Brain Connectivity Measured With High-density Electroencephalography (NEUROCONN)

March 1, 2024 updated by: IRCCS San Camillo, Venezia, Italy

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
High-density electroencephalography measurements (work package 1, 2, and 3)
Time Frame: Immediately after the recruiting
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)
Time Frame: 1 month after the recruiting
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)
Time Frame: 2 months after the recruiting
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)
Time Frame: 4 months after the recruiting
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)
Time Frame: 6 months after the recruiting
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)
Time Frame: Immediately after the recruiting
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)
Time Frame: 1 month after the recruiting
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)
Time Frame: 2 months after the recruiting
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)
Time Frame: 4 months after the recruiting
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)
Time Frame: 6 months after the recruiting
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle strength measurement (work package 3)
Time Frame: Immediately after the recruiting
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)
Time Frame: 1 month after the recruiting
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)
Time Frame: 2 months after the recruiting
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)
Time Frame: 4 months after the recruiting
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)
Time Frame: 6 months after the recruiting
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)
Time Frame: Immediately after the recruiting
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)
Time Frame: 1 month after the recruiting
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)
Time Frame: 2 months after the recruiting
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)
Time Frame: 4 months after the recruiting
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)
Time Frame: 6 months after the recruiting
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)
Time Frame: Immediately after the recruiting
Spasticity will be measured in the patients by using the Modified Ashworth Score
Immediately after the recruiting
Spasticity measurement (work package 3)
Time Frame: 1 month after the recruiting
Spasticity will be measured in the patients by using the Modified Ashworth Score
1 month after the recruiting
Spasticity measurement (work package 3)
Time Frame: 2 months after the recruiting
Spasticity will be measured in the patients by using the Modified Ashworth Score
2 months after the recruiting
Spasticity measurement (work package 3)
Time Frame: 4 months after the recruiting
Spasticity will be measured in the patients by using the Modified Ashworth Score
4 months after the recruiting
Spasticity measurement (work package 3)
Time Frame: 6 months after the recruiting
Spasticity will be measured in the patients by using the Modified Ashworth Score
6 months after the recruiting
Funtional skills measurement (work package 3).
Time Frame: Immediately after the recruiting
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).
Time Frame: 1 month after the recruiting
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).
Time Frame: 2 months after the recruiting
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).
Time Frame: 4 months after the recruiting
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).
Time Frame: 6 months after the recruiting
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)
Time Frame: Immediately after the recruiting
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)
Time Frame: 1 month after the recruiting
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)
Time Frame: 2 months after the recruiting
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)
Time Frame: 4 months after the recruiting
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)
Time Frame: 6 months after the recruiting
Activities of daily living will be measured in the patients by the Barthel Index
6 months after the recruiting
Pain measurement (work package 3)
Time Frame: Immediately after the recruiting
Pain level will be measured in the patients by the Visual Analog Scale for Pain
Immediately after the recruiting
Pain measurement (work package 3)
Time Frame: 1 month after the recruiting
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)
Time Frame: 2 months after the recruiting
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)
Time Frame: 4 months after the recruiting
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)
Time Frame: 6 months after the recruiting
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)
Time Frame: Immediately after the recruiting
Cognitive functions will be measured in the patients by using the Oxford Cognitive Screen
Immediately after the recruiting
Cognitive performance measurements (work package 3)
Time Frame: 1 month after the recruiting
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)
Time Frame: 2 months after the recruiting
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)
Time Frame: 4 months after the recruiting
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)
Time Frame: 6 months after the recruiting
Cognitive functions will be measured in the patients by using the Oxford Cognitive Screen
6 months after the recruiting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS San Camillo, Venezia, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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