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Device

Closed-Loop Deep Brain Stimulation for Essential Tremor

N/A

Waitlist Available

Led By Aysegul Gunduz, Ph.D

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

You are over 21 years of age.

You are diagnosed with a postural-intention (essential) tremor for at least 3 years and meet strict diagnostic criteria and have been seen and examined by a movement disorders fellowship trained neurologist.

Must not have

Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability.

Abnormal brain MRI including hydrocephalus, stroke, structural lesions, demyelinating lesions, or infectious lesions. Also excluded will be subjects with severe atrophy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new, improved deep brain stimulator that only gives off pulses when the patient is actually experiencing tremors. The goal is to reduce side effects and improve quality of life for people with essential tremor.

Who is the study for?

This trial is for adults over 21 with severe essential tremor in the arms that hasn't improved after trying at least two medications, including propranolol or primidone. Participants must have had this condition for at least three years and be able to attend all study follow-ups. Pregnant individuals, those with substance abuse issues, major health problems, previous brain surgeries, Parkinsonian features, recent seizures or psychosis are not eligible.

What is being tested?

The study tests a new 'closed-loop' deep brain stimulation device designed to treat arm tremors by delivering electrical impulses only when needed. This could reduce side effects compared to traditional continuous stimulation and extend battery life of the device.

What are the potential side effects?

Potential side effects may include slurred speech and difficulty walking due to unnecessary current delivery from traditional deep brain stimulation devices; however, the closed-loop system aims to minimize these by providing targeted treatment.

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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I have had essential tremor for over 3 years, diagnosed by a specialist.

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I have a severe hand tremor that hasn't improved with medication for over 3 months.

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My tremor in the limb I want treated scores at least 2 on a specific scale.

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My tremor hasn't improved after trying two medications, including propranolol or primidone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I may have symptoms like slow movement, stiffness, or balance problems.

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My brain MRI does not show severe issues like hydrocephalus, stroke, or severe atrophy.

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I have had brain surgery or treatments that target brain tissue.

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I do not have uncontrolled symptoms like headaches or nausea.

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I have had a seizure in the last year.

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I experience involuntary movements due to my medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-surgery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Clinical Rating Scale for Tremor (CRST) for closed-loop deep brain stimulation

Clinical Rating Scale for Tremor (CRST) for continuous deep brain stimulation

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 Treatment2 Interventions

All participants will undergo unilateral deep brain stimulation (DBS) implantation for essential tremor. Medtronic Summit RC+S devices will be used because these are capable of recording brain signals, as well as delivering DBS. Participants will receive continuous (open-loop) and closed-loop deep brain stimulation interventions, which will be compared for efficacy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deep brain stimulation

2010

Completed Phase 3

~390

0 / 11Eligibility criteria met