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Brain Connectivity Measured With High-density Electroencephalography

Brain Connectivity Measured With High-density Electroencephalography: a Novel Neurodiagnostic Tool for Stroke

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06298097
Acronym
NEUROCONN
Enrollment
170
Registered
2024-03-07
Start date
2020-06-11
Completion date
2025-02-02
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

high-density electroencephalography, brain connectivity

Brief summary

Emerging scientific results show that disrupted functional connectivity in stroke can explain behavioral impairments and predict their recovery over time. However, no technique is yet available for widespread use in clinics to examine how neural synchronization in brain networks is altered in stroke patients. This is crucial to determine favorable prognostic factors and to define individualized rehabilitation protocols. Importantly, the investigators have successfully used high-density electroencephalography (hdEEG) in healthy individuals to measure neural synchronization in brain networks. In this project, the investigators will develop methods and tools based on hdEEG for assessing functional connectivity in stroke patients. These methods and tools will be employed to examine how neural changes occurring after brain lesions explain behavioral impairments. The project will open the way for the use of hdEEG at the patient's bedside, as a neurodiagnostic tool for stroke as well as other brain disorders.

Interventions

DEVICEConnectivity measures

Electroencephalography connectivity measures will be collected and compared in both stroke patients and healthy participants. Connectivity measures will be extracted using these devices: high-density electroencephalography (using either a 128-channel or a 256-channel system) and magnetic resonance imaging.

Sponsors

IRCCS San Camillo, Venezia, Italy
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

In this study 125 stroke patients and 45 healthy participants will be recruited at the Institute for Research and Healthcare with a Scientific Character (IRCCS) San Camillo hospital. Inclusion Criteria (patients): * right or left hemisphere damage * unilateral stroke * compliance with magnetic resonance imaging (e.g., no claustrophobia) Inclusion Criteria (healthy participants): • compliance with magnetic resonance imaging (e.g., no claustrophobia)

Exclusion criteria

(both patients and healthy participants): • no comorbidities with psychiatric disorders

Design outcomes

Primary

MeasureTime frameDescription
High-density electroencephalography measurements (work package 1, 2, and 3)Immediately after the recruitingHigh-density electroencephalography measurements, specifically focusing on resting state networks, will be performed using either a 128-channel or a 256-channel system
Magnetic Resonance Imaging measurement (work package 1, 2, and 3)Immediately after the recruitingMagnetic Resonance Imaging will be conducted using a 3 Tesla scanner. Specifically, T1-weighted Magnetic Resonance Imaging measure will be collected

Secondary

MeasureTime frameDescription
Spasticity measurement (work package 3)Immediately after the recruitingSpasticity will be measured in the patients by using the Modified Ashworth Score
Funtional skills measurement (work package 3).Immediately after the recruitingFunctional skills will be measured in the patients by using the Functional Independence Measure index. Six domains of function are evaluated: self-care, sphincter control, transfers, locomotion, communication, and social cognition. Self-care activities include dressing, eating, grooming, and bathing.
Muscle strength measurement (work package 3)Immediately after the recruitingMuscle strength will be measured in the patients by using the Medical Research Council Score
Pain measurement (work package 3)Immediately after the recruitingPain level will be measured in the patients by the Visual Analog Scale for Pain
Cognitive performance measurements (work package 3)Immediately after the recruitingCognitive functions will be measured in the patients by using the Oxford Cognitive Screen
Activities of daily living measurement (work package 3)Immediately after the recruitingActivities of daily living will be measured in the patients by the Barthel Index
Sensorimotor impairment measurement (work package 3)Immediately after the recruitingSensorimotor impairment will be measured in the patients by using the Upper Extremity Fugl-Meyer index

Countries

Italy

Contacts

Primary ContactDante Mantini
dante.mantini@hsancamillo.it+39 0412207594
Backup ContactGiorgio Arcara
giorgio.arcara@hsancamillo.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026