Clinical trial NCT03811405: Physiology, Imaging and Modeling of Essential Tremor
Official title: Physiology, Imaging and Modeling of Deep Brain Stimulation for Essential Tremor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Essential Tremor
Parkinson Disease
Dystonia
Keywords: Deep Brain Stimulation (DBS)
ventralis intermedius nucleus (VIN)
implantable pulse generator (IPG)
Diffusion Tensor Imaging (DTI)
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Medtronic
First posted: 2019-01-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with chronically implanted DBS devices for ET who experience progressive worsening of tremor symptoms over time.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Volume of tissue activated from stimulation with ET DBS
timeFrame: up to 24 hours
measure: Baseline DBS settings versus active biphasic pulse DBS settings
timeFrame: up to 1 hour
Secondary outcomes:
measure: The Fahn-Tolosa-Marin Tremor Rating Scale
timeFrame: up to 15 minutes
measure: Tremor motor physiology
timeFrame: up to 15 minutes
measure: Gait impairment
timeFrame: up to 15 minutes
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
city: Gainesville
country: United States
facility: McKnight Brain Institute--Fixel Center for Neurological Diseases
state: Florida
Study officials:
affiliation: Univeristy of Florida
name: Leonardo B Almeida, MD
role: PRINCIPAL_INVESTIGATOR
References: