RECRUITING

Algorithms for Programming DBS Systems for ET

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Algorithms for Programming DBS Systems for ET

Quick Facts

Study Start:2019-10-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03984643

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * diagnosis of ET
  2. * medication-refractory tremor
  3. * VIM-DBS implant (unilateral or bilateral)
  4. * 7T MRI pre-operative scan under Dr. Harel's IRB (institutional review board) protocol (#1210M22183)
  5. * Post-operative CT scan
  1. * history of musculoskeletal disorders that affect movement of the limbs
  2. * other significant neurological disorder
  3. * prior history of stereotactic neurosurgery (other than VIM-DBS surgery)
  4. * pregnancy

Contacts and Locations

Study Contact

Matthew Johnson, PhD
CONTACT
6126266492
john5101@umn.edu

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-10-01
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Essential Tremor