Optimization of Parameters of Subthalamic Nucleus Stimulation

Not Applicable

Withdrawn

• Conditions: Parkinson Disease
• Interventions: Device: Recordings of LFP oscillations; Device: biphasic stimulation; Device: standard stimulation; Device: Uniform distribution; Device: Poisson distribution

• Registration Number: NCT03496532
• Lead Sponsor: Colette Boex

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.

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-12
• Study Start: 2018-10-10
• Primary Completion: 2021-05-03
• Study Completion: 2021-05-03
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Pulse generator change under sedation	Poisson distribution	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).
Pulse generator change under sedation	standard stimulation	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).
Pulse generator change under sedation	Uniform distribution	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).
First pulse generator implantation under general an	Recordings of LFP oscillations	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.
Pulse generator change under sedation	biphasic stimulation	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).

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Geneva; 🇨🇭 Geneva, Switzerland