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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-months
Awards & highlights
Study 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 belowSelect...
I have been diagnosed with Essential Thrombocythemia (ET).
Select...
My tremor does not improve with medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-months
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 moreTrial 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.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,750 Total Patients Enrolled
1 Trials studying Essential Tremor
23 Patients Enrolled for Essential Tremor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Essential Thrombocythemia (ET).My tremor does not improve with medication.I have had brain surgery before, but not VIM-DBS surgery.You have had a VIM-DBS implant on one or both sides of your brain.I have had a CT scan after surgery.I have a condition that affects how my arms or legs move.You have another important brain or nerve condition.
Research Study Groups:
This trial has the following groups:- Group 1: Deep Brain Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals being actively sought to participate in this clinical research?
"Affirmative. Data on clinicaltrials.gov reveals that this medical trial initiated recruitment efforts in October 2019 and is still actively recruiting participants today, as last amended on August 1st 2022. The project necessitates 25 patients from a single site to participate."
Answered by AI
What is the intake quota for participants in this experiment?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, initiated on October 1st 2019, is currently recruiting patients. 25 participants are required at a single testing centre to fulfill the study's recruitment goals."
Answered by AI
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