StrokeNEUROCONNNCT06298097
Brain Connectivity Measured With High-density Electroencephalography
A study testing Connectivity measures in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Connectivity measures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jun 2020to 2 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- right or left hemisphere damage
- unilateral stroke
- compliance with magnetic resonance imaging (e.g., no claustrophobia)
- compliance with magnetic resonance imaging (e.g., no claustrophobia)
- Exclusion Criteria (both patients and healthy participants):
- no comorbidities with psychiatric disorders
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Giorgio Arcara contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Camillo Hospital
Venice
n.ricercaclinica@hsancamillo.it
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- Connectivity measures
- Keywords
- high-density electroencephalography, brain connectivity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connectivity measuresDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| stroke patients | Other | Resting-state networks obtained through electroencephalography will be analyzed in a group of stroke patients. Receives: Device: Connectivity measures |
| healthy participants | Other | Resting-state networks obtained through electroencephalography will be analyzed in a group of healthy participants. Receives: Device: Connectivity measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after the recruiting
Secondary outcomes (35)
Muscle strength measurement (work package 3)
Muscle strength will be measured in the patients by using the Medical Research Council Score
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after the recruiting
Spasticity measurement (work package 3)
Spasticity will be measured in the patients by using the Modified Ashworth Score
Measured: Immediately after the recruiting
Spasticity measurement (work package 3)
Spasticity will be measured in the patients by using the Modified Ashworth Score
Measured: 1 month after the recruiting
Spasticity measurement (work package 3)
Spasticity will be measured in the patients by using the Modified Ashworth Score
Measured: 2 months after the recruiting
Spasticity measurement (work package 3)
Spasticity will be measured in the patients by using the Modified Ashworth Score
Measured: 4 months after the recruiting
Spasticity measurement (work package 3)
Spasticity will be measured in the patients by using the Modified Ashworth Score
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Immediately after the recruiting
Pain measurement (work package 3)
Pain level will be measured in the patients by the Visual Analog Scale for Pain
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Immediately after the recruiting
Cognitive performance measurements (work package 3)
Cognitive functions will be measured in the patients by using the Oxford Cognitive Screen
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after the recruiting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start11 Jun 2020
- Primary completion2 Feb 2025 (estimated)
- Study completion2 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298097
- Sponsor's protocol ID
- 2019.11
- Acronym
- NEUROCONN
- Status last verified
- Mar 2024
- First submitted
- 13 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Connectivity Measured With High-density Electroencephalography: a Novel Neurodiagnostic Tool for Stroke
- ClinicalTrials.gov ID
- NCT06298097
- Acronym / sponsor ID
- NEUROCONN / 2019.11
- Conditions
- Stroke
- Keywords
- high-density electroencephalography, brain connectivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 2 Feb 2025 (estimated)
- Study completion
- 2 Feb 2025 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stroke patients | Other | Device: Connectivity measuresResting-state networks obtained through electroencephalography will be analyzed in a group of stroke patients. |
| healthy participants | Other | Device: Connectivity measuresResting-state networks obtained through electroencephalography will be analyzed in a group of healthy participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- right or left hemisphere damage
- unilateral stroke
- compliance with magnetic resonance imaging (e.g., no claustrophobia)
- compliance with magnetic resonance imaging (e.g., no claustrophobia)
- no comorbidities with psychiatric disorders
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connectivity measuresElectroencephalography 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. | Device | healthy participants, stroke patients |
Primary outcome
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
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
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
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
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
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
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
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
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
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
35 secondary outcomes
Muscle strength measurement (work package 3)
Time frame: Immediately after the recruiting
Muscle strength measurement (work package 3)
Time frame: 1 month after the recruiting
Muscle strength measurement (work package 3)
Time frame: 2 months after the recruiting
Muscle strength measurement (work package 3)
Time frame: 4 months after the recruiting
Muscle strength measurement (work package 3)
Time frame: 6 months after the recruiting
Sensorimotor impairment measurement (work package 3)
Time frame: Immediately after the recruiting
Sensorimotor impairment measurement (work package 3)
Time frame: 1 month after the recruiting
Sensorimotor impairment measurement (work package 3)
Time frame: 2 months after the recruiting
Sensorimotor impairment measurement (work package 3)
Time frame: 4 months after the recruiting
Sensorimotor impairment measurement (work package 3)
Time frame: 6 months after the recruiting
Spasticity measurement (work package 3)
Time frame: Immediately after the recruiting
Spasticity measurement (work package 3)
Time frame: 1 month after the recruiting
Spasticity measurement (work package 3)
Time frame: 2 months after the recruiting
Spasticity measurement (work package 3)
Time frame: 4 months after the recruiting
Spasticity measurement (work package 3)
Time frame: 6 months after the recruiting
Funtional skills measurement (work package 3).
Time frame: Immediately after the recruiting
Funtional skills measurement (work package 3).
Time frame: 1 month after the recruiting
Funtional skills measurement (work package 3).
Time frame: 2 months after the recruiting
Funtional skills measurement (work package 3).
Time frame: 4 months after the recruiting
Funtional skills measurement (work package 3).
Time frame: 6 months after the recruiting
Activities of daily living measurement (work package 3)
Time frame: Immediately after the recruiting
Activities of daily living measurement (work package 3)
Time frame: 1 month after the recruiting
Activities of daily living measurement (work package 3)
Time frame: 2 months after the recruiting
Activities of daily living measurement (work package 3)
Time frame: 4 months after the recruiting
Activities of daily living measurement (work package 3)
Time frame: 6 months after the recruiting
Pain measurement (work package 3)
Time frame: Immediately after the recruiting
Pain measurement (work package 3)
Time frame: 1 month after the recruiting
Pain measurement (work package 3)
Time frame: 2 months after the recruiting
Pain measurement (work package 3)
Time frame: 4 months after the recruiting
Pain measurement (work package 3)
Time frame: 6 months after the recruiting
Cognitive performance measurements (work package 3)
Time frame: Immediately after the recruiting
Cognitive performance measurements (work package 3)
Time frame: 1 month after the recruiting
Cognitive performance measurements (work package 3)
Time frame: 2 months after the recruiting
Cognitive performance measurements (work package 3)
Time frame: 4 months after the recruiting
Cognitive performance measurements (work package 3)
Time frame: 6 months after the recruiting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgio Arcara contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connectivity measures in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dante Mantini (+39 0412207594, dante.mantini@hsancamillo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-density electroencephalography measurements (work package 1, 2, and 3) (time frame: Immediately after the recruiting). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.