Patients With Frontal and Parietal Lobe DysfunctionNCT05767489
Study of Brain Anatomo-functional Substrates Related to the Use of Human Tool by Means of Simultaneous Acquisition of Magnetic Resonance Imaging and Electroencephalogram
An observational study of Patients With Frontal and Parietal Lobe Dysfunction, run by IRCCS SYNLAB SDN at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients With Frontal and Parietal Lobe Dysfunction
- What is being tested?
- electroencephalogram (EEG) and magnetic resonance (MR)
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jan 2021to 17 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with brain dysfunction, particularly affecting the lobe frontal, temporal and parietal
Who may be able to join
- 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
Who cannot join
- pregnant or presumed pregnant subjects and subjects with claustrophobia or with contraindications to the examination.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Synlab SDN
Naples, 80143
Laura Pierri, MSC, 0812408470, direzionescientifica.irccssdn@synlab.it
About this study
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
- Being tested
- electroencephalogram (EEG) and magnetic resonance (MR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start18 Jan 2021
- Primary completion31 Jan 2024
- Study completion17 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Frontal and Parietal Lobe DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS SYNLAB SDN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767489
- Sponsor's protocol ID
- 8/20
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Brain Anatomo-functional Substrates Related to the Use of Human Tool by Means of Simultaneous Acquisition of Magnetic Resonance Imaging and Electroencephalogram
- ClinicalTrials.gov ID
- NCT05767489
- Acronym / sponsor ID
- 8/20
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS SYNLAB SDNUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 17 Jan 2025 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with brain dysfunction, particularly affecting the lobe frontal, temporal and parietal
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- pregnant or presumed pregnant subjects and subjects with claustrophobia or with contraindications to the examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroencephalogram (EEG) and magnetic resonance (MR)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 | Combination product | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Frontal and Parietal Lobe Dysfunction, run by IRCCS SYNLAB SDN at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combination of EEG and functional MR (fMRI) (time frame: 1-36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.