Electrophysiological Signature of Mild Cognitive Impairment and Its Relationship with Parkinson's Disease: a High-density EEG Investigation

NCT06640673 | Recruiting DMC

• 1 other identifier: 2023.06
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate neural correlate of Mild Cognitive Impairment (MCI) in Parkinson's disease (PD) and to identify a link between functional impairment (in both cognitive and motor domains) and electrophysiological cortical sing of MCI in PD. A sample of 42 subjects will be divide into three subgroup: healthy control, PD with MCI (PD-MCI) and PD without MCI (PD-ctrl). Those subjects will undergo a specific neuropsychological evaluation and, to measure the electro-cortical activity, high-density electroencephalography (hdEEG) will be record during both resting state and cognitive tasks. Furthermore, hdEEG data will be combine with structural magnetic resonance to obtain information about network connectivity.

Conditions

Parkinson Disease; Parkinson Disease, Mild Cognitive Impairment; Healthy

Keywords

MCI in PD; Mild Cognitive Impairment; Parkinson's disease; Hd-EEG

Outcome Measures

Primary Outcomes (4)

• Power Spectrum Density Analysis profile for hdEEG resting state data

  For all the groups, starting from the hdEEG data, brain oscillation will be studied by performing the Power Spectral Analysis (PSD). The PSD aims to investigate the spectral properties in the delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (\>30Hz) frequencies bands. PSD will be performed for each electrode, for each subject, and then averaged across subjects, obtaining a value of PSD for each electrode, separately for each group (PD-ctrl vs PD-MCI). Then the PSD value will be displayed over the scalp with a topological representation.

  at baseline

• Power Spectrum Density Analysis profile for hdEEG during cognitive task data

  For all the groups, starting from the hdEEG data, brain oscillation will be studied by performing the Power Spectral Analysis (PSD). The PSD aims to investigate the spectral properties in the delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (\>30 Hz) frequencies bands. PSD will be performed for each electrode, for each subject, and then averaged across subject obtaining value of PSD for each electrode, separately for each group (PD-ctrl vs PD-MCI). Then the PSD value will be displayed over the scalp with a topological representation.

  at baseline

• Functional connectivity - seed based analysis for hdEEG resting state data

  To study the temporal correlation of cortical signals generated in spatially distributed regions of interest (ROI), the collected hdEEG data will be analyzed using the seed-based functional connectivity analysis (FC-SBA). FC-SBA will measures the time course activation of specific resting state networks (RSNs). Specifically, the DMN (default mode network), SN (Salience Network), FPN1 and FNP2 (Fronto-parietal Network). This approach allows to obtain the functional connectivity matrices that will show the activation pattern of different RSNs and frequency bands (delta 1-4Hz; theta 4-8Hz; alpha 8-13 Hz, beta 13-30Hz; gamma \>30Hz).

  at baseline

• Functional connectivity - seed based analysis for hdEEG during cognitive task data

  To study the temporal correlation of cortical signals generated in spatially distributed regions of interest (ROI), the collected hdEEG data will be analyzed using the seed-based functional connectivity analysis (FC-SBA). FC-SBA will measures the time course activation of specific resting state networks (RSNs). Specifically, the DMN (default mode network), SN (Salience Network), FPN1 and FNP2 (Fronto-parietal Network). This approach allows to obtain the functional connectivity matrices that will show the activation pattern of different RSNs and frequency bands (delta 1-4Hz; theta 4-8Hz; alpha 8-13 Hz, beta 13-30Hz; gamma \>30Hz).

  at baseline

Secondary Outcomes (3)

• Performances at neuropsychological evaluation

  at baseline

• Fraility assessment

  at baseline

• Accuracy during cognitive task

  at baseline

Study Arms (3)

PD-MCI

Parkinson's disease with Mild Cognitive Impairment

Diagnostic Test: Hd-EEG

PD-nMCI

Parkinson's disease without Mild Cognitive Impairment

Diagnostic Test: Hd-EEG

Healthy control

Healthy participants matched for age and gender with the experimental groups

Diagnostic Test: Hd-EEG

Interventions

Hd-EEG DIAGNOSTIC_TEST

Subjects undergo a clinical and neuropsychological assesment, then a Hd-EEG both during resting state and execution of tasks, and structural Magnetic Resonance Imaging

Also known as: MRI

Healthy control; PD-MCI; PD-nMCI

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's patients will be recruited in the IRCCS San Camillo Hospital or through collaborators of the responsible researchers. Healty controls will be enrolled voluntarily.

