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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am over 21 years old.
Select...
My tremor is moderate despite my deep brain stimulation therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy Assessment - Tremor
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
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,647 Total Patients Enrolled
9 Trials studying Essential Tremor
449 Patients Enrolled for Essential Tremor
MedtronicIndustry Sponsor
606 Previous Clinical Trials
828,655 Total Patients Enrolled
5 Trials studying Essential Tremor
157 Patients Enrolled for Essential Tremor
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,349 Total Patients Enrolled
21 Trials studying Essential Tremor
8,553 Patients Enrolled for Essential Tremor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I might have Parkinson's disease or show symptoms like slow movement, stiffness, or balance problems.I have a severe health condition that could affect my surgery tolerance.You have a serious untreated or unstable mood disorder, like depression.I have had a seizure in the last year.My tremor hasn't improved after trying two medications, including propranolol or primidone.I have a blood clotting disorder or take medication that affects blood clotting.My brain MRI does not show severe issues like stroke or major lesions.You have experienced or currently have a serious mental condition that affects your thoughts and emotions.Your score on a test for memory and thinking is less than 130, which means you may have trouble participating in the study tasks.I experience involuntary movements due to my medication.I do not have uncontrolled symptoms like headaches or nausea.I am over 21 years old.You have behaviors that show alcohol or substance abuse, as defined by a specific set of guidelines.You have difficulty with tasks like speaking, eating, and getting dressed even with ongoing VIM DBS therapy.I have had brain surgery before, but not for VIM DBS.I have had essential tremor for 3+ years and am treated with VIM DBS therapy.I have a severe hand tremor despite having VIM DBS therapy for over 3 months.My tremor is moderate despite my deep brain stimulation therapy.You have tried to harm yourself in the last six months.
Research Study Groups:
This trial has the following groups:- Group 1: Refractory Participants
- Group 2: Treatment Naive
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.
Is this research open to adults of a certain age or above?
"This clinical trial is currently enrolling patients aged 21-99 years old."
Answered by AI
What is the current population size of participants for this trial?
"Affirmative. The clinicaltrials.gov website suggests that this medical trial is still recruiting participants, with its initial post dating to December 24th 2019 and the most recent edit being June 28th 2022. 10 patients are needed from a single clinic location."
Answered by AI
Has enrollment for this trial opened yet?
"Affirmative. According to the records on clinicaltrials.gov, this medical research project is actively recruiting participants that meet its criteria; it was initially listed on December 24th 2019 and most recently updated on June 28th 2022. Specifically, 10 patients are required for just one site."
Answered by AI
To whom is the recruitment process for this trial available?
"For inclusion in this trial, subjects must have a family history of tremor and be between 21 to 99 years old. A total of 10 participants are needed for the study."
Answered by AI
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