Interphase Gap in Biphasic Stimulation in DBS for ET

Essential Tremor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05177900
• Other study ID #: s61020_IPG
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: January 27, 2022

Study information

• Verified date: April 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 27, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor

Intervention

Device:
• Study Tool Computer
Nonconventional pulses delivered with custom-ware designed by Boston Scientific

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Myles Mc Laughlin

Country where clinical trial is conducted

Belgium, 

Outcome

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