Actively Recruiting
Algorithms for Programming Deep Brain Stimulation Systems for Essential Tremor
Led by University of Minnesota · Updated on 2026-01-27
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an approach to improve programming of deep brain stimulation (DBS) systems for people with essential tremor (ET), a condition causing postural and action tremors. This study focuses on using subject-specific computational models to predict brain pathways activated by DBS targeting the ventralis intermedius nucleus (Vim) of the thalamus. The goal is to help clinicians find the most effective stimulation settings more efficiently than the current laborious process. Participants already implanted with a DBS lead in the Vim as part of their routine care will be involved. The study will use advanced brain imaging techniques like 7-Tesla MRI and diffusion tensor imaging to build personalized neuron models. These models will guide a computational algorithm to identify optimal stimulation settings within FDA-approved safety limits. Settings will be tested during follow-up visits every six months for up to two years, comparing different target areas within the motor thalamus to find the most effective tremor suppression. During the study, participants will attend routine clinical follow-up sessions where clinicians will evaluate the effects of the DBS settings using the Essential Tremor Rating Assessment Scale (TETRAS) and quality of life questionnaires. Outcome measures include therapeutic window size, objective tremor assessments, and quality of life at 24 months. Researchers will monitor safety and treatment effectiveness throughout, ensuring stimulation remains within approved limits while assessing improvements in tremor control and participant well-being.
CONDITIONS
Brief Title
Algorithms for Programming DBS Systems for ET
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of essential tremor
- Tremor that does not respond to medication
- Implanted DBS lead in the ventralis intermedius nucleus (VIM), unilateral or bilateral
- Pre-operative 7-Tesla MRI scan under Dr. Harel's IRB protocol (#1210M22183)
- Post-operative CT scan
You will not qualify if you...
- History of musculoskeletal disorders affecting limb movement
- Other significant neurological disorders
- Prior stereotactic neurosurgery other than VIM-DBS surgery
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants have an implanted DBS lead in the VIM as part of their routine clinical care and undergo testing of model-derived DBS settings during clinical visits.
Clinical visits every 6 months
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
M
Matthew Johnson, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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