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Interphase Gap in Biphasic Stimulation in DBS for ET

Primary Purpose

Essential Tremor

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Study Tool Computer

About this trial

This is an interventional treatment trial for Essential Tremor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Biphasic pulse without interphase gap

Biphasic pulse with interphase gap

Arm Description

Outcomes

Primary Outcome Measures

Therapeutic threshold (mA)

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

Side effect threshold (mA)

Amplitude needed to elicit non-transient side effects, expressed in milliamperes (mA)

Secondary Outcome Measures

Full Information

NCT ID

NCT05177900

First Posted

December 2, 2021

Last Updated

April 5, 2022

Sponsor

Myles Mc Laughlin

1. Study Identification

Unique Protocol Identification Number

NCT05177900

Brief Title

Interphase Gap in Biphasic Stimulation in DBS for ET

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

January 27, 2022 (Actual)

Study Completion Date

January 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Myles Mc Laughlin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Tremor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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).

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Biphasic pulse without interphase gap

Arm Type

Active Comparator

Arm Title

Biphasic pulse with interphase gap

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Study Tool Computer

Intervention Description

Nonconventional pulses delivered with custom-ware designed by Boston Scientific

Primary Outcome Measure Information:

Title

Therapeutic threshold (mA)

Description

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

Time Frame

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

Title

Side effect threshold (mA)

Description

Amplitude needed to elicit non-transient side effects, expressed in milliamperes (mA)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

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Interphase Gap in Biphasic Stimulation in DBS for ET

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