Acquisition and Analysis Protocol Optimization of Neurophysiological Data Neurorehabilitation Settings
NCT ID: NCT06297057
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
15 participants
INTERVENTIONAL
2024-03-31
2026-03-31
Brief Summary
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The investigation involves assessing the effect of eye conditions on brain network identification and determining the most stable and repeatable measures of functional connectivity over time. This analysis is crucial for discerning whether observed changes in patients' functional connections are intrinsic to the methodology or indicative of genuine physiological alterations.
The study aims to optimize protocols for rehabilitation by evaluating changes in functional connectivity metrics during and between experimental sessions. Furthermore, it seeks to identify the conditions (eyes closed or open) that yield more reliable and repeatable functional measurements.
Following the optimization of advanced techniques, the study explores the feasibility of utilizing the MUSE EEG system in clinical settings. MUSE, known for its portability and user-friendliness, has demonstrated quality in experimental psychology and clinical research. The objective is to establish relevant functional correspondences between measurements obtained through research techniques (hdEEG and MEG) and those acquired with MUSE.
The primary goal is to establish a protocol highlighting subjects' responses to acoustic stimuli or a reproducible pattern of resting state activity. The secondary objectives include investigating temporal and spatial characteristics of neurophysiological signals in healthy subjects over time and defining prognostic biomarkers for monitoring patients undergoing rehabilitation. This comprehensive approach aims to enhance the understanding of resting state functional connectivity and its applications in clinical settings.
Therefore, to meet these goals, the present study will consist of multiple recordings of brain activity: by high-density electroencephalography (hdEEG), magnetoencephalography (MEG), and low-density EEG with a MUSE handheld device, during five experimental blocks on healthy subjects.
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Detailed Description
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The sessions will take place in three consecutive weeks, once a week, taking care that these recordings are made at the same time of day for each participant. Finally, a structural magnetic resonance imaging (MRI) recording will be obtained for each participant.
Each neurophysiological data acquisition session will consist of 5 blocks: 4 eyes-open and eyes-closed resting-state blocks, and one passive auditory stimulation block.
The four blocks in the resting condition will always be performed first, to avoid interference due to the passive acoustic task. The order of blocks 1 and 2, and consequently also blocks 3 and 4, representing the open-eye and closed-eye conditions will be counterbalanced between participants and between different sessions for the same participant.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Neurophysiological Recordings
Participants suitable for hdEEG, MEG, and MUSE recordings will first undergo a neuronavigation session, and then three identical neurophysiological data acquisition sessions, one for hdEEG, one for MEG, and one for MUSE.
The sessions will take place in three consecutive weeks, once a week, taking care that they are made at the same time of day for each participant. Finally, a structural magnetic resonance imaging (MRI) recording will be obtained for each participant.
Each neurophysiological data acquisition session will consist of 5 blocks: 4 eyes-open and eyes-closed resting-state blocks, and one passive auditory stimulation block.
The four blocks in the resting condition will be performed first, to avoid interference due to the passive acoustic task. The order of blocks 1 and 2, and consequently also blocks 3 and 4, representing the open-eye and closed-eye conditions will be counterbalanced between subjects and between different sessions for the same subject.
Neurophysiological Recordings
Eyes-open resting-state blocks: these blocks will last 5 minutes each. Subjects will be asked to relax and not think about anything specific, keeping their eyes open and staring at a white cross in the center of a light grey screen to limit their eye movements.
Eyes-closed resting-state blocks: these blocks will last 5 minutes each. Subjects will be asked to relax and not think about anything specific, keeping their eyes closed.
ASSR: this block will last approximately 6 minutes. Stimuli will consist of a train of sounds presented repeatedly at high frequency.
MMN: this block will last approximately 3 minutes. Stimuli will consist of a train of equal sounds presented alternating with a 'deviant' (rarer frequency) sound.
Interventions
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Neurophysiological Recordings
Eyes-open resting-state blocks: these blocks will last 5 minutes each. Subjects will be asked to relax and not think about anything specific, keeping their eyes open and staring at a white cross in the center of a light grey screen to limit their eye movements.
Eyes-closed resting-state blocks: these blocks will last 5 minutes each. Subjects will be asked to relax and not think about anything specific, keeping their eyes closed.
ASSR: this block will last approximately 6 minutes. Stimuli will consist of a train of sounds presented repeatedly at high frequency.
MMN: this block will last approximately 3 minutes. Stimuli will consist of a train of equal sounds presented alternating with a 'deviant' (rarer frequency) sound.
Eligibility Criteria
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Inclusion Criteria
* ability to sign an informed consent form
Exclusion Criteria
* has had severe neurological or psychiatric disorders
* has eyesight problems that prevent him/her from reading, which she cannot correct with contact lenses (she will not be able to wear glasses during registration)
* habitually abused drugs or abused alcoholic substances
* has abused substances such as alcohol or drugs in the last three days
* is a wearer of hearing aids
* has metal and/or skull clips or other metal in any part of the head except the mouth
* has non-removable tattoos
* has piercings, earrings or other metal accessories that cannot be removed.
* is or could be pregnant (pregnancy in the first trimester)
* is a carrier of sickle cell anaemia
* is a cardiac pacemaker wearer or has an artificial heart valve
* has mechanical devices that he/she uses to administer medication
* has a surgical clip (vascular clips and metallic arterial prostheses made of ferromagnetic material)
* has a cochlear implant, a neurostimulator or a programmable hydrocephalic electrical conductor (shunt)
* has had brain surgery
* has implants or metal fragments in the body
18 Years
45 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
University of Padova
OTHER
IRCCS San Camillo, Venezia, Italy
OTHER
Responsible Party
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Locations
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San Camillo IRCCS s.r.l.
Venice-Lido, Venice, Italy
Countries
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Other Identifiers
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2021.07
Identifier Type: -
Identifier Source: org_study_id
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