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Optimization of Parameters of Subthalamic Nucleus Stimulation

Primary Purpose

Parkinson Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
biphasic stimulation
standard stimulation
Uniform distribution
Poisson distribution
Recordings of LFP oscillations
Sponsored by
Colette Boex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

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

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).

Sites / Locations

  • University of Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pulse generator change under sedation

First pulse generator implantation under general an

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Comparison of quantity of Beta oscillations after biphasic pulses vs standard monophasic pulses
% of changes in the energy of Beta oscillations
Comparison of quantity of Beta oscillations after pseudo random (Poisson distribution) vs uniform distribution of pulse time intervals
% of changes in the energy of Beta oscillations
Observe the evolution of Beta oscillations during deep anesthesia
Energy of Beta oscillations

Secondary Outcome Measures

Full Information

First Posted
March 14, 2018
Last Updated
August 6, 2021
Sponsor
Colette Boex
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1. Study Identification

Unique Protocol Identification Number
NCT03496532
Brief Title
Optimization of Parameters of Subthalamic Nucleus Stimulation
Official Title
Optimization of Parameters of Subthalamic Nucleus Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The study stoped becaus it did not even start No willing from our colleagues
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
May 3, 2021 (Actual)
Study Completion Date
May 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Colette Boex

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Different stimulation paradigm tested sequentially in every patient of the group
Masking
Participant
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulse generator change under sedation
Arm Type
Experimental
Arm Description
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).
Arm Title
First pulse generator implantation under general an
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
biphasic stimulation
Intervention Description
Fixed 70Hz symmetrical biphasic pulses
Intervention Type
Device
Intervention Name(s)
standard stimulation
Intervention Description
Fixed 70Hz pseudo-monophasic pulses
Intervention Type
Device
Intervention Name(s)
Uniform distribution
Intervention Description
Uniform distribution 70Hz Biphasic pulses
Intervention Type
Device
Intervention Name(s)
Poisson distribution
Intervention Description
Poisson distribution 70Hz Biphasic pulses
Intervention Type
Device
Intervention Name(s)
Recordings of LFP oscillations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of quantity of Beta oscillations after biphasic pulses vs standard monophasic pulses
Description
% of changes in the energy of Beta oscillations
Time Frame
10 minutes per patient
Title
Comparison of quantity of Beta oscillations after pseudo random (Poisson distribution) vs uniform distribution of pulse time intervals
Description
% of changes in the energy of Beta oscillations
Time Frame
10 minutes per patient
Title
Observe the evolution of Beta oscillations during deep anesthesia
Description
Energy of Beta oscillations
Time Frame
2 minutes per patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
University of Geneva
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

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Optimization of Parameters of Subthalamic Nucleus Stimulation

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