Physiology, Imaging and Modeling of Essential Tremor

Parkinson Disease Clinical Trial

Official title:

Physiology, Imaging and Modeling of Deep Brain Stimulation for Essential Tremor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03811405
• Other study ID #: IRB201802397 -N -A
• Secondary ID: OCR196075R25NS10
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: Leonardo B Almeida, MD
• Phone: (352) 294-5400
• Email: Leonardo.BritodeAlmeida[@]neurology.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Deep brain stimulation (DBS) is a neuromodulatory therapy that is effective in a subset of well selected essential tremor (ET) patients. However, as many as 1/5 of patients may initially improve, but then steadily worsen following the operation. The investigators developed a technique to study a variety of alternative stimulation methods without the use of an invasive repeat surgical intervention.

The electrophysiological effects of non-conventional DBS differ from traditional DBS, however the physiological differences in the setting of human tremor remain largely unknown. This study plans to explore gaps in knowledge of neuromodulation and will collect and contribute essential information to the underlying mechanism of action of DBS. The hypothesis of this project centers around active biphasic stimulation providing a wider therapeutic window and a lower adverse event profile as compared to conventional DBS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• No diagnosis of Essential Tremor

Related Conditions & MeSH terms

• Dystonia
• Essential Tremor
• Parkinson Disease
• Tremor

Intervention

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

Locations

Country	Name	City	State
United States	McKnight Brain Institute--Fixel Center for Neurological Diseases	Gainesville	Florida
United States	UF Health at the University of Florida	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	Medtronic, National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The Fahn-Tolosa-Marin Tremor Rating Scale	Essential tremor severity will be assessed by the clinically validated Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS). It is a 0 to 4 scale (0 = no tremor; 4 = severe amplitude of tremor) of 9 different parts of the body. The FTMTRS will be assessed for the various DBS settings.	up to 15 minutes
Secondary	Tremor motor physiology	Essential tremor motor physiology will be recorded by the Kinesia ONE accelerometer system. THe Kinesia ONE system is a wireless wearable motion sensor unit and portable transducer that translates the degree of movement into a standardized scale. Tremor physiology will be assessed for the various DBS settings.	up to 15 minutes
Secondary	Gait impairment	Essential tremor's effect on gait will be assessed by the GAITRite system. Patients will walk along a GAITRite floor mat to have the various gait parameters such as step time, cycle time, step length, stride length, etc measured. Gait parameters will be assessed on the various DBS settings.	up to 15 minutes