Interphase Gap in Biphasic Stimulation in DBS for ET

NCT05177900 | Completed DMC

• 1 other identifier: s61020_IPG
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (2)

• Therapeutic threshold (mA)

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

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

• 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)

Study Arms (2)

Biphasic pulse without interphase gap

ACTIVE COMPARATOR

Device: Study Tool Computer

Biphasic pulse with interphase gap

EXPERIMENTAL

Device: Study Tool Computer

Interventions

Study Tool Computer DEVICE

Nonconventional pulses delivered with custom-ware designed by Boston Scientific

Biphasic pulse with interphase gap; Biphasic pulse without interphase gap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with essential tremor treated with Vim-DBS
• Normal impedances of DBS circuit
• Signed written informed consent

You may not qualify if:

• Active psychiatric disease or active alcohol or drug abuse
• Dementia
• History of recurrent or unprovoked seizures
• Relevant comorbidities that influence objective clinical assessment
• Pregnancy

Sponsors & Collaborators

• Myles Mc Laughlin: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Boogers A, Peeters J, Van Bogaert T, De Vloo P, Vandenberghe W, Nuttin B, Mc Laughlin M. Interphase Gaps in Symmetric Biphasic Pulses Reduce the Therapeutic Window in Ventral Intermediate Nucleus of the Thalamus-Deep Brain Stimulation for Essential Tremor. Neuromodulation. 2023 Dec;26(8):1699-1704. doi: 10.1016/j.neurom.2022.09.012. Epub 2022 Nov 18.

  PMID: 36404213 DERIVED

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 5, 2022
• Study Start: December 1, 2021
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)