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Deep Brain Stimulation

DBS System for Essential Tremor

N/A
Recruiting
Led By Karin Oweiss, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is over 21 years of age
Patient has a postural or kinetic tremor severity score of at least 2 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor (TRS) despite ongoing VIM DBS therapy
Must not have
Any suspicion of Parkinson's disease, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability
A history of seizures within the past year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a new DBS system can help control essential tremor. If successful, the data will be used to try and get FDA approval for the system.

Who is the study for?
This trial is for adults over 21 with severe essential tremor that hasn't improved after trying at least two medications and ongoing traditional VIM DBS therapy. Participants must have a specific level of disability due to the tremor, be able to follow up throughout the study, and not have other central nervous system diseases or significant medical conditions.
What is being tested?
The study tests new dual lead thalamic DBS systems for controlling severe essential tremors in patients where current treatments aren't enough. It's an early-stage trial to see if this approach works well enough to plan larger trials aimed at FDA approval for these advanced DBS systems.
What are the potential side effects?
While not explicitly listed, potential side effects may include those typical of deep brain stimulation surgery such as headache, nausea, bleeding in the brain, infection risk from implanted hardware, and possible changes in mood or cognition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 21 years old.
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My tremor is moderate despite my deep brain stimulation therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I might have Parkinson's disease or show symptoms like slow movement, stiffness, or balance problems.
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I have had a seizure in the last year.
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I have a blood clotting disorder or take medication that affects blood clotting.
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My brain MRI does not show severe issues like stroke or major lesions.
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I experience involuntary movements due to my medication.
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I do not have uncontrolled symptoms like headaches or nausea.
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I have had brain surgery before, but not for VIM DBS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Efficacy Assessment - Tremor

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Refractory ParticipantsActive Control2 Interventions
Patients with recurrent, debilitating intention tremor despite ongoing, optimized VIM DBS therapy
Group II: Treatment NaiveActive Control3 Interventions
Participants receiving Long-term stimulation of the thalamus via dual leads for Essential Tremor

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,409 Previous Clinical Trials
767,449 Total Patients Enrolled
9 Trials studying Essential Tremor
438 Patients Enrolled for Essential Tremor
MedtronicIndustry Sponsor
619 Previous Clinical Trials
764,078 Total Patients Enrolled
5 Trials studying Essential Tremor
157 Patients Enrolled for Essential Tremor
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,385 Previous Clinical Trials
652,678 Total Patients Enrolled
21 Trials studying Essential Tremor
8,553 Patients Enrolled for Essential Tremor
Karin Oweiss, PhDPrincipal InvestigatorUniversity of Florida
Karim Oweiss, PhDPrincipal InvestigatorUniversity of Florida

Media Library

ipsilateral thalamic (VIM+VO) DBS (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04212780 — N/A
Essential Tremor Research Study Groups: Refractory Participants, Treatment Naive
Essential Tremor Clinical Trial 2023: ipsilateral thalamic (VIM+VO) DBS Highlights & Side Effects. Trial Name: NCT04212780 — N/A
ipsilateral thalamic (VIM+VO) DBS (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04212780 — N/A
~2 spots leftby Dec 2025
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