← Back to Search
Device
Closed-Loop Deep Brain Stimulation for Essential Tremor
Gainesville, FL
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.
See full description
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.Check my eligibility
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.See study design
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 belowSelect...
I am over 21 years old.
show original
Select...
I have had essential tremor for over 3 years, diagnosed by a specialist.
show original
Select...
I have a severe hand tremor that hasn't improved with medication for over 3 months.
show original
Select...
My tremor in the limb I want treated scores at least 2 on a specific scale.
show original
Select...
My tremor hasn't improved after trying two medications, including propranolol or primidone.
show original
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I may have symptoms like slow movement, stiffness, or balance problems.
show original
Select...
My brain MRI does not show severe issues like hydrocephalus, stroke, or severe atrophy.
show original
Select...
I have had brain surgery or treatments that target brain tissue.
show original
Select...
I do not have uncontrolled symptoms like headaches or nausea.
show original
Select...
I have had a seizure in the last year.
show original
Select...
I experience involuntary movements due to my medication.
show original
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post-surgery
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
Find a Location
Closest Location:University of Florida· Gainesville, FL· 715 miles
Who is running the clinical trial?
University of FloridaLead Sponsor
1,425 Previous Clinical Trials
986,726 Total Patients Enrolled
9 Trials studying Essential Tremor
428 Patients Enrolled for Essential Tremor
MedtronicIndustry Sponsor
626 Previous Clinical Trials
766,856 Total Patients Enrolled
5 Trials studying Essential Tremor
147 Patients Enrolled for Essential Tremor
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,400 Previous Clinical Trials
656,156 Total Patients Enrolled
21 Trials studying Essential Tremor
8,543 Patients Enrolled for Essential Tremor
Aysegul Gunduz, Ph.DPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced difficulty with speaking, eating, drinking, personal hygiene, dressing, writing, working, or social activities, as measured by a specific scoring system.I may have symptoms like slow movement, stiffness, or balance problems.You have a history of alcohol or drug abuse as outlined in the DSM-V.I have a severe health condition that could affect my surgery.My brain MRI does not show severe issues like hydrocephalus, stroke, or severe atrophy.You have significant cognitive problems, which might make it hard for you to do the study tasks.You have tried to harm yourself or have wanted to do so in the last six months.I do not have uncontrolled symptoms like headaches or nausea.I have had a seizure in the last year.I have a significant mood disorder or depression.I am over 21 years old.I have had essential tremor for over 3 years, diagnosed by a specialist.I have a severe hand tremor that hasn't improved with medication for over 3 months.My tremor in the limb I want treated scores at least 2 on a specific scale.I have had brain surgery or treatments that target brain tissue.My tremor hasn't improved after trying two medications, including propranolol or primidone.I experience involuntary movements due to my medication.You have experienced or currently have severe mental health issues such as hallucinations or delusions.
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.