HealthyMEEGOPTINCT06297057
Acquisition and Analysis Protocol Optimization of Neurophysiological Data Neurorehabilitation Settings
A study testing Neurophysiological Recordings in people with Healthy, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Neurophysiological Recordings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2024to Mar 2026
- Phase
- Interventional
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 65
- ability to sign an informed consent form
Who cannot join
- has suffered/is suffering from epileptic seizures.
- has had severe neurological or psychiatric disorders
- has eyesight problems that prevent him/her from reading, which she cannot correct with contact lenses (she will not be able to wear glasses during registration)
- habitually abused drugs or abused alcoholic substances
- has abused substances such as alcohol or drugs in the last three days
- is a wearer of hearing aids
Show all 17Show fewer
- has metal and/or skull clips or other metal in any part of the head except the mouth
- has non-removable tattoos
- has piercings, earrings or other metal accessories that cannot be removed.
- is or could be pregnant (pregnancy in the first trimester)
- is a carrier of sickle cell anaemia
- is a cardiac pacemaker wearer or has an artificial heart valve
- has mechanical devices that he/she uses to administer medication
- has a surgical clip (vascular clips and metallic arterial prostheses made of ferromagnetic material)
- has a cochlear implant, a neurostimulator or a programmable hydrocephalic electrical conductor (shunt)
- has had brain surgery
- has implants or metal fragments in the body
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acquisition and Analysis Protocol Optimization of Neurophysiological Data in Neurorehabilitation Setting: Pilot Study on Healthy Subjects
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.
Read more
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Neurophysiological Recordings
- Keywords
- connectivity, MEEG, resting state, Mismatch Negativity (MMN), Auditory Steady State Response (ASSR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurophysiological RecordingsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurophysiological Recordings | Experimental | Participants suitable for hdEEG, MEG, and MUSE recordings 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 they 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 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 subjects and between different sessions for the same subject. Receives: Other: Neurophysiological Recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurophysiological data acquisition protocol - resting state
Resting state measure from MEEG data: Power spectrum density values (delta, theta, alpha, beta, gamma frequency)
Measured: T1: first week, T2: second week, T3: third week
Neurophysiological data acquisition protocol - resting state
Resting state measure from MEEG data: Connectivity values at source level (delta, theta, alpha, beta, gamma frequency)
Measured: T1: first week, T2: second week, T3: third week
Neurophysiological data acquisition protocol - auditory stimulation
ASSR response (as measured from auditory stimulation)
Measured: T1: first week, T2: second week, T3: third week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, University of Padova
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297057
- Sponsor's protocol ID
- 2021.07
- Acronym
- MEEGOPTI
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquisition and Analysis Protocol Optimization of Neurophysiological Data in Neurorehabilitation Setting: Pilot Study on Healthy Subjects
- ClinicalTrials.gov ID
- NCT06297057
- Acronym / sponsor ID
- MEEGOPTI / 2021.07
- Conditions
- Healthy
- Keywords
- connectivity, MEEG, resting state, Mismatch Negativity (MMN), Auditory Steady State Response (ASSR)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Collaborators
- University Ghent, University of Padova
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 6 Mar 2024 (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.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurophysiological Recordings | Experimental | Other: Neurophysiological RecordingsParticipants suitable for hdEEG, MEG, and MUSE recordings 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 they 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 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 subjects and between different sessions for the same subject. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age between 18 and 65
- ability to sign an informed consent form
Key exclusion criteria (17 listed)
- has suffered/is suffering from epileptic seizures.
- has had severe neurological or psychiatric disorders
- has eyesight problems that prevent him/her from reading, which she cannot correct with contact lenses (she will not be able to wear glasses during registration)
- habitually abused drugs or abused alcoholic substances
- has abused substances such as alcohol or drugs in the last three days
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 |
|---|---|---|
| Neurophysiological RecordingsEyes-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. | Other | Neurophysiological Recordings |
Primary outcome
Neurophysiological data acquisition protocol - resting state
Time frame: T1: first week, T2: second week, T3: third week
Resting state measure from MEEG data: Power spectrum density values (delta, theta, alpha, beta, gamma frequency)
Neurophysiological data acquisition protocol - resting state
Time frame: T1: first week, T2: second week, T3: third week
Resting state measure from MEEG data: Connectivity values at source level (delta, theta, alpha, beta, gamma frequency)
Neurophysiological data acquisition protocol - auditory stimulation
Time frame: T1: first week, T2: second week, T3: third week
ASSR response (as measured from auditory stimulation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurophysiological Recordings in people with Healthy, run by IRCCS San Camillo, Venezia, Italy 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 2 inclusion and 17 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 6 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurophysiological data acquisition protocol - resting state (time frame: T1: first week, T2: second week, T3: third week). The study lists 3 primary outcomes in all. 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 6 Mar 2024.