Stress Disorders, Post-TraumaticEEGCOVNCT06368999
Neurophysiological and Neuropsychological Evalution in Healthcare Workers
A study testing EEG in people with Stress Disorders, Post-Traumatic, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The goal of this observational study is to compare in participant population the effect of stress condition on cerebral EEG activity Participants will do an 8 minutes EEG registration. Researchers will compare EEG activity of heathcare workers. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- EEG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 27 May 2020to 9 Jan 2021
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthcare workers
Who cannot join
- neurological disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: Neurophysiological and Neuropsychological Evalution in Healthcare Workers of Stress Condition
The goal of this observational study is to compare in participant population the effect of stress condition on cerebral EEG activity Participants will do an 8 minutes EEG registration. Researchers will compare EEG activity of heathcare workers.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- EEG
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDiagnostic test
registration of 8 minutes of EEG
| Study group | Role | What they receive |
|---|---|---|
| heatlhcare workers | Experimental | Not described Receives: Diagnostic Test: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG activity
The subjects were instrumented with 19 bridge silver and silver chloride electrodes fitted on a plastic prewired head cap and placed on the scalp according to the 10-20 system (namely: Fp1, Fp2, F3, F4, F7, F8, Fz, C3, C4, Cz, P3, P4, Pz, T3, T4, T5, T6, O1, and O2), with an electroconductive paste applied between the electrodes and the skin to guarantee optimal connection The signals were recorded with a 512 Hz sampling frequency and filtered by an offline first order zero-phase Butterworth band-pass filter, with cutoff frequencies set, respectively, at 1.6 and 70 Hz to remove frequencies outside the range of interest. After this pre-processing, the main EEG rhythms and dominant frequencies were extracted by spectral and connectivity analyses. Delta (1.6-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), gamma1 (30-50 Hz), and gamma2 (50-70 Hz) frequency bands were considered.
Measured: immediately after the outbreak of the pandemic (first session) and almost 6 months later (second session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start27 May 2020
- Primary completion21 Dec 2020
- Study completion9 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- study of brain EEG activity
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368999
- Sponsor's protocol ID
- EEGCOV
- Acronym
- EEGCOV
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 16 Apr 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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological and Neuropsychological Evalution in Healthcare Workers of Stress Condition
- ClinicalTrials.gov ID
- NCT06368999
- Acronym / sponsor ID
- EEGCOV / EEGCOV
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 9 Jan 2021 (actual)
- First posted
- 16 Apr 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 goal of this observational study is to compare in participant population the effect of stress condition on cerebral EEG activity Participants will do an 8 minutes EEG registration. Researchers will compare EEG activity of heathcare workers.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- study of brain EEG activity
| Arm | Type | Receives |
|---|---|---|
| heatlhcare workers | Experimental | Diagnostic Test: EEG |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthcare workers
Key exclusion criteria (1 listed)
- neurological disorders
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 |
|---|---|---|
| EEGregistration of 8 minutes of EEG | Diagnostic test | heatlhcare workers |
Primary outcome
EEG activity
Time frame: immediately after the outbreak of the pandemic (first session) and almost 6 months later (second session).
The subjects were instrumented with 19 bridge silver and silver chloride electrodes fitted on a plastic prewired head cap and placed on the scalp according to the 10-20 system (namely: Fp1, Fp2, F3, F4, F7, F8, Fz, C3, C4, Cz, P3, P4, Pz, T3, T4, T5, T6, O1, and O2), with an electroconductive paste applied between the electrodes and the skin to guarantee optimal connection The signals were recorded with a 512 Hz sampling frequency and filtered by an offline first order zero-phase Butterworth band-pass filter, with cutoff frequencies set, respectively, at 1.6 and 70 Hz to remove frequencies outside the range of interest. After this pre-processing, the main EEG rhythms and dominant frequencies were extracted by spectral and connectivity analyses. Delta (1.6-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), gamma1 (30-50 Hz), and gamma2 (50-70 Hz) frequency bands were considered.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 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 EEG in people with Stress Disorders, Post-Traumatic, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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: finished, as of the sponsor's last update on 16 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EEG activity (time frame: immediately after the outbreak of the pandemic (first session) and almost 6 months later (second session).). 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 16 Apr 2024.