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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Baseline DBS settings versus active biphasic pulse DBS settings

Volume of tissue activated from stimulation with ET DBS

Secondary study objectives

Gait impairment

The Fahn-Tolosa-Marin Tremor Rating Scale

Tremor motor physiology

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met