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EEG Recordings and Analysis in Parkinson's Patients: Towards Adaptive Deep Brain Stimulation by Machine Learning (ElectroPARK)

Primary Purpose

Parkinson Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

electroencephalogram (EEG) of control and parkinsonian subjects during the preparation and execution of movements

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring EEG, Montreal Cognitive Assessment, MDS-UPDRS III, MDS-UPDRS IV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients :

Patient over 18 years of age
Patient meeting the clinical diagnostic criteria for Parkinson's disease (Postuma et al, Mov Dis, 2015)
Signed consent to participate in the study
Absence of cognitive impairment (MoCA>24)
Affiliation to a French social security scheme

Healthy volunteer :

Healthy volunteer over 18 years of age
Signed consent to participate in the study
Absence of cognitive disorders (MoCA>24)
Affiliation to a French social security system

Exclusion Criteria:

Patients :

Patient refusal to participate
Pregnancy or breastfeeding in progress
Participation in another therapeutic interventional study
Patient under guardianship or curatorship
Person subject to a legal protection measure

Healthy volunteers :

Refusal of the healthy volunteer to participate
Pregnancy or breastfeeding in progress
Participation in another therapeutic interventional study.
Patient under guardianship or curatorship
Person subject to a legal protection measure

Sites / Locations

DEGOS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

parkinsonian patients with and without dopaminergic drug treatment

parkinsonian patients with and without High-frequency stimulation of the subthalamic nucleus

control subjects

Arm Description

Electroencephalogram (EEG) of 10 parkinsonian subjects with and without dopaminergic drug treatment during the preparation and execution of movements

Electroencephalogram (EEG) of 10 parkinsonian subjects with and without High-frequency stimulation (HFS) of the subthalamic nucleus (STN) during the preparation and execution of movements

Electroencephalogram (EEG) of control subjects during the preparation and execution of movements

Outcomes

Primary Outcome Measures

measure the encoding capacity of the cortical networks of parkinsonian patients, with or without anti-parkinsonian drug treatment, and with or without High-frequency stimulation (HFS) of the subthalamic nucleus (STN).

comparison of the success scores of motion recognition, obtained by the decoding algorithms, which will highlight differences in the encoding and transmission capabilities of cortical information between the different experimental groups.

Secondary Outcome Measures

Full Information

NCT ID

NCT05284526

First Posted

February 17, 2022

Last Updated

August 21, 2023

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

1. Study Identification

Unique Protocol Identification Number

NCT05284526

Brief Title

EEG Recordings and Analysis in Parkinson's Patients: Towards Adaptive Deep Brain Stimulation by Machine Learning

Acronym

ElectroPARK

Official Title

Prospective Study Evaluating the EEG Recordings and Analysis in Parkinson's Patients: Towards Adaptive Deep Brain Stimulation by Machine Learning

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

May 9, 2022 (Actual)

Primary Completion Date

May 9, 2022 (Actual)

Study Completion Date

April 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this protocol is to obtain on Parkinson's disease more accessible therapeutic targets than deep brain stimulation (HFS-STN), the neurosurgical treatment for this pathology. This study will pave the way for new forms of adaptive processing for the HFS-STN. It could become functionally coupled to a minimalist EEG centred on the motor cortex and to software for decoding, live or slightly delayed, classes of movements performed. On the one hand, this device could be used as a sensor of the quality of the information transmitted by the cortical network, thus allowing the selection of the optimal parameters of the HFS-STN on the basis of the movement decoding score. On the other hand, this device could lead to adapting the HFS-STN treatment over time by regularly calculating the recognition scores of the different movements performed and comparing them to the initial scores.

Detailed Description

One of the therapies for Parkinson's disease, a condition affecting nearly 150,000 patients in France, is the invasive neurosurgical implantation of high-frequency deep brain stimulation of the subthalamic nuclei (HFS-STN). Although HFS-STN is very effective, the underlying mechanisms are still relatively poorly understood, particularly at the cortical level, a region that could become an alternative therapeutic target because it is easier to access. This study aims to measure the changes induced by the antiparkinsonian drug treatment and the HFS-STN on the encoding and transmission of motor information at the level of the motor cortex, thanks to the recording of the electroencephalogram of patients. These recordings, made during the performance of certain movements, will be subjected to an analysis using "machine learning" methods that will make it possible to decode the identity of the movement performed more or less efficiently.

6. Conditions and Keywords

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

Parkinson Disease

Keywords

EEG, Montreal Cognitive Assessment, MDS-UPDRS III, MDS-UPDRS IV

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

parkinsonian patients with and without dopaminergic drug treatment

Arm Type

Experimental

Arm Description

Electroencephalogram (EEG) of 10 parkinsonian subjects with and without dopaminergic drug treatment during the preparation and execution of movements

Arm Title

parkinsonian patients with and without High-frequency stimulation of the subthalamic nucleus

Arm Type

Experimental

Arm Description

Electroencephalogram (EEG) of 10 parkinsonian subjects with and without High-frequency stimulation (HFS) of the subthalamic nucleus (STN) during the preparation and execution of movements

Arm Title

control subjects

Arm Type

Active Comparator

Arm Description

Electroencephalogram (EEG) of control subjects during the preparation and execution of movements

Intervention Type

Other

Intervention Name(s)

electroencephalogram (EEG) of control and parkinsonian subjects during the preparation and execution of movements

Intervention Description

electroencephalogram (EEG) of control and parkinsonian subjects during the preparation and execution of movements

Primary Outcome Measure Information:

Title

Description

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients : Patient over 18 years of age Patient meeting the clinical diagnostic criteria for Parkinson's disease (Postuma et al, Mov Dis, 2015) Signed consent to participate in the study Absence of cognitive impairment (MoCA>24) Affiliation to a French social security scheme Healthy volunteer : Healthy volunteer over 18 years of age Signed consent to participate in the study Absence of cognitive disorders (MoCA>24) Affiliation to a French social security system Exclusion Criteria: Patients : Patient refusal to participate Pregnancy or breastfeeding in progress Participation in another therapeutic interventional study Patient under guardianship or curatorship Person subject to a legal protection measure Healthy volunteers : Refusal of the healthy volunteer to participate Pregnancy or breastfeeding in progress Participation in another therapeutic interventional study. Patient under guardianship or curatorship Person subject to a legal protection measure

Facility Information:

Facility Name

DEGOS

City

Bobigny

ZIP/Postal Code

93009

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

28752857

Citation

Ashkan K, Rogers P, Bergman H, Ughratdar I. Insights into the mechanisms of deep brain stimulation. Nat Rev Neurol. 2017 Sep;13(9):548-554. doi: 10.1038/nrneurol.2017.105. Epub 2017 Jul 28.

Results Reference

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PubMed Identifier

24416360

Citation

Liao K, Xiao R, Gonzalez J, Ding L. Decoding individual finger movements from one hand using human EEG signals. PLoS One. 2014 Jan 8;9(1):e85192. doi: 10.1371/journal.pone.0085192. eCollection 2014.

Results Reference

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PubMed Identifier

7815888

Citation

Limousin P, Pollak P, Benazzouz A, Hoffmann D, Le Bas JF, Broussolle E, Perret JE, Benabid AL. Effect of parkinsonian signs and symptoms of bilateral subthalamic nucleus stimulation. Lancet. 1995 Jan 14;345(8942):91-5. doi: 10.1016/s0140-6736(95)90062-4.

Results Reference

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EEG Recordings and Analysis in Parkinson's Patients: Towards Adaptive Deep Brain Stimulation by Machine Learning

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