Brain Stimulation

Active biphasic pulse stimulation---VIN Biphasic for Essential Tremor

UF Health at the University of Florida, Gainesville, FL
Targeting 3 different conditionsActive biphasic pulse stimulation---VIN Biphasic +2 moreN/ARecruitingLed by Leonardo B Almeida, MDResearch Sponsored by University of Florida

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.

Eligible Conditions
  • Essential Tremor
  • Parkinson's Disease
  • Dystonia


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

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.

Find a site

Who is running the clinical trial?

University of FloridaLead Sponsor
1,288 Previous Clinical Trials
702,868 Total Patients Enrolled
9 Trials studying Essential Tremor
389 Patients Enrolled for Essential Tremor
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,297 Previous Clinical Trials
460,788 Total Patients Enrolled
20 Trials studying Essential Tremor
8,469 Patients Enrolled for Essential Tremor
MedtronicIndustry Sponsor
590 Previous Clinical Trials
820,719 Total Patients Enrolled
5 Trials studying Essential Tremor
97 Patients Enrolled for Essential Tremor
Leonardo B Almeida, MDPrincipal Investigator
Univeristy of Florida

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

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, 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 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
~17 spots leftby Jun 2024