NCT06298097

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2020

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2025

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

4.6 years

First QC Date

February 13, 2024

Last Update Submit

March 1, 2024

Conditions

Stroke

Keywords

high-density electroencephalographybrain connectivity

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (35)

  • Muscle strength measurement (work package 3)

    Immediately after the recruiting

  • Muscle strength measurement (work package 3)

    1 month after the recruiting

  • Muscle strength measurement (work package 3)

    2 months after the recruiting

  • Muscle strength measurement (work package 3)

    4 months after the recruiting

  • Muscle strength measurement (work package 3)

    6 months after the recruiting

  • +30 more secondary outcomes

Study Arms (2)

stroke patients

OTHER

Resting-state networks obtained through electroencephalography will be analyzed in a group of stroke patients.

Device: Connectivity measures

healthy participants

OTHER

Resting-state networks obtained through electroencephalography will be analyzed in a group of healthy participants.

Device: Connectivity measures

Interventions

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.

healthy participantsstroke patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • no comorbidities with psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Camillo Hospital

Venice, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Dante Mantini

CONTACT

+39 0412207594dante.mantini@hsancamillo.it

Giorgio Arcara

CONTACT

giorgio.arcara@hsancamillo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2024

First Posted

March 7, 2024

Study Start

June 11, 2020

Primary Completion

February 2, 2025

Study Completion

February 2, 2025

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)