Clinical trial NCT05284526: EEG Recordings and Analysis in Parkinson's Patients: Towards Adaptive Deep Brain Stimulation by Machine Learning
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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: EEG
Montreal Cognitive Assessment
MDS-UPDRS III
MDS-UPDRS IV
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

Patients :

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

Healthy volunteer :

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

Exclusion Criteria:

Patients :

1. Patient refusal to participate
2. Pregnancy or breastfeeding in progress
3. Participation in another therapeutic interventional study
4. Patient under guardianship or curatorship
5. Person subject to a legal protection measure

Healthy volunteers :

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

Primary outcomes:
measure: 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).
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bobigny
country: France
facility: DEGOS
Study officials:
References:
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.
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.
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.