Your session is about to expire
← Back to Search
Brain Stimulation
Brain Stimulation for Essential Tremor
N/A
Recruiting
Led By Leonardo B Almeida, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours
Awards & highlights
Study Summary
This trial will test whether changes to software in existing brain stimulation devices can help ET patients. The team will look at safety and effectiveness of the new stimulation parameters.
Who is the study for?
This trial is for people with Essential Tremor who already have a brain stimulation device implanted. They should be mentally sharp (with an MMSE score over 24) and have noticed their tremor control isn't as good as it was after surgery, even on two different check-ups.Check my eligibility
What is being tested?
The study tests new software settings for the brain stimulation devices in ET patients to see if they can better control tremors. Participants will try three modes: active stimulation at home, active VIN Biphasic stimulation, and periods with the stimulator turned off.See study design
What are the potential side effects?
While specific side effects aren't listed, changes in brain stimulation may cause discomfort, headache, dizziness or worsening of tremors temporarily. The safety of these new settings is a key part of what's being studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Baseline DBS settings versus active biphasic pulse DBS settings
Volume of tissue activated from stimulation with ET DBS
Secondary outcome measures
Gait impairment
The Fahn-Tolosa-Marin Tremor Rating Scale
Tremor motor physiology
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with Essential TremorExperimental Treatment3 Interventions
Patients with chronically implanted DBS devices for ET who experience progressive worsening of tremor symptoms over time. The DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation. The following random conditions will be applied: (1) Home Settings; (2) VIN Biphasic; (3) Stimulator Off. A 30-minute washout period will be applied between each of the random conditions. Therefore, each patient will serve as their own control.
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,576 Total Patients Enrolled
9 Trials studying Essential Tremor
389 Patients Enrolled for Essential Tremor
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
649,319 Total Patients Enrolled
21 Trials studying Essential Tremor
8,493 Patients Enrolled for Essential Tremor
MedtronicIndustry Sponsor
607 Previous Clinical Trials
828,605 Total Patients Enrolled
5 Trials studying Essential Tremor
97 Patients Enrolled for Essential Tremor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been diagnosed with Essential Tremor.You have undergone deep brain stimulation surgery for essential tremor, and your tremors have not improved as expected after the surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with Essential Tremor
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.
Could I potentially meet the criteria to participate in this medical research?
"To be accepted into the trial, patients must have been diagnosed with dystonia and fall between 18-80 years of age. In total, 70 individuals will have their applications considered."
Answered by AI
Is there an age cap on eligibility for this research initiative?
"This research initiative is looking for participants aged 18 and above but below the age of 80."
Answered by AI
How many participants are involved in this trial?
"That's correct. Per data on clinicaltrials.gov, this study is currently enlisting participants, with the first post date being April 1st 2021 and last update occurring February 1st 2022. The trial needs to recruit 70 patients from 2 medical sites."
Answered by AI
Are there any openings for participants in this medical experiment?
"Affirmative, the information found on clinicaltrials.gov confirms that this trial is actively seeking enrolment. The initial posting was dated April 1st 2021 and it has since been updated February 1st 2022; 70 participants are needed from two locations."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger