Viewing Study NCT06640673



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06640673
Status: RECRUITING
Last Update Posted: None
First Post: 2024-02-08

Brief Title: Electrophysiological Signature of Mild Cognitive Impairment and Its Relationship with Parkinsons Disease a High-density EEG Investigation
Sponsor: None
Organization: None

Study Overview

Official Title: Electrophysiological Signature of Mild Cognitive Impairment and Its Relationship with Parkinsons Disease a High-density EEG Investigation
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MMCI
Brief Summary: The study aims to investigate neural correlate of Mild Cognitive Impairment MCI in Parkinsons 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
Detailed Description: Parkinsons disease PD is a neurodegenerative disorder characterized by a degeneration of dopaminergic neurons at the level of the pars compacta of the substantia nigra which results in impaired control of the nigrostriatal pathway This degeneration is manifested by both motor and non-motor symptoms such bradykinesia tremor rigidity and cognitive disorders Particularly patients with PD might be affected by Mild Cognitive Impairment MCI dementia and related behavioral disorders including apathy and depressive syndromes However while motor disturbances are more evident it is difficult to evaluate the onset of cognitive symptoms especially in the prodromal phases of the disease Indeed it seems that the onset of cognitive deficits in PD occurs in a high prevalence in the earlier stages of the disease PD patients can often be associated with MCI a preclinical condition characterized by the presence of deficits in memory and executive functions as well as to a lesser extent in language- and visuospatial- related functions

Dual-syndrome hypothesis posit the existence of two subtypes of MCI one fronto-striatal characterised by executive and attentional deficits and a posterior cortical one characterised by deficits in memory visuo-spatial and language deficits Recent studies described alterations in brain rhythm measured with high-density EEG HDEEG in terms of frequency domain analysis at the level of fronto-striatal regions only in patients with the fronto-striatal subtype Moreover fMRI studies have shown that the presence of MCI in PD causes a reduction in activity at the level of the cognitive cortico-striatal loop which includes the caudate nucleus CN and prefrontal cortex PFC

Although the use of neurophysiological and neuroimaging techniques have substantially grown the available data highlight the lack of detailed descriptions of functional connectivity in relation whit the onset and extent of the cognitive deficit itself Therefore the aim of the present study is to characterise MCI in PD from a neurophysiological and clinical point of view First all patients undergo a neuropsychological assessment to identify PD patients with MCI PD-MCI and those without MCI PD-nMCI Then to investigate the functional connectivity of cortical areas underpinning cognitive decline HDEEG will be record during both resting state and cognitive tasks Furthermore for each participant will be collect MRI Magnetic resonance imaging to combine structural data with electrodes position over the scalp This would allow obtaining a realistic model of the head for source analysis

Identification of alterations in functional connectivity between specific cortical areas in MCI-PD patients and a possible direct relationship between these and clinical impairment could lead to improve therapeutic interventions and prevent cognitive disorders in PD patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None