Brain Connectivity Measured With High-density Electroencephalography

Stroke Clinical Trial

— NEUROCONN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298097
• Other study ID #: 2019.11
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2020
• Est. completion date: February 2, 2025

Study information

• Verified date: March 2024
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: Dante Mantini
• Phone: +39 0412207594
• Email: dante.mantini[@]hsancamillo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: February 2, 2025
• Est. primary completion date: February 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS San Camillo Hospital	Venice

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Spasticity measurement (work package 3)	Spasticity will be measured in the patients by using the Modified Ashworth Score	Immediately after the recruiting
Secondary	Spasticity measurement (work package 3)	Spasticity will be measured in the patients by using the Modified Ashworth Score	1 month after the recruiting
Secondary	Spasticity measurement (work package 3)	Spasticity will be measured in the patients by using the Modified Ashworth Score	2 months after the recruiting
Secondary	Spasticity measurement (work package 3)	Spasticity will be measured in the patients by using the Modified Ashworth Score	4 months after the recruiting
Secondary	Spasticity measurement (work package 3)	Spasticity will be measured in the patients by using the Modified Ashworth Score	6 months after the recruiting
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pain measurement (work package 3)	Pain level will be measured in the patients by the Visual Analog Scale for Pain	Immediately after the recruiting
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cognitive performance measurements (work package 3)	Cognitive functions will be measured in the patients by using the Oxford Cognitive Screen	Immediately after the recruiting
Secondary	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
Secondary	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
Secondary	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
Secondary	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