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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-90
SponsorIRCCS San Camillo, Venezia, Italy

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Upper score >24 MMSE or >15.5 Moca

If taking medications, taking stable doses for at least 4 weeks prior to the inclusion visit - of anticholinesterase drugs (donepezil, memantine, rivastigmine, ...) or antidepressants (SSRIs, tricyclics, SNARI, ...) or Levodopa.

Having signed the informed consent

Disqualifiers

Subjects with severe dementia ( MMSE < 24 )

Lower score <15.5 Moca

Subjects on antipsychotic treatment for less than 3 months

Subjects with uncontrolled comorbidities

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 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

Treatment groups

42 Participants
are divided into 3 treatment groups
Group A: PD-MCI1 intervention
Group B: PD-nMCI1 intervention
Group C: Healthy control1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at baseline
2

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.

Time frame
at baseline
3

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).

Time frame
at baseline
4

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).

Time frame
at baseline

Secondary outcomes

1

Performances at neuropsychological evaluation

Cognitive performances will be assessed before hdEEG by a neuropsychological battery encompassing the main cognitive domains. Specific neuropsychological tests will be administered according to the specific guideline for the cognitive evaluation in Parkinson's Disease, defined by the MDS Task Force. Raw scores at each test will be converted in z-scores based on each test normative data. Z-scores will be averaged to calculate composite scores for each cognitive domain. The composite scores will be the following: general cognitive functioning, attention, executive function, short-term memory, long-term memory, visuospatial abilities, language.

Time frame
at baseline
2

Fraility assessment

FRIED PHENOTYPE (PASE) analyzes 5 dimensions: presence of fatigue, grip strength, walking speed, unintentional weight loss, and level of activity. If at least 3 of these dimensions are deficient, then the patient is classified as frail; if 2 are deficient, the patient is pre-frail; if none are deficient, the patient is robust.

Time frame
at baseline
3

Accuracy during cognitive task

Accuracy during cognitive task will be extracted from the behavioral responses of each participant as the percentage of the correct responses. The accuracy at the task will be used as an additional parameter for analysis of the primary outcomes.

Time frame
at baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.