Interphase Gap in Biphasic Stimulation in DBS for ET

Sponsor

Myles Mc Laughlin (Other)

Overall Status

Completed

CT.gov ID

NCT05177900

Collaborator

(none)

Enrollment

Location

Arms

1.9

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Tremor	Device: Study Tool Computer	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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).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).

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2021

Actual Primary Completion Date :

Jan 27, 2022

Actual Study Completion Date :

Jan 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Biphasic pulse without interphase gap	Device: Study Tool Computer Nonconventional pulses delivered with custom-ware designed by Boston Scientific
Experimental: Biphasic pulse with interphase gap	Device: Study Tool Computer Nonconventional pulses delivered with custom-ware designed by Boston Scientific

Arm

Intervention/Treatment

Active Comparator: Biphasic pulse without interphase gap

Device: Study Tool Computer

Nonconventional pulses delivered with custom-ware designed by Boston Scientific

Experimental: Biphasic pulse with interphase gap

Device: Study Tool Computer

Nonconventional pulses delivered with custom-ware designed by Boston Scientific

Outcome Measures

Primary Outcome Measures

Therapeutic threshold (mA) [During uptitration of the amplitude (entire process takes 3-4 minutes)]
Amplitude needed to elicit tremor arrest, expressed in milliamperes (mA)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

Myles Mc Laughlin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Myles Mc Laughlin, Assistant Professor, KU Leuven

ClinicalTrials.gov Identifier:

NCT05177900

Other Study ID Numbers:

s61020_IPG

First Posted:

Jan 5, 2022

Last Update Posted:

Apr 6, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Essential Tremor

Study Results

No Results Posted as of Apr 6, 2022