Pediatric Acute-Onset Neuropsychiatric SyndromeNCT02889016
Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS
An observational study of Pediatric Acute-Onset Neuropsychiatric Syndrome and Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections, run by Stanford University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Acute-Onset Neuropsychiatric Syndrome, Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections, PANS
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study 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.
Who may be able to join
- 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
- Patients must have an established pediatrician within 90 miles of Stanford University for 3 years.
- Healthy Controls
- Age 4-18
- No psychiatric diagnosis
Who cannot join
- Any neuropsychiatric illness that may obscure the clear diagnosis of PANS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joanne Cheung contact
Ellen Spartz contact
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94305-5906
Joanne Cheung, pansresearch@stanford.edu
About this study
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.
Read the detailed description
The investigators will recruit 500 children, 1-18 years old at onset with PANS/PANDAS. They will be treatment naive and within one month of onset/exacerbation. The 500 children with PANS will be gender- and age-matched to 100 healthy children, to allow examination of immunologic, neurologic, genomic, and behavioral differences between these two groups of children.
- Conditions
- Pediatric Acute-Onset Neuropsychiatric Syndrome, Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections, PANS, PANDAS
- Keywords
- PANS, PANDAS
- Medical subject headings
- Pediatric acute-onset neuropsychiatric syndrome, Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PANS group | 500 children, 1-18 years old at onset with a strict diagnosis of PANS/PANDAS will be recruited | |
| Health Controls | 100 healthy children age- and gender- matched to the PANS group will be recruited |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
The investigators will report results of altered cerebral blood flow from patients with PANS.
Measured: Through study completion, up to 12 years
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.
Measured: Through study completion, up to 12 years
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.
Measured: Through study completion, up to 12 years
Secondary outcomes (5)
Global Impairment Scores
All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.
Measured: Every 2-4 weeks for up to 12 years
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.
Measured: Every 2-4 weeks for up to 12 years
Columbia Impairment Scale
All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.
Measured: Every 2-4 weeks for up to 12 years
Caregiver Burden Inventory
All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.
Measured: Every 2-4 weeks for up to 12 years
Neurological findings
The investigators will report data from neurological exam findings, including milk maid grip, chorea, choreiform movements of arms and legs, apraxia, overflow dystonia, truncal instability, piano-playing fingers, glabellar sign, etc. All data will be obtained through the review of medical records, which are created during the routine clinical care of patients. These results will be aggregated to report the number of participants with abnormal neurological findings.
Measured: Every 2-4 weeks for up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startMar 2013
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric Acute-Onset Neuropsychiatric SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Frankovich, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889016
- Sponsor's protocol ID
- 26922
- Status last verified
- Oct 2016
- First submitted
- 22 Aug 2016
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data is available upon request as allowed by the Stanford Institutional Review board.
Publications
Swedo SE, Leckman JF, Rose NR (2012) From Research Subgroup to Clinical Syndrome: Modifying the PANDAS Criteria to Describe PANS (Pediatric Acute-onset Neuropsychiatric Syndrome). Pediatr Therapeut 2:113. doi: 10.4172/2161-0665.1000113
Chang K, Frankovich J, Cooperstock M, Cunningham MW, Latimer ME, Murphy TK, Pasternack M, Thienemann M, Williams K, Walter J, Swedo SE; PANS Collaborative Consortium. Clinical evaluation of youth with pediatric acute-onset neuropsychiatric syndrome (PANS): recommendations from the 2013 PANS Consensus Conference. J Child Adolesc Psychopharmacol. 2015 Feb;25(1):3-13. doi: 10.1089/cap.2014.0084. Epub 2014 Oct 17.
PubMed 25325534Murphy TK, Gerardi DM, Leckman JF. Pediatric acute-onset neuropsychiatric syndrome. Psychiatr Clin North Am. 2014 Sep;37(3):353-74. doi: 10.1016/j.psc.2014.06.001.
PubMed 25150567
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS
- ClinicalTrials.gov ID
- NCT02889016
- Acronym / sponsor ID
- 26922
- Conditions
- Pediatric Acute-Onset Neuropsychiatric Syndrome, Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections, PANS, PANDAS
- Keywords
- PANS, PANDAS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 5 Sep 2016 (estimated)
- 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 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.
Detailed description
The investigators will recruit 500 children, 1-18 years old at onset with PANS/PANDAS. They will be treatment naive and within one month of onset/exacerbation. The 500 children with PANS will be gender- and age-matched to 100 healthy children, to allow examination of immunologic, neurologic, genomic, and behavioral differences between these two groups of children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PANS group | – | –500 children, 1-18 years old at onset with a strict diagnosis of PANS/PANDAS will be recruited |
| Health Controls | – | –100 healthy children age- and gender- matched to the PANS group will be recruited |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study 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.
Key inclusion criteria (8 listed)
- Children with PANS
- Healthy Controls
Key exclusion criteria (1 listed)
- Any neuropsychiatric illness that may obscure the clear diagnosis of PANS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cerebral blood flow
Time frame: Through study completion, up to 12 years
The investigators will report results of altered cerebral blood flow from patients with PANS.
EEG patterns
Time frame: Through study completion, up to 12 years
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.
Rapid Eye Movement (REM) motor disinhibition
Time frame: Through study completion, up to 12 years
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.
5 secondary outcomes
Global Impairment Scores
Time frame: Every 2-4 weeks for up to 12 years
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time frame: Every 2-4 weeks for up to 12 years
Columbia Impairment Scale
Time frame: Every 2-4 weeks for up to 12 years
Caregiver Burden Inventory
Time frame: Every 2-4 weeks for up to 12 years
Neurological findings
Time frame: Every 2-4 weeks for up to 12 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- BackgroundSwedo SE, Leckman JF, Rose NR (2012) From Research Subgroup to Clinical Syndrome: Modifying the PANDAS Criteria to Describe PANS (Pediatric Acute-onset Neuropsychiatric Syndrome). Pediatr Therapeut 2:113. doi: 10.4172/2161-0665.1000113
- Background: PubMed 25325534Chang K, Frankovich J, Cooperstock M, Cunningham MW, Latimer ME, Murphy TK, Pasternack M, Thienemann M, Williams K, Walter J, Swedo SE; PANS Collaborative Consortium. Clinical evaluation of youth with pediatric acute-onset neuropsychiatric syndrome (PANS): recommendations from the 2013 PANS Consensus Conference. J Child Adolesc Psychopharmacol. 2015 Feb;25(1):3-13. doi: 10.1089/cap.2014.0084. Epub 2014 Oct 17.
- Background: PubMed 25150567Murphy TK, Gerardi DM, Leckman JF. Pediatric acute-onset neuropsychiatric syndrome. Psychiatr Clin North Am. 2014 Sep;37(3):353-74. doi: 10.1016/j.psc.2014.06.001.
- Individual participant dataSharing planned: Yes. Data is available upon request as allowed by the Stanford Institutional Review board.
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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.
Joanne Cheung contact
Ellen Spartz contact
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 Pediatric Acute-Onset Neuropsychiatric Syndrome and Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections, run by Stanford University at 1 site in United States.
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 8 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: looking for participants now, as of the sponsor's last update on 6 Oct 2016. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanne Cheung (pansresearch@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (time frame: Through study completion, up to 12 years). 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?
On the ClinicalTrials.gov record for NCT02889016, which also lists 3 linked publications.
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 Oct 2016.