Interphase Gap in Biphasic Stimulation in DBS for ET

Myles Mc Laughlin9 enrolled

Overview

Deep Brain Stimulation (DBS) is a well established therapy in medication-refractory essential tremor (ET). Since the inception of DBS, cathodic pulses are used. Recent work suggests that biphasic pulses influence the therapeutic window when compared to cathodic pulses, when tested acutely. Animal studies and work from cochlear implants, show that the use of an interphase gap, influences the generation of action potentials. In this study, the goal is to investigate the use of an interphase gap in biphasic pulses in DBS for ET patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Essential Tremor

Interventions

Study Tool ComputerDEVICE

Nonconventional pulses delivered with custom-ware designed by Boston Scientific

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with essential tremor treated with Vim-DBS * Normal impedances of DBS circuit * Signed written informed consent Exclusion Criteria: * Active psychiatric disease or active alcohol or drug abuse * Dementia * History of recurrent or unprovoked seizures * Relevant comorbidities that influence objective clinical assessment * Pregnancy

Locations (1)

UZ Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Therapeutic threshold (mA)

Amplitude needed to elicit tremor arrest, expressed in milliamperes (mA)

Time frame: During uptitration of the amplitude (entire process takes 3-4 minutes)

Side effect threshold (mA)

Amplitude needed to elicit non-transient side effects, expressed in milliamperes (mA)

Time frame: During uptitration of the amplitude (entire process takes 3-4 minutes)

Data from ClinicalTrials.gov

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