Clinical trial NCT06298097: Brain Connectivity Measured With High-density Electroencephalography
Official title: Brain Connectivity Measured With High-density Electroencephalography: a Novel Neurodiagnostic Tool for Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: high-density electroencephalography
brain connectivity
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: High-density electroencephalography measurements (work package 1, 2, and 3)
timeFrame: Immediately after the recruiting
measure: High-density electroencephalography measurements (work package 1, 2, and 3)
timeFrame: 1 month after the recruiting
measure: High-density electroencephalography measurements (work package 1, 2, and 3)
timeFrame: 2 months after the recruiting
measure: High-density electroencephalography measurements (work package 1, 2, and 3)
timeFrame: 4 months after the recruiting
measure: High-density electroencephalography measurements (work package 1, 2, and 3)
timeFrame: 6 months after the recruiting
measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3)
timeFrame: Immediately after the recruiting
measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3)
timeFrame: 1 month after the recruiting
measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3)
timeFrame: 2 months after the recruiting
measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3)
timeFrame: 4 months after the recruiting
measure: Magnetic Resonance Imaging measurement (work package 1, 2, and 3)
timeFrame: 6 months after the recruiting
Secondary outcomes:
measure: Muscle strength measurement (work package 3)
timeFrame: Immediately after the recruiting
measure: Muscle strength measurement (work package 3)
timeFrame: 1 month after the recruiting
measure: Muscle strength measurement (work package 3)
timeFrame: 2 months after the recruiting
measure: Muscle strength measurement (work package 3)
timeFrame: 4 months after the recruiting
measure: Muscle strength measurement (work package 3)
timeFrame: 6 months after the recruiting
measure: Sensorimotor impairment measurement (work package 3)
timeFrame: Immediately after the recruiting
measure: Sensorimotor impairment measurement (work package 3)
timeFrame: 1 month after the recruiting
measure: Sensorimotor impairment measurement (work package 3)
timeFrame: 2 months after the recruiting
measure: Sensorimotor impairment measurement (work package 3)
timeFrame: 4 months after the recruiting
measure: Sensorimotor impairment measurement (work package 3)
timeFrame: 6 months after the recruiting
measure: Spasticity measurement (work package 3)
timeFrame: Immediately after the recruiting
measure: Spasticity measurement (work package 3)
timeFrame: 1 month after the recruiting
measure: Spasticity measurement (work package 3)
timeFrame: 2 months after the recruiting
measure: Spasticity measurement (work package 3)
timeFrame: 4 months after the recruiting
measure: Spasticity measurement (work package 3)
timeFrame: 6 months after the recruiting
measure: Funtional skills measurement (work package 3).
timeFrame: Immediately after the recruiting
measure: Funtional skills measurement (work package 3).
timeFrame: 1 month after the recruiting
measure: Funtional skills measurement (work package 3).
timeFrame: 2 months after the recruiting
measure: Funtional skills measurement (work package 3).
timeFrame: 4 months after the recruiting
measure: Funtional skills measurement (work package 3).
timeFrame: 6 months after the recruiting
measure: Activities of daily living measurement (work package 3)
timeFrame: Immediately after the recruiting
measure: Activities of daily living measurement (work package 3)
timeFrame: 1 month after the recruiting
measure: Activities of daily living measurement (work package 3)
timeFrame: 2 months after the recruiting
measure: Activities of daily living measurement (work package 3)
timeFrame: 4 months after the recruiting
measure: Activities of daily living measurement (work package 3)
timeFrame: 6 months after the recruiting
measure: Pain measurement (work package 3)
timeFrame: Immediately after the recruiting
measure: Pain measurement (work package 3)
timeFrame: 1 month after the recruiting
measure: Pain measurement (work package 3)
timeFrame: 2 months after the recruiting
measure: Pain measurement (work package 3)
timeFrame: 4 months after the recruiting
measure: Pain measurement (work package 3)
timeFrame: 6 months after the recruiting
measure: Cognitive performance measurements (work package 3)
timeFrame: Immediately after the recruiting
measure: Cognitive performance measurements (work package 3)
timeFrame: 1 month after the recruiting
measure: Cognitive performance measurements (work package 3)
timeFrame: 2 months after the recruiting
measure: Cognitive performance measurements (work package 3)
timeFrame: 4 months after the recruiting
measure: Cognitive performance measurements (work package 3)
timeFrame: 6 months after the recruiting
Other outcomes:
Locations:
city: Venice
country: Italy
facility: IRCCS San Camillo Hospital
Study officials:
References: