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Neuromodulation Therapy

Deep Brain Stimulation for Essential Tremor

N/A
Recruiting
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of ET
Medication-refractory tremor
Must not have
Prior history of stereotactic neurosurgery (other than VIM-DBS surgery)
History of musculoskeletal disorders that affect movement of the limbs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-months
Awards & highlights

Summary

This trial will use subject-specific computational models to guide clinicians in choosing stimulation settings for deep brain stimulation targeting the Vim thalamus, an FDA-approved neuromodulation therapy for treating postural and action tremor in individuals with essential tremor.

Who is the study for?
This trial is for individuals with Essential Tremor (ET) who haven't responded well to medications and have a Vim-Deep Brain Stimulation (DBS) implant. Participants must have had a specific type of MRI scan before surgery and a CT scan after. It's not for those with limb movement disorders, other major neurological conditions, previous brain surgeries besides VIM-DBS, or pregnant women.Check my eligibility
What is being tested?
The study tests new algorithms to program DBS systems more efficiently in patients with ET. By using computational models that predict neural activation near the implanted electrode, it aims to help clinicians quickly find the best settings to control tremors.See study design
What are the potential side effects?
While side effects are not detailed here, typical risks of DBS can include headache, confusion, balance issues, and temporary swelling at the implant site. The programming process itself is non-invasive but adjustments may cause varying sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Essential Thrombocythemia (ET).
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My tremor does not improve with medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had brain surgery before, but not VIM-DBS surgery.
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I have a condition that affects how my arms or legs move.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Measures of Tremor
Quality of Life Questionnaire: QUEST
Quality of Life Questionnaire: TETRAS
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep Brain StimulationExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,395 Previous Clinical Trials
1,553,300 Total Patients Enrolled
1 Trials studying Essential Tremor
23 Patients Enrolled for Essential Tremor

Media Library

Vim-Deep Brain Stimulation (Neuromodulation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03984643 — N/A
Essential Tremor Research Study Groups: Deep Brain Stimulation
Essential Tremor Clinical Trial 2023: Vim-Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT03984643 — N/A
Vim-Deep Brain Stimulation (Neuromodulation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03984643 — N/A
~2 spots leftby Dec 2024