Interphase Gap in Biphasic Stimulation in DBS for ET

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-01-27

Brief Summary

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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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Detailed Description

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Conditions

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Essential Tremor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The patient will be allocated to the both arms in a cross-over design (no interphase gap and interphase gaps of different lenghts). The order of the pulses will be delivered in a random order, and with a double-blind design. Of all pulses, the therapeutic window will be assessed acutely (3 times per pulse shape).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Biphasic pulse without interphase gap

Group Type ACTIVE_COMPARATOR

Study Tool Computer

Intervention Type DEVICE

Nonconventional pulses delivered with custom-ware designed by Boston Scientific

Biphasic pulse with interphase gap

Group Type EXPERIMENTAL

Study Tool Computer

Intervention Type DEVICE

Nonconventional pulses delivered with custom-ware designed by Boston Scientific

Interventions

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Study Tool Computer

Nonconventional pulses delivered with custom-ware designed by Boston Scientific

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No