frame: 1 month ]
    Summed DBS settings to determine total energy used



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678429


Locations
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United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University

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Responsible Party: Fenna Phibbs, Assistant Professor of Neurology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02678429     History of Changes
Other Study ID Numbers: 160155
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases