Brain Connectivity Measured With High-density Electroencephalography (NEUROCONN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Connectivity measures

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dante Mantini; Phone Number: +39 0412207594; Email: dante.mantini@hsancamillo.it
• Study Contact Backup: Name: Giorgio Arcara; Email: giorgio.arcara@hsancamillo.it

Study Locations

• Italy
  • Venice, Italy
    • Recruiting
    • IRCCS San Camillo Hospital
    • Contact: Email: n.ricercaclinica@hsancamillo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: stroke patients; Resting-state networks obtained through electroencephalography will be analyzed in a group of stroke patients.	Device: Connectivity 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.
Other: healthy participants; Resting-state networks obtained through electroencephalography will be analyzed in a group of healthy participants.	Device: Connectivity 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-density electroencephalography measurements (work package 1, 2, and 3)	High-density electroencephalography measurements, specifically focusing on resting state networks, will be performed using either a 128-channel or a 256-channel system	Immediately after the recruiting
High-density electroencephalography measurements (work package 1, 2, and 3)	High-density electroencephalography measurements, specifically focusing on resting state networks, will be performed using either a 128-channel or a 256-channel system	1 month after the recruiting
High-density electroencephalography measurements (work package 1, 2, and 3)	High-density electroencephalography measurements, specifically focusing on resting state networks, will be performed using either a 128-channel or a 256-channel system	2 months after the recruiting
High-density electroencephalography measurements (work package 1, 2, and 3)	High-density electroencephalography measurements, specifically focusing on resting state networks, will be performed using either a 128-channel or a 256-channel system	4 months after the recruiting
High-density electroencephalography measurements (work package 1, 2, and 3)	High-density electroencephalography measurements, specifically focusing on resting state networks, will be performed using either a 128-channel or a 256-channel system	6 months after the recruiting
Magnetic Resonance Imaging measurement (work package 1, 2, and 3)	Magnetic Resonance Imaging will be conducted using a 3 Tesla scanner. Specifically, T1-weighted Magnetic Resonance Imaging measure will be collected	Immediately after the recruiting
Magnetic Resonance Imaging measurement (work package 1, 2, and 3)	Magnetic Resonance Imaging will be conducted using a 3 Tesla scanner. Specifically, T1-weighted Magnetic Resonance Imaging measure will be collected	1 month after the recruiting
Magnetic Resonance Imaging measurement (work package 1, 2, and 3)	Magnetic Resonance Imaging will be conducted using a 3 Tesla scanner. Specifically, T1-weighted Magnetic Resonance Imaging measure will be collected	2 months after the recruiting
Magnetic Resonance Imaging measurement (work package 1, 2, and 3)	Magnetic Resonance Imaging will be conducted using a 3 Tesla scanner. Specifically, T1-weighted Magnetic Resonance Imaging measure will be collected	4 months after the recruiting
Magnetic Resonance Imaging measurement (work package 1, 2, and 3)	Magnetic Resonance Imaging will be conducted using a 3 Tesla scanner. Specifically, T1-weighted Magnetic Resonance Imaging measure will be collected	6 months after the recruiting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength measurement (work package 3)	Muscle strength will be measured in the patients by using the Medical Research Council Score	Immediately after the recruiting
Muscle strength measurement (work package 3)	Muscle strength will be measured in the patients by using the Medical Research Council Score	1 month after the recruiting
Muscle strength measurement (work package 3)	Muscle strength will be measured in the patients by using the Medical Research Council Score	2 months after the recruiting
Muscle strength measurement (work package 3)	Muscle strength will be measured in the patients by using the Medical Research Council Score	4 months after the recruiting
Muscle strength measurement (work package 3)	Muscle strength will be measured in the patients by using the Medical Research Council Score	6 months after the recruiting
Sensorimotor impairment measurement (work package 3)	Sensorimotor impairment will be measured in the patients by using the Upper Extremity Fugl-Meyer index	Immediately after the recruiting
Sensorimotor impairment measurement (work package 3)	Sensorimotor impairment will be measured in the patients by using the Upper Extremity Fugl-Meyer index	1 month after the recruiting
