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Procedure

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
Must not have
Prior brain surgery
Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I have been diagnosed with Essential Tremor.
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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had brain surgery before.
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I may have symptoms similar to Parkinson's disease.
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I have a condition that affects how I move or walk.
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I have a significant neurological condition.
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I am taking medication that may cause shaking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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
Tremor Research Group Essential Tremor Rating Scale (TETRAS)
Secondary study objectives
Bain Tremor Disability Scale (BTDS)
Brief Ataxia Rating Scale (BARS)
Dot Approximation Task
+5 more

Awards & Highlights

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

Trial 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
~390

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,435 Previous Clinical Trials
1,621,640 Total Patients Enrolled
1 Trials studying Essential Tremor
25 Patients Enrolled for Essential Tremor
Jing Wang, PhDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
58 Total Patients Enrolled

Media Library

Coordinated Reset Deep Brain Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05897775 — Phase 1
Essential Tremor Research Study Groups: Clinically Optimized DBS Setting (T-DBS), Coordinated Reset DBS Setting (CR-DBS)
Essential Tremor Clinical Trial 2023: Coordinated Reset Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT05897775 — Phase 1
Coordinated Reset Deep Brain Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05897775 — Phase 1
~15 spots leftby Dec 2027
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