Parkinson DiseaseElectroPARKNCT05284526
EEG Recordings and Analysis in Parkinson's Patients: Towards Adaptive Deep Brain Stimulation by Machine Learning
A study of Parkinson Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2022to 21 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Evaluating the EEG Recordings and Analysis in Parkinson's Patients: Towards Adaptive Deep Brain Stimulation by Machine Learning
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- electroencephalogram (EEG) of control and parkinsonian subjects during the preparation and execution of movements
- Keywords
- EEG, Montreal Cognitive Assessment, MDS-UPDRS III, MDS-UPDRS IV
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalogram (EEG) of control and parkinsonian subjects during the preparation and execution of movementsOther
electroencephalogram (EEG) of control and parkinsonian subjects during the preparation and execution of movements
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: electroencephalogram (EEG) of control and parkinsonian subjects during the preparation and execution of movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start9 May 2022
- Primary completion9 May 2022
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284526
- Sponsor's protocol ID
- APHP211327
- Acronym
- ElectroPARK
- Status last verified
- May 2022
- First submitted
- 17 Feb 2022
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28752857Liao 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.
PubMed 24416360Limousin 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.
PubMed 7815888
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the EEG Recordings and Analysis in Parkinson's Patients: Towards Adaptive Deep Brain Stimulation by Machine Learning
- ClinicalTrials.gov ID
- NCT05284526
- Acronym / sponsor ID
- ElectroPARK / APHP211327
- Conditions
- Parkinson Disease
- Keywords
- EEG, Montreal Cognitive Assessment, MDS-UPDRS III, MDS-UPDRS IV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 9 May 2022 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| parkinsonian patients with and without dopaminergic drug treatment | Experimental | Other: electroencephalogram (EEG) of control and parkinsonian subjects during the preparation and execution of movementsElectroencephalogram (EEG) of 10 parkinsonian subjects with and without dopaminergic drug treatment during the preparation and execution of movements |
| parkinsonian patients with and without High-frequency stimulation of the subthalamic nucleus | Experimental | Other: electroencephalogram (EEG) of control and parkinsonian subjects during the preparation and execution of movementsElectroencephalogram (EEG) of 10 parkinsonian subjects with and without High-frequency stimulation (HFS) of the subthalamic nucleus (STN) during the preparation and execution of movements |
| control subjects | Active comparator | Other: electroencephalogram (EEG) of control and parkinsonian subjects during the preparation and execution of movementsElectroencephalogram (EEG) of control subjects during the preparation and execution of movements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroencephalogram (EEG) of control and parkinsonian subjects during the preparation and execution of movementselectroencephalogram (EEG) of control and parkinsonian subjects during the preparation and execution of movements | Other | control subjects, parkinsonian patients with and without High-frequency stimulation of the subthalamic nucleus, parkinsonian patients with and without dopaminergic drug treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Background: PubMed 28752857Ashkan 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.
- Background: PubMed 24416360Liao 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.
- Background: PubMed 7815888Limousin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Parkinson Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05284526, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.