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Device

Closed-Loop Deep Brain Stimulation for Essential Tremor

N/A

Waitlist Available

Led By Aysegul Gunduz, Ph.D

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

You are over 21 years of age.

You are diagnosed with a postural-intention (essential) tremor for at least 3 years and meet strict diagnostic criteria and have been seen and examined by a movement disorders fellowship trained neurologist.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post-surgery

Awards & highlights

Study Summary

This trial is testing a new, improved deep brain stimulator that only gives off pulses when the patient is actually experiencing tremors. The goal is to reduce side effects and improve quality of life for people with essential tremor.

Who is the study for?

This trial is for adults over 21 with severe essential tremor in the arms that hasn't improved after trying at least two medications, including propranolol or primidone. Participants must have had this condition for at least three years and be able to attend all study follow-ups. Pregnant individuals, those with substance abuse issues, major health problems, previous brain surgeries, Parkinsonian features, recent seizures or psychosis are not eligible.Check my eligibility

What is being tested?

The study tests a new 'closed-loop' deep brain stimulation device designed to treat arm tremors by delivering electrical impulses only when needed. This could reduce side effects compared to traditional continuous stimulation and extend battery life of the device.See study design

What are the potential side effects?

Potential side effects may include slurred speech and difficulty walking due to unnecessary current delivery from traditional deep brain stimulation devices; however, the closed-loop system aims to minimize these by providing targeted treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 21 years old.

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I have had essential tremor for over 3 years, diagnosed by a specialist.

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I have a severe hand tremor that hasn't improved with medication for over 3 months.

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My tremor in the limb I want treated scores at least 2 on a specific scale.

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My tremor hasn't improved after trying two medications, including propranolol or primidone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Rating Scale for Tremor (CRST) for closed-loop deep brain stimulation

Clinical Rating Scale for Tremor (CRST) for continuous deep brain stimulation

Trial Design

1Treatment groups

Experimental Treatment

Group I: Deep brain stimulationExperimental Treatment2 Interventions

All participants will undergo unilateral deep brain stimulation (DBS) implantation for essential tremor. Medtronic Summit RC+S devices will be used because these are capable of recording brain signals, as well as delivering DBS. Participants will receive continuous (open-loop) and closed-loop deep brain stimulation interventions, which will be compared for efficacy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deep brain stimulation

2010

Completed Phase 3

~380

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,676 Total Patients Enrolled

9 Trials studying Essential Tremor

439 Patients Enrolled for Essential Tremor

MedtronicIndustry Sponsor

605 Previous Clinical Trials

828,175 Total Patients Enrolled

5 Trials studying Essential Tremor

147 Patients Enrolled for Essential Tremor

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,339 Previous Clinical Trials

649,370 Total Patients Enrolled

21 Trials studying Essential Tremor

8,543 Patients Enrolled for Essential Tremor

Media Library

Closed-loop deep brain stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02649166 — N/A

Essential Tremor Research Study Groups: Deep brain stimulation

Essential Tremor Clinical Trial 2023: Closed-loop deep brain stimulation Highlights & Side Effects. Trial Name: NCT02649166 — N/A

Closed-loop deep brain stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02649166 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have taken part in the experiment thus far?

"Affirmative. The entry on clinicaltrials.gov suggests that this research is in need of participants, with the trial first posted on February 1st 2017 and most recently updated on September 21st 2022. 20 individuals are necessary for recruitment from one medical centre."

Answered by AI

Are recruitment efforts still underway for this experiment?

"As evidenced on clinicaltrials.gov, this research endeavour is presently recruiting participants. The trail was initially made available to the public on February 1st 2017 and has had its details modified as recently as September 21st 2022."

Answered by AI