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Deep Brain Stimulation for Essential Tremor
Phase 1
Recruiting
Led By Jing Wang, PhD
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 Essential Tremor (ET)
Age of 21 or over
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
This trial will study a novel approach to Deep Brain Stimulation to treat Essential Tremor in the upper extremity, to evaluate its safety and short-term efficacy.
Who is the study for?
This trial is for adults over 21 with Essential Tremor (ET) affecting their upper extremities, who will have a Boston Scientific Vercise Rechargeable Genus DBS system implanted and can undergo specific MRI scans. It's not suitable for those with other central nervous system diseases, musculoskeletal or significant neurological disorders, cognitive impairments, psychiatric diseases, tremors caused by medication, prior brain surgery or Parkinsonian features.Check my eligibility
What is being tested?
The study tests a new type of Deep Brain Stimulation called coordinated reset DBS (CR-DBS), which uses varied stimulation patterns at lower currents to potentially improve Essential Tremor symptoms in the arms. The effects during and after treatment are compared to traditional high-frequency DBS.See study design
What are the potential side effects?
While side effects aren't detailed here, typical risks of deep brain stimulation may include headache, infection risk at the implant site, speech problems and balance issues. Specific side effects related to CR-DBS will be monitored given its novel approach.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Essential Tremor.
Select...
I am 21 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tremor Research Group Essential Tremor Rating Scale (TETRAS)
Secondary outcome measures
Bain Tremor Disability Scale (BTDS)
Brief Ataxia Rating Scale (BARS)
Dot Approximation Task
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Coordinated Reset DBS Setting (CR-DBS)Experimental Treatment1 Intervention
Coordinated Reset DBS settings
Group II: Clinically Optimized DBS Setting (T-DBS)Experimental Treatment1 Intervention
Traditional DBS settings
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep brain stimulation
2010
Completed Phase 3
~380
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,952 Total Patients Enrolled
1 Trials studying Essential Tremor
25 Patients Enrolled for Essential Tremor
Jing Wang, PhDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
59 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had brain surgery before.I may have symptoms similar to Parkinson's disease.I have been diagnosed with Essential Tremor.I have a condition that affects how I move or walk.I am scheduled for a CT scan after surgery.I have a significant neurological condition.You have a history of memory problems or trouble thinking clearly.You have a serious mental health condition.I am 21 years old or older.I am taking medication that may cause shaking.This criterion means that individuals who have had a specific type of MRI scan at a certain facility will be excluded from the study.I have had a brain condition or injury for at least 3 months.You have another serious health condition that could make it hard for you to take part in the study.You are going to receive a specific type of deep brain stimulation system called the Boston Scientific Vercise Rechargeable Genus.
Research Study Groups:
This trial has the following groups:- Group 1: Clinically Optimized DBS Setting (T-DBS)
- Group 2: Coordinated Reset DBS Setting (CR-DBS)
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 there currently an effort to enlist participants in this research initiative?
"The clinicaltrials.gov portal reveals that this medical trial is not actively recruiting any more; it was first posted on July 1st 2023 and last edited June 1st of the same year. However, 55 other trials are currently accepting candidates."
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