Deep Brain Stimulation Effects in Essential Tremor

NCT04581941 | Completed

• 1 other identifier: IRB202002623
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

• Fahn- Tolosa- Marin Tremor Rating Scale

  A clinical scale of tremor severity (0-4, 0:no symptoms, 4:extreme)

  6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 9, 2020
• Study Start: December 5, 2020
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

US (1)