Optimization of Parameters of Subthalamic Nucleus Stimulation

NCT03496532 | Withdrawn

• 1 other identifier: 2017-01832
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• Comparison of quantity of Beta oscillations after biphasic pulses vs standard monophasic pulses

  % 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

  % of changes in the energy of Beta oscillations

  10 minutes per patient

• Observe the evolution of Beta oscillations during deep anesthesia

  Energy of Beta oscillations

  2 minutes per patient

Study Arms (2)

Pulse generator change under sedation

EXPERIMENTAL

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; Device: standard stimulation; Device: Uniform distribution; Device: Poisson distribution

First pulse generator implantation under general an

EXPERIMENTAL

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

Interventions

biphasic stimulation DEVICE

Fixed 70Hz symmetrical biphasic pulses

Pulse generator change under sedation

standard stimulation DEVICE

Fixed 70Hz pseudo-monophasic pulses

Pulse generator change under sedation

Uniform distribution DEVICE

Uniform distribution 70Hz Biphasic pulses

Pulse generator change under sedation

Poisson distribution DEVICE

Poisson distribution 70Hz Biphasic pulses

Pulse generator change under sedation

Recordings of LFP oscillations 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.

First pulse generator implantation under general an

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Colette Boex: lead

Study Sites (1)

University of Geneva

Geneva, Switzerland

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Poisson Distribution

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Statistical Distributions; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Different stimulation paradigm tested sequentially in every patient of the group

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 12, 2018
• Study Start: October 10, 2018
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: August 13, 2021

Record last verified: 2021-08

Locations

CH (1)