Deep Brain Stimulation Effects in Essential Tremor

Deep Brain Stimulation Effects in Essential Tremor: Time Course of Electrophysiological Changes in Treatment

Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory essential tremor. However, DBS programming is not standardized and multiple clinic visits are frequently required to adequately control symptoms. The investigators aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. The investigators will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of DBS, and we will study the effects of DBS on these signals in order to guide clinical programming.

Study Overview

• Status: Recruiting
• Conditions: Essential Tremor

Detailed Description

The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. The is now the ability to stream brain signals from a newly FDA approved device, the Medtronic Percept. The investigators will study the longitudinal effects of DBS on the brain signals that are found to correlate with tremor severity as measured with wireless wearable sensors.

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Aysegul Gunduz, PhD; Phone Number: 3522736877; Email: agunduz@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • University of Florida
      • Contact: Aysegul Gunduz, PhD; Phone Number: 352-273-6877; Email: agunduz@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with essential tremor, who have been cleared for DBS surgery.

Description

Inclusion Criteria

• Patient gives an informed consent.
• Patient is over 21 years of age.
• Having a diagnosis of a essential tremor confirmed by a trained movement disorders neurologist;
• Having failed or not tolerated conventional medical management, at the discretion of the neurologist managing the patient;

Exclusion Criteria

• Having alternative diagnoses to essential tremor;
• Having comorbid neurodegenerative disorders that may affect mobility or cognition (e.g. comorbid Parkinson's disease or dystonia);
• Having sequelae of prior brain insult (e.g. prior stroke or brain tumor);
• History of prior resective brain surgery (e.g. tumor resection);
• Not being a DBS candidate;
• Receiving unilateral implants
• Having a higher surgical risk that precludes patient from having standard intraoperative mapping.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Patients with essential tremor; Patients with essential tremor who have clinically been deemed candidates for DBS (Deep Brain Stimulation) surgery. Deep brain stimulation is an FDA approved therapy that involves surgical implantation of electrodes in deep brain targets and an implantable pulse generator delivers electrical pulses. This intervention is not part of the study. The investigators are going to recruit patients who receive the Medtronic Percept device, which allows for brain signal recordings (this feature is FDA approved). The investigators will be conducting an observational study using this device to collect data that the subjects receive as standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fahn- Tolosa- Marin Tremor Rating Scale	A clinical scale of tremor severity (0-4, 0:no symptoms, 4:extreme)	6 months

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2020
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Tremor; Essential Tremor
• Other Study ID Numbers: IRB202002623

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No