Physiology, Imaging and Modeling of Essential Tremor

NCT03811405 | Completed FDA Device

• 4 other identifiers: IRB201802397 -N -AOCR196075R25NS108939-04MEDTRONIC INC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

This project aims to investigate novel ways to deliver brain stimulation to Essential Tremor (ET) patients by introducing software changes to their existing devices. The study team aims to investigate safety and efficacy of these new stimulation parameters in patients with ET.

Conditions

Essential Tremor; Parkinson Disease; Dystonia

Keywords

Deep Brain Stimulation (DBS); ventralis intermedius nucleus (VIN); implantable pulse generator (IPG); Diffusion Tensor Imaging (DTI)

Outcome Measures

Primary Outcomes (2)

• Volume of tissue activated from stimulation with ET DBS

  The study team will use computer simulation and virtual reconstruction of the brain from pre-operative MRI data to calculate the volume of tissue activated (VTA) from the novel stimulation patterns. The investigators will assess the feasibility of the patterns to address the worsening of ET that may occur in 20% or more of the ET population.

  up to 24 hours

• Baseline DBS settings versus active biphasic pulse DBS settings

  The investigators will compare the degree of tremor suppression from the most optimal DBS settings that can be obtained via traditional programming methods versus active biphasic DBS. The degree of tremor will be quantified by multiple clinical metrics including the Fahn-Tolosa-Marin Tremor Rating Scale and Kinesia ONE® accelerometer system.

  up to 1 hour

Secondary Outcomes (3)

• The Fahn-Tolosa-Marin Tremor Rating Scale

  up to 15 minutes

• Tremor motor physiology

  up to 15 minutes

• Gait impairment

  up to 15 minutes

Study Arms (1)

Patients with Essential Tremor

EXPERIMENTAL

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.

Device: Active biphasic pulse stimulation---Home Settings; Device: Active biphasic pulse stimulation---VIN Biphasic; Device: Active biphasic pulse stimulation---Stimulator Off

Interventions

Active biphasic pulse stimulation---Home Settings DEVICE

During this visit, the DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation.

Patients with Essential Tremor

Active biphasic pulse stimulation---VIN Biphasic DEVICE

During this visit, the DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation.

Patients with Essential Tremor

Active biphasic pulse stimulation---Stimulator Off DEVICE

During this visit, the DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation.

Patients with Essential Tremor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Existing unilateral or bilateral VIN DBS for ET, non-demented (MMSE\>24), and must have a documented suboptimal tremor suppression on two successive visits (compared to the baseline post-operative improvement at 6 months following ET DBS surgery). For bilateral cases, the most affected tremor side will be studied.

You may not qualify if:

• No diagnosis of Essential Tremor

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Medtronic: collaborator

Study Sites (2)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

McKnight Brain Institute--Fixel Center for Neurological Diseases

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Essential Tremor; Parkinson Disease; Dystonia

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joshua K Wong, MD

  Univeristy of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Each of the 3 interventions will be videotaped for blinded motor score assessment by an independent rater.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with chronically implanted DBS devices for ET who experience progressive worsening of tremor symptoms over time.

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 22, 2019
• Study Start: April 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

US (2)