You may qualify if:

• Upper score \>24 MMSE or \>15.5 Moca
• Having signed the informed consent

You may not qualify if:

• Subjects with severe dementia ( MMSE \< 24 )
• Lower score \<15.5 Moca
• Subjects on antipsychotic treatment for less than 3 months
• Subjects with uncontrolled comorbidities
• Subjects with metal prostheses or dentures and in general conditions for which MRI examinations are prevented.
• Subjects with an inability to walk independently.

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

IRCCS San Camillo S.R.L

Lido, Italy, Italy

RECRUITING

Related Publications (8)

• Nagano-Saito A, Habak C, Mejia-Constain B, Degroot C, Monetta L, Jubault T, Bedetti C, Lafontaine AL, Chouinard S, Soland V, Ptito A, Strafella AP, Monchi O. Effect of mild cognitive impairment on the patterns of neural activity in early Parkinson's disease. Neurobiol Aging. 2014 Jan;35(1):223-31. doi: 10.1016/j.neurobiolaging.2013.06.025. Epub 2013 Aug 7.

  PMID: 23932879 BACKGROUND

• Betrouni N, Devignes Q, Bayot M, Derambure P, Defebvre L, Leentjens AF, Delval A, Dujardin K. The frontostriatal subtype of mild cognitive impairment in Parkinson's disease, but not the posterior cortical one, is associated with specific EEG alterations. Cortex. 2022 Aug;153:166-177. doi: 10.1016/j.cortex.2022.04.015. Epub 2022 May 11.

  PMID: 35667287 BACKGROUND

• Monchi O, Petrides M, Doyon J, Postuma RB, Worsley K, Dagher A. Neural bases of set-shifting deficits in Parkinson's disease. J Neurosci. 2004 Jan 21;24(3):702-10. doi: 10.1523/JNEUROSCI.4860-03.2004.

  PMID: 14736856 BACKGROUND

• Samogin J, Marino M, Porcaro C, Wenderoth N, Dupont P, Swinnen SP, Mantini D. Frequency-dependent functional connectivity in resting state networks. Hum Brain Mapp. 2020 Dec 15;41(18):5187-5198. doi: 10.1002/hbm.25184. Epub 2020 Aug 25.

  PMID: 32840936 BACKGROUND

• Cai M, Dang G, Su X, Zhu L, Shi X, Che S, Lan X, Luo X, Guo Y. Identifying Mild Cognitive Impairment in Parkinson's Disease With Electroencephalogram Functional Connectivity. Front Aging Neurosci. 2021 Jul 1;13:701499. doi: 10.3389/fnagi.2021.701499. eCollection 2021.

  PMID: 34276350 BACKGROUND

• Cera N, Esposito R, Cieri F, Tartaro A. Altered Cingulate Cortex Functional Connectivity in Normal Aging and Mild Cognitive Impairment. Front Neurosci. 2019 Sep 13;13:857. doi: 10.3389/fnins.2019.00857. eCollection 2019.

  PMID: 31572106 BACKGROUND

• Gorges M, Muller HP, Lule D; LANDSCAPE Consortium; Pinkhardt EH, Ludolph AC, Kassubek J. To rise and to fall: functional connectivity in cognitively normal and cognitively impaired patients with Parkinson's disease. Neurobiol Aging. 2015 Apr;36(4):1727-1735. doi: 10.1016/j.neurobiolaging.2014.12.026. Epub 2014 Dec 31.

  PMID: 25623332 BACKGROUND

• Litvan I, Goldman JG, Troster AI, Schmand BA, Weintraub D, Petersen RC, Mollenhauer B, Adler CH, Marder K, Williams-Gray CH, Aarsland D, Kulisevsky J, Rodriguez-Oroz MC, Burn DJ, Barker RA, Emre M. Diagnostic criteria for mild cognitive impairment in Parkinson's disease: Movement Disorder Society Task Force guidelines. Mov Disord. 2012 Mar;27(3):349-56. doi: 10.1002/mds.24893. Epub 2012 Jan 24.

  PMID: 22275317 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• francesca burgio, phd

  San Camillo IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Burgio, PhD

CONTACT

+390412207536; francesca.burgio@hsancamillo.it

Giovanni Lazzaro, MSc

CONTACT

+3904122079598; giovanni.lazzaro@hsancamillo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: October 15, 2024
• Study Start: June 18, 2023
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

IT (1)