Algorithms for Programming DBS Systems for ET

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Deep brain stimulation (DBS) targeting the Vim thalamus (ventralis intermedius nucleus) is an FDA-approved neuromodulation therapy for treating postural and action tremor in individuals with essential tremor (ET). The success of this treatment, however, is highly dependent on the ability of clinicians to identify therapeutic stimulation settings through a laborious programming process. There is a strong and growing clinical need for new approaches to provide clinicians with more efficient guidance on how to titrate stimulation settings. This study will leverage subject-specific computational models that can predict neural activation of axonal pathways adjacent to the active electrode(s) and implicated in the therapeutic mechanisms of Vim-DBS to in turn guide clinicians with which stimulation settings are likely to be the most therapeutic on tremor.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• diagnosis of ET

• medication-refractory tremor

• VIM-DBS implant (unilateral or bilateral)

• 7T MRI pre-operative scan under Dr. Harel's IRB (institutional review board) protocol (#1210M22183)

• Post-operative CT scan

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Matthew Johnson, PhD
john5101@umn.edu
6126266492
Time Frame
Start Date: 2019-10-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 25
Treatments
Experimental: Deep Brain Stimulation
Subjects in this study will have been implanted with a DBS lead in the VIM as part of their routine clinical care and have an existing set of brain MRI's.
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov

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