Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-18
SponsorStanford University

About this trial

This study is an investigation of the neurologic, immunologic, and rheumatologic markers of Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). PANS is a condition characterized by the abrupt, dramatic onset of obsessive compulsive disorder (OCD) and/or eating restriction accompanied by equally abrupt and severe co-morbid neuropsychiatric symptoms, which include anxiety, emotional lability, depression, irritability, aggression, oppositionality, deterioration in school performance, behavioral (developmental) regression, sensory amplification, movement abnormalities, sleep disturbance, and urinary frequency. PANS is thought to be caused by infection, inflammation, or alternate triggers that is associated with a brain response that leads to these symptoms. The purpose of this study is to examine specific neurologic, immunologic, rheumatologic, and genomic, components in children with the acute-onset of psychiatric symptoms. This research may begin to uncover a much larger story of autoimmune processes that are involved in psychiatric disorders of childhood. By better understanding the etiologic components of psychiatric phenomenon, future treatments may be better targeted to underlying causes.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children with PANS

Age 1-18 at onset of PANS

Diagnosis of PANS: abrupt onset of OCD or food restriction, and at least two of the following associated symptoms: frequent urination, worsening handwriting/cognition, inattention, anorexia, separation anxiety, oppositionality, irritability/rage outbursts, and emotional lability.

Patients must live within 90 miles of Stanford University and have a new onset of PANS illness

Disqualifiers

Any neuropsychiatric illness that may obscure the clear diagnosis of PANS

Trial population

The investigators to enroll 500 children with PANS/PANDAS and 100 healthy controls. Children's parents will also be enrolled to report information about their children as well as their own caregiver burden. The 500 patients with PANS will meet diagnostic criteria. These patients are targeted because this study is seeking to specifically assess the immunologic and neurological markers of PANS.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 2 trial groups
Group A: PANS group
Group B: Health Controls

Trial outcomes

Primary outcomes

1

Cerebral blood flow

The investigators will report results of altered cerebral blood flow from patients with PANS.

Time frame
Through study completion, up to 12 years
2

EEG patterns

The investigators will report results of abnormal EEG patterns from patients with PANS. All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.

Time frame
Through study completion, up to 12 years
3

Rapid Eye Movement (REM) motor disinhibition

The investigators will report results of REM motor disinhibition from polysomnography studies. All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.

Time frame
Through study completion, up to 12 years

Secondary outcomes

1

Global Impairment Scores

All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.

Time frame
Every 2-4 weeks for up to 12 years
2

Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.

Time frame
Every 2-4 weeks for up to 12 years
3

Columbia Impairment Scale

All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.

Time frame
Every 2-4 weeks for up to 12 years
4

Caregiver Burden Inventory

All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.

Time frame
Every 2-4 weeks for up to 12 years

Other outcomes

Sponsors and contacts

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