Acquisition and Analysis Protocol Optimization of Neurophysiological Data Neurorehabilitation Settings

NCT06297057 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-03-06

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

OTHER

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.

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER
  • University of Padova

    collaborator OTHER
  • IRCCS San Camillo, Venezia, Italy

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2025-03-31
Completion
2026-03-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06297057 on ClinicalTrials.gov