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Device

Directional vs. Nondirectional DBS for Essential Tremor

N/A
Waitlist Available
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A tremor syndrome of bilateral upper limb action tremor with at least 3 years' duration
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will test if a new type of deep brain stimulation is more effective at treating essential tremor while minimizing side effects.

Who is the study for?
This trial is for people with essential tremor in both arms lasting over 3 years, who haven't had relief from other treatments and are considering deep brain stimulation (DBS). It's not for those with tremors due to drugs or other neurological conditions, nor for patients with a history of DBS or thalamotomy, pacemakers, or certain medical procedures.Check my eligibility
What is being tested?
The study at OHSU is testing if directional DBS provides better control of essential tremor compared to nondirectional DBS. The goal is to see if it can treat the tremor more effectively while reducing unwanted effects on speech, walking and balance.See study design
What are the potential side effects?
While not specified here, common side effects of DBS may include headache, confusion, difficulty speaking, balance problems and tingling sensations. These vary by individual and should be discussed with the healthcare team.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been experiencing shaking in both of your arms for at least 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic window
Secondary outcome measures
Compare the effects of directional versus nondirectional DBS on balance and gait
Compare the effects of directional versus nondirectional DBS on perceptual assessment of voice and speech
Compare the effects of directional versus nondirectional DBS on self perception of speech
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Directional deep brain stimulationActive Control1 Intervention
Deep brain stimulation delivered in a directional manner within an axial plane
Group II: Nondirectional deep brain stimulationActive Control1 Intervention
Deep brain stimulation delivered in a nondirectional manner within an axial plane

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
6,846,005 Total Patients Enrolled
2 Trials studying Essential Tremor
28 Patients Enrolled for Essential Tremor

Media Library

Deep brain stimulation of the VIM Thalamic nuclei (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04828798 — N/A
Essential Tremor Research Study Groups: Directional deep brain stimulation, Nondirectional deep brain stimulation
Essential Tremor Clinical Trial 2023: Deep brain stimulation of the VIM Thalamic nuclei Highlights & Side Effects. Trial Name: NCT04828798 — N/A
Deep brain stimulation of the VIM Thalamic nuclei (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04828798 — N/A
Essential Tremor Patient Testimony for trial: Trial Name: NCT04828798 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being enrolled for this research endeavor?

"According to clinicaltrials.gov, the search for participants is still underway. This medical study was initially posted on April 1st 2021 and has since undergone revisions culminating in its most recent update on March 30th of this year."

Answered by AI

Who has the permission to take part in this clinical research?

"This medical trial is searching for 24 individuals aged 18-80 that have a hereditary tremor. To be eligible, applicants must have experienced bilaterally symmetrical upper limb quivering with an onset at least 3 years ago."

Answered by AI

What is the enrollment capacity of this medical research?

"Affirmative. Clinicaltrials.gov's records demonstrate that this medical trial, first published on April 1st 2021, is still recruiting patients. 24 individuals are required to be enrolled at a single site for the study to reach completion."

Answered by AI

Does the study include individuals who are over thirty-five years old?

"This research seeks individuals aged 18 to 80, with a separate clinical trial targeting minors and another specifically for elderly patients over 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What site did they apply to?
Oregon Health & Science University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am currently on 20 MG Propranolo in the morning and 24 hr 60 MG at night.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Directional Versus Nondirectional DBS for ET
Matthew Brodsky 2021. "Directional Versus Nondirectional DBS for ET". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04828798.
All > Dbs
~6 spots leftby Apr 2025
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