Optimization of Parameters of Subthalamic Nucleus Stimulation

NCT ID: NCT03496532

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2021-05-03

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

biphasic stimulation

Intervention Type: DEVICE

Fixed 70Hz symmetrical biphasic pulses

standard stimulation

Intervention Type: DEVICE

Fixed 70Hz pseudo-monophasic pulses

Uniform distribution

Intervention Type: DEVICE

Uniform distribution 70Hz Biphasic pulses

Poisson distribution

Intervention Type: DEVICE

Poisson distribution 70Hz Biphasic pulses

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.

Group Type: EXPERIMENTAL

Recordings of LFP oscillations

Intervention Type: DEVICE

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.

Interventions

biphasic stimulation

Fixed 70Hz symmetrical biphasic pulses

Intervention Type: DEVICE

standard stimulation

Fixed 70Hz pseudo-monophasic pulses

Intervention Type: DEVICE

Uniform distribution

Uniform distribution 70Hz Biphasic pulses

Intervention Type: DEVICE

Poisson distribution

Poisson distribution 70Hz Biphasic pulses

Intervention Type: 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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colette Boex

OTHER

Sponsor Role: lead

Responsible Party

Colette Boex

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Geneva

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

2017-01832

Identifier Type: -

Identifier Source: org_study_id