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

NCT05284526 | Completed

• 1 other identifier: APHP211327
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Study Arms (3)

parkinsonian patients with and without dopaminergic drug treatment

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

control subjects

ACTIVE COMPARATOR

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

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

Interventions

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

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

control subjects; parkinsonian patients with and without High-frequency stimulation of the subthalamic nucleus; parkinsonian patients with and without dopaminergic drug treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

DEGOS

Bobigny, 93009, France

Location

Related Publications (3)

• 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.

  PMID: 28752857 BACKGROUND

• 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.

  PMID: 24416360 BACKGROUND

• 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.

  PMID: 7815888 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 17, 2022
• Study Start: May 9, 2022
• Primary Completion: May 9, 2022
• Study Completion: April 21, 2023
• Last Updated: August 23, 2023

Record last verified: 2022-05

Locations

FR (1)