Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-08
Brief Title:
Acquisition and Analysis Protocol Optimization of Neurophysiological Data Neurorehabilitation Settings
Sponsor:
IRCCS San Camillo Venezia Italy
Organization:
IRCCS San Camillo Venezia Italy
Study Overview
Official Title:
Acquisition and Analysis Protocol Optimization of Neurophysiological Data in Neurorehabilitation Setting Pilot Study on Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEEGOPTI
Brief Summary:
The study aims to optimize and validate protocols for acquiring neurophysiological data specifically resting state functional connectivity using advanced research techniques hdEEG and MEG and a user-friendly device MUSE Previous studies have extensively explored functional connectivity repeatability in resting conditions using functional MRI yet few have focused on hdEEG and MEG data Additionally the impact of subjects eye conditions open or closed during resting state recordings on network identification remains debated
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
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
Detailed Description:
Participants who will be identified as suitable for hdEEG MEG and MUSE recording 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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None