Interphase Gap in Biphasic Stimulation in DBS for ET

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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study Tool Computer

Device

Nonconventional pulses delivered with custom-ware designed by Boston Scientific

Primary outcomes

Therapeutic threshold (mA)

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

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

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

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

Sponsors and collaborators

Lead sponsor

Myles Mc Laughlin

Other

Registry information

Official study title

Investigating the Use of an Interphase Gap in Biphasic Pulses in DBS for ET Patients

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jan 5, 2022
Registry last updated: Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed