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

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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 24 hours

Awards & highlights

No Placebo-Only Group

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

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

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.

Do I qualify?Apply below to find out

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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 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

clinicaltrials.govStudy

Physiology, Imaging and Modeling of Essential Tremor

2021. "Physiology, Imaging and Modeling of Essential Tremor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03811405.