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Can a simple test spot sudden-onset neuropsychiatric syndrome in kids?

NCT ID NCT07718958

Knowledge-focused Sponsor: University of Cagliari Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) causes sudden, severe behavioral and cognitive changes in children, but doctors currently rely only on symptoms for diagnosis. This study aims to identify biological markers—such as genetic, metabolic, and sleep-related signals—that could confirm the condition and track how well treatments work. Researchers will evaluate 80 children with PANS using psychological tests, sleep monitoring, and lab analyses, comparing them to healthy controls. Finding objective biomarkers may lead to earlier diagnosis and more personalized care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to objective diagnostic tests and better-targeted treatments for PANS, reducing reliance on symptom-based diagnosis alone.
What could go wrong
This is an early-stage biomarker discovery study, not a treatment trial. The identified markers may not prove reliable in larger, diverse populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of children and adolescents with a diagnosis of Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) recruited at the referral center, together with age- and sex-matched neurotypical healthy controls recruited from the same geographical area.

Ages

3 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * (I) PANS diagnosis made according to 2010 NIH criteria Exclusion Criteria (for the PANS group): * (I) onset of specific rheumatologic or immunologic diseases; * (II) presence of a diagnosed cancer or other severe medical illnesses; * (III) active treatment with steroidal or non-steroidal anti-inflammatory drugs The control group must include children without autoimmune diseases, neurodevelopmental or psychiatric disorders, and with adequate academic performance and functional level.

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Conditions

The condition(s) this trial relates to.

Neuroinflammatory Diseases pediatric acute-onset neuropsychiatric syndrome sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PANS Pediatric acute-onset neuropsychiatric syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Gaetano Martino

    RECRUITING

    Messina, Messina, 98124, Italy

  • Centro di Medicina del Sonno, SC Neurologia, AOU Cagliari

    ACTIVE_NOT_RECRUITING

    Cagliari, Cagliari, 09042, Italy

  • Dipartimento di Scienze Psicologiche, Pedagogiche, dell¿Esercizio Fisico e della Formazione

    ACTIVE_NOT_RECRUITING

    Palermo, Palermo, 90128, Italy

  • UOC Neuropsichiatria

    ACTIVE_NOT_RECRUITING

    Troina, Enna, 94018, Italy

  • Università degli Studi eCampus

    ACTIVE_NOT_RECRUITING

    Novedrate, CO, 22060, Italy

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