Interphase Gap in Biphasic Stimulation in DBS for ET

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05177900

Enrollment

Registered

2022-01-05

Start date

2021-12-01

Completion date

2022-01-27

Last updated

2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Tremor

Brief summary

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.

Interventions

DEVICEStudy Tool Computer

Nonconventional pulses delivered with custom-ware designed by Boston Scientific

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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).

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Side effect threshold (mA)	During uptitration of the amplitude (entire process takes 3-4 minutes)	Amplitude needed to elicit non-transient side effects, expressed in milliamperes (mA)
Therapeutic threshold (mA)	During uptitration of the amplitude (entire process takes 3-4 minutes)	Amplitude needed to elicit tremor arrest, expressed in milliamperes (mA)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026