Interphase Gap in Biphasic Stimulation in DBS for ET

Myles Mc Laughlin

Status: Completed

Conditions: Essential Tremor

Treatments: Device: Study Tool Computer

Study type: Interventional

Funder types: Other

Identifiers

NCT05177900

s61020_IPG

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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9 participants in 2 patient groups

Biphasic pulse without interphase gap

Active Comparator group

Treatment:

Device: Study Tool Computer

Biphasic pulse with interphase gap

Experimental group

Treatment:

Device: Study Tool Computer