Study of Brain Anatomo-functional Substrates Related to the Use of Human Tool by Means of Simultaneous Acquisition of Magnetic Resonance Imaging and Electroencephalogram

NCT05767489 | Unknown

• 1 other identifier: 8/20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study, conducted on subjects with neurological disorders primarily involving the frontal and parietal lobes of the brain. Throughout the indicated period, the study will aim to enroll 100 subjects divided into 30 units per year. Specifically, the study will be carried out on patients with fronto-parietal dysfunction for whom a prescribed a clinical investigation of electroencephalogram and MRI

Conditions

Patients With Frontal and Parietal Lobe Dysfunction

Outcome Measures

Primary Outcomes (1)

• Combination of EEG and functional MR (fMRI)

  Interception of differences during simultaneous acquisition related to the variation of action readiness (action readiness) suggested by the visual-perceptual context

  1-36 months

Interventions

electroencephalogram (EEG) and magnetic resonance (MR) COMBINATION_PRODUCT

High-resolution 3D T1 and T2 sequences, acquired in the sagittal plane and MR reconstructed in the remaining orthogonal planes, for morphological assessment of different cortical and subcortical. EEG tracing involving recording channels such as eye tracking (eye-tracking: electrooculogram, pupillometry, saccades, fixation times on areas predefined areas), performance measures (response times), electrocardiogram and electromyogram proper to clinical acquisition

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with brain dysfunction, particularly affecting the lobe frontal, temporal and parietal

You may qualify if:

• subjects of either sex with fronto-parietal dysfunction, who are able to able to provide voluntary consent, who have been asked for clinical purposes for an EEG and an MRI

You may not qualify if:

• pregnant or presumed pregnant subjects and subjects with claustrophobia or with contraindications to the examination.

Sponsors & Collaborators

• IRCCS SYNLAB SDN: lead

Study Sites (1)

IRCCS Synlab SDN

Naples, 80143, Italy

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: January 18, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 17, 2025
• Last Updated: March 25, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)