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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
Must not have
No diagnosis of Essential Tremor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours
Awards & highlights

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not been diagnosed with Essential Tremor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours for reporting.

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
1,354 Previous Clinical Trials
713,276 Total Patients Enrolled
9 Trials studying Essential Tremor
389 Patients Enrolled for Essential Tremor
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,349 Previous Clinical Trials
648,107 Total Patients Enrolled
21 Trials studying Essential Tremor
8,493 Patients Enrolled for Essential Tremor
MedtronicIndustry Sponsor
611 Previous Clinical Trials
828,819 Total Patients Enrolled
5 Trials studying Essential Tremor
97 Patients Enrolled for Essential Tremor

Media Library

Active biphasic pulse stimulation---Home Settings (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03811405 — N/A
Essential Tremor Research Study Groups: Patients with Essential Tremor
Essential Tremor Clinical Trial 2023: Active biphasic pulse stimulation---Home Settings Highlights & Side Effects. Trial Name: NCT03811405 — N/A
Active biphasic pulse stimulation---Home Settings (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03811405 — N/A
~15 spots leftby Jun 2025