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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Measures of Tremor

Quality of Life Questionnaire: QUEST

Quality of Life Questionnaire: TETRAS

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met