Optimization of Parameters of Subthalamic Nucleus Stimulation

August 6, 2021 updated by: Colette Boex

Deep brain stimulation of the subthalamic nucleus is an effective treatment for Parkinson's disease. The analysis of cerebral signals of the subthalamic nucleus by local field potentials, provides one of the main electrophysiological markers of the success of the stimulation. This marker can be used to evaluate new paradigms of stimulation. So far, little studied, the temporal characteristics of the stimulation are very important in the effectiveness of the stimulation of the subthalamic nucleus, in Parkinson's disease. The first objective (Study I) is to compare the effectiveness of the stimulation when it is applied with biphasic symmetrical pulses and when applied with the standard pulses applied so far.

The second objective (Study II) is to see if, by applying pseudo-random time intervals between each stimulation pulse, if it would be possible to improve the efficiency and to limit the side effects of the stimulation.

The third objective (Study III) is to evaluate the electrophysiological changes of the subthalamic nucleus caused by the general anesthesia, in the anticipation of the realization of the surgery of the stimulation of the subthalamic nucleus under general anesthesia.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Study I and II: Patients who participate undergo pulse generator change under sedation. Four sets of stimulation parameters will be compared. The efficacy of every set will be measured on induced changes in LFP recorded from the STN electrodes. LFP will be compared between before, during and right after each stimulation conditions. The stimulation order will be randomized. All other stimulation parameters will be the same (macrocontact with most beta-oscillations, 1 minute, 1.5mA) .

Study III: Patients who participate undergo their first pulse generator implantation, performed under general anesthesia because of wire tunnelisation. The depth of anesthesia will be documented, recording the BIS spectral analysis index. The difference in spectral amplitude density of LFP, in particular in beta band oscillations will be correlated with the depth of anesthesia as measured with the BIS index at the time of 2 minutes recordings.

Study Type

Interventional

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

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients suffering from Parkinson's disease, who must undergo surgery for the replacement of their neurostimulator (under sedation) or for the first positioning of it
  • capacity of discernment
  • informed signed consent

Exclusion Criteria:

  • Health considerations in regard to adding 13' in surgery room (e.g. pain or incomfort).

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulse generator change under sedation

The efficacy of every set will be measured on induced changes in LFP recorded from the STN electrodes.LFP will be compared between before, during and right after each stimulation conditions. The stimulation order will be randomized. All other stimulation parameters will be the same (macrocontact with most beta-oscillations, 1 minute, 1.5mA) .

Hence 4 sets of 1 minutes of STN stimulation will be performed, for:

Symmetrical biphasic pulses versus standard pseudo monophasic pulses (study I; 2 sets).

Pseudorandom uniform distribution stimulation paradigms versus pseudorandom Poisson distribution stimulation paradigms (study II: 2 sets).
Device: biphasic stimulation
Fixed 70Hz symmetrical biphasic pulses
Device: standard stimulation
Fixed 70Hz pseudo-monophasic pulses
Device: Uniform distribution
Uniform distribution 70Hz Biphasic pulses
Device: Poisson distribution
Poisson distribution 70Hz Biphasic pulses
Experimental: First pulse generator implantation under general an
The depth of anesthesia will be documented, recording the BIS spectral analysis index. The difference in spectral amplitude density of LFP, in particular in beta band oscillations will be correlated with the depth of anesthesia as measured with the BIS index.
Device: Recordings of LFP oscillations

Two minutes of recordings of LFP oscillations will be performed from the contacts of the implanted electrode.

Recordings of the depth of anaesthesia (BIS) all along the measurements performed under general anaesthesia.The correlation between the depth of anaesthesia and the cerebral oscillations recorded at the site of subthalamic nucleus will be studied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of quantity of Beta oscillations after biphasic pulses vs standard monophasic pulses
Time Frame: 10 minutes per patient
% of changes in the energy of Beta oscillations
10 minutes per patient
Comparison of quantity of Beta oscillations after pseudo random (Poisson distribution) vs uniform distribution of pulse time intervals
Time Frame: 10 minutes per patient
% of changes in the energy of Beta oscillations
10 minutes per patient
Observe the evolution of Beta oscillations during deep anesthesia
Time Frame: 2 minutes per patient
Energy of Beta oscillations
2 minutes per patient

Collaborators and Investigators

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

Sponsor

Colette Boex

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)

October 10, 2018

Primary Completion (Actual)

May 3, 2021

Study Completion (Actual)

May 3, 2021

Study Registration Dates

First Submitted

March 14, 2018

First Submitted That Met QC Criteria

April 5, 2018

First Posted (Actual)

April 12, 2018

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01832

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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