Interphase Gap in Biphasic Stimulation in DBS for ET

April 5, 2022 updated by: Myles Mc Laughlin

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myles Mc Laughlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

January 27, 2022

Study Completion (Actual)

January 27, 2022

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s61020_IPG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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