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

March 22, 2024 updated by: IRCCS SYNLAB SDN
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combination of EEG and functional MR (fMRI)
Time Frame: 1-36 months
Interception of differences during simultaneous acquisition related to the variation of action readiness (action readiness) suggested by the visual-perceptual context
1-36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS SYNLAB SDN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2021

Primary Completion (Actual)

January 31, 2024

Study Completion (Estimated)

January 17, 2025

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 8/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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