Sensorimotor impairment measurement (work package 3)	Sensorimotor impairment will be measured in the patients by using the Upper Extremity Fugl-Meyer index	2 months after the recruiting
Sensorimotor impairment measurement (work package 3)	Sensorimotor impairment will be measured in the patients by using the Upper Extremity Fugl-Meyer index	4 months after the recruiting
Sensorimotor impairment measurement (work package 3)	Sensorimotor impairment will be measured in the patients by using the Upper Extremity Fugl-Meyer index	6 months after the recruiting
Spasticity measurement (work package 3)	Spasticity will be measured in the patients by using the Modified Ashworth Score	Immediately after the recruiting
Spasticity measurement (work package 3)	Spasticity will be measured in the patients by using the Modified Ashworth Score	1 month after the recruiting
Spasticity measurement (work package 3)	Spasticity will be measured in the patients by using the Modified Ashworth Score	2 months after the recruiting
Spasticity measurement (work package 3)	Spasticity will be measured in the patients by using the Modified Ashworth Score	4 months after the recruiting
Spasticity measurement (work package 3)	Spasticity will be measured in the patients by using the Modified Ashworth Score	6 months after the recruiting
Funtional skills measurement (work package 3).	Functional 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.	Immediately after the recruiting
Funtional skills measurement (work package 3).	Functional 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.	1 month after the recruiting
Funtional skills measurement (work package 3).	Functional 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.	2 months after the recruiting
Funtional skills measurement (work package 3).	Functional 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.	4 months after the recruiting
Funtional skills measurement (work package 3).	Functional 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.	6 months after the recruiting
Activities of daily living measurement (work package 3)	Activities of daily living will be measured in the patients by the Barthel Index	Immediately after the recruiting
Activities of daily living measurement (work package 3)	Activities of daily living will be measured in the patients by the Barthel Index	1 month after the recruiting
Activities of daily living measurement (work package 3)	Activities of daily living will be measured in the patients by the Barthel Index	2 months after the recruiting
Activities of daily living measurement (work package 3)	Activities of daily living will be measured in the patients by the Barthel Index	4 months after the recruiting
Activities of daily living measurement (work package 3)	Activities of daily living will be measured in the patients by the Barthel Index	6 months after the recruiting
Pain measurement (work package 3)	Pain level will be measured in the patients by the Visual Analog Scale for Pain	Immediately after the recruiting
Pain measurement (work package 3)	Pain level will be measured in the patients by the Visual Analog Scale for Pain	1 month after the recruiting
Pain measurement (work package 3)	Pain level will be measured in the patients by the Visual Analog Scale for Pain	2 months after the recruiting
Pain measurement (work package 3)	Pain level will be measured in the patients by the Visual Analog Scale for Pain	4 months after the recruiting
Pain measurement (work package 3)	Pain level will be measured in the patients by the Visual Analog Scale for Pain	6 months after the recruiting
Cognitive performance measurements (work package 3)	Cognitive functions will be measured in the patients by using the Oxford Cognitive Screen	Immediately after the recruiting
Cognitive performance measurements (work package 3)	Cognitive functions will be measured in the patients by using the Oxford Cognitive Screen	1 month after the recruiting
Cognitive performance measurements (work package 3)	Cognitive functions will be measured in the patients by using the Oxford Cognitive Screen	2 months after the recruiting
Cognitive performance measurements (work package 3)	Cognitive functions will be measured in the patients by using the Oxford Cognitive Screen	4 months after the recruiting
Cognitive performance measurements (work package 3)	Cognitive functions will be measured in the patients by using the Oxford Cognitive Screen	6 months after the recruiting

Collaborators and Investigators

• Sponsor: IRCCS San Camillo, Venezia, Italy

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Estimated): February 2, 2025
• Study Completion (Estimated): February 2, 2025

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: brain connectivity; high-density electroencephalography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2019.11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No