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Clinical Trials/NCT05284526
NCT05284526
Completed
Not Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country30 target enrollmentMay 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
30
Locations
1
Primary Endpoint
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).
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 9, 2022
End Date
April 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

  • 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

Outcomes

Primary Outcomes

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).

Time Frame: 18 months

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.

Study Sites (1)

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