Deep Brain Stimulation Effects in Essential Tremor

Essential Tremor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04581941
• Other study ID #: IRB202002623
• Status: Recruiting
• Start date: December 5, 2020
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: University of Florida
• Contact: Aysegul Gunduz, PhD
• Phone: 3522736877
• Email: agunduz[@]ufl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fahn- Tolosa- Marin Tremor Rating Scale	A clinical scale of tremor severity (0-4, 0:no symptoms, 4:extreme)	6 months