Recruiting · registry statusUsing scalp recordings to study thinking difficulties
Researchers use detailed recordings of electrical brain activity to investigate mild thinking difficulties and their relationship with Parkinson’s.
Learning by observing or collecting information · Study reference: NCT06640673
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
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- Start (reported actual date)
- 2023-06-18
- Main measurements finished (planned)
- 2024-12-01
- Study finished (planned)
- 2025-05
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
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Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Ages 50 years to 90 years · Also accepts healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Full study name & original research details
Official study title
Electrophysiological Signature of Mild Cognitive Impairment and Its Relationship with Parkinson's Disease: a High-density EEG Investigation
Original description
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.
Further description from the registry
Parkinson's 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.
Conditions reported: Parkinson Disease; Parkinson Disease, Mild Cognitive Impairment; Healthy
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Observational
- Interventions
- Hd-EEG
- Phases
- Not reported
- Sponsor
- IRCCS San Camillo, Venezia, Italy
- Start date reported by registry
- 2023-06-18 (actual)
Registry updated: 2024-10-15 · Status last verified by the registry submitter: 2024-10
Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Francesca Burgio, PhD · +390412207536 · francesca.burgio@hsancamillo.it
Giovanni Lazzaro, MSc · +3904122079598 · giovanni.lazzaro@hsancamillo.it
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
IRCCS San Camillo S.R.L
Lido, Italy, Italy
RecruitingFrancesca Burgio · +39 0412207536 · francesca.burgio@hsancamillo.it
Giovanni Lazzaro · 04122079598 · giovanni.lazzaro@hsancamillo.it
Facility not reported
Italy
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.