Neurodevelopmental DisordersNCT06213090
Patterns of Neurodevelopmental Disorders
An observational study of Neurodevelopmental Disorders and Autism Spectrum Disorder, run by Richard Frye at 1 site in United States.
Trial summary
The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infection
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 31 Dec 2030
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children who present to Rossignol Medical Center for standard care related to neurodevelopmental disorders.
Who may be able to join
- Neurodevelopmental delays Clinical visit at an Rossignol Medical Center
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rossignol Medical Center
Phoenix, Arizona, 85050
Richard E Frye, MD, PhD, 281-546-8377, drfrye@rossignolmedicalcenter.com
About this study
Official title: Patterns of Disease, Outcomes and Treatment Response in Children With Neurodevelopmental Disorders
The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.
Read the detailed description
Although neurodevelopmental disorders are very prevalent (for example Autism affects 1 out of every 36 children and dyslexia affects up to 15% of the population), the etiology of such disorders is not known. The purpose of this investigation is to identify common etiologies of neurodevelopmental disorders (i.e., speech delay, global developmental delay, autism) and determine if it is possible to find early indicators of the diagnosis and foster the potential for a better prognosis of these disorders. At this time the investigators examine patients with neurodevelopment disorders with various medical investigations, but the results of these investigations are not systematically evaluated. One of the goals of this research is to systematically examine this information in order to identify patterns of test abnormalities that have not been previously described. Another goal of this research is to identify the common etiologies typically identified by the medical evaluation, so we can further refine our approach. In addition, the investigators now have the ability to evaluate biological samples for biomarkers that have potential to be diagnostically useful.
- Conditions
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infection, Pediatric Acute-Onset Neuropsychiatric Syndrome, Down Syndrome, Epilepsy
- Medical subject headings
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections, Pediatric acute-onset neuropsychiatric syndrome, Down Syndrome, Epilepsy, Mitochondrial Encephalomyopathies, Neurodegeneration Due To Cerebral Folate Transport Deficiency
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 |
|---|---|---|
| Autism | Children with autism will be followed in regards to their clinical management. | |
| Mitochondrial Encephalopathy | Children with Mitochondrial Encephalopathy will be followed in regards to their clinical management. | |
| Down Syndrome | Children with Down Syndrome will be followed in regards to their clinical management. | |
| Cerebral Folate Deficiency | Children with Cerebral Folate Deficiency will be followed in regards to their clinical management. | |
| PANS | Children with PANS will be followed in regards to their clinical management. | |
| PANDAS | Children with PANDAS will be followed in regards to their clinical management. | |
| Epilepsy | Children with Epilepsy will be followed in regards to their clinical management. | |
| ADHD | Children with ADHD will be followed in regards to their clinical management. | |
| Dyslexia and other learning disabilities | Children with Dyslexia and other learning disabilities will be followed in regards to their clinical management. | |
| Other Neurodevelopmental Disorders | Children with Other Neurodevelopmental Disorders will be followed in regards to their clinical management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Specific Medical abnormalities
It is unknown if a specific set of biological abnormalities contribute to the formation of many types of neurodevelopmental disorders. The study is intended to identify the relationship between biological abnormalities and neurodevelopmental disorders. The chart will be reviewed for medical diagnoses other than the primary neurodevelopmental disorders.
Measured: up to 7 years
Secondary outcomes (2)
The number of children with abnormal clinical lab
It is unknown if a abnormalities in specific clinical laboratories are associated with specific neurodevelopmental disorders. The study is intended to identify the relationship between biological abnormalities and neurodevelopmental disorders. The medical chart will be reviewed to determine the number of children with a specific medical disorder who have abnormalities in specific clinical labs.
Measured: up to 7 years
The number of children who respond to specific treatments
Various behavioral and medical treatments are used for many types of neurodevelopmental disorders but the effectiveness for many of these treatments is not known. The study is intended to identify the relationship between biological abnormalities (and their treatments) and neurodevelopmental disorders. The medical chart will be review to determine the treatments applied to each participant and the participants response.
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richard Frye
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Discovery and Treatment Foundation
- Responsible party
- Sponsor-investigator, Richard Frye, Rossignol Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213090
- Sponsor's protocol ID
- NeuroClinical
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified IPD may be shared on a case by case basis
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Disease, Outcomes and Treatment Response in Children With Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT06213090
- Acronym / sponsor ID
- NeuroClinical
- Conditions
- Neurodevelopmental Disorders, Autism Spectrum Disorder, Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infection, Pediatric Acute-Onset Neuropsychiatric Syndrome, Down Syndrome, Epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Richard FryeUniversity, hospital or other
- Collaborators
- Autism Discovery and Treatment Foundation
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 19 Jan 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 purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.
Detailed description
Although neurodevelopmental disorders are very prevalent (for example Autism affects 1 out of every 36 children and dyslexia affects up to 15% of the population), the etiology of such disorders is not known. The purpose of this investigation is to identify common etiologies of neurodevelopmental disorders (i.e., speech delay, global developmental delay, autism) and determine if it is possible to find early indicators of the diagnosis and foster the potential for a better prognosis of these disorders. At this time the investigators examine patients with neurodevelopment disorders with various medical investigations, but the results of these investigations are not systematically evaluated. One of the goals of this research is to systematically examine this information in order to identify patterns of test abnormalities that have not been previously described. Another goal of this research is to identify the common etiologies typically identified by the medical evaluation, so we can further refine our approach. In addition, the investigators now have the ability to evaluate biological samples for biomarkers that have potential to be diagnostically useful.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Autism | – | –Children with autism will be followed in regards to their clinical management. |
| Mitochondrial Encephalopathy | – | –Children with Mitochondrial Encephalopathy will be followed in regards to their clinical management. |
| Down Syndrome | – | –Children with Down Syndrome will be followed in regards to their clinical management. |
| Cerebral Folate Deficiency | – | –Children with Cerebral Folate Deficiency will be followed in regards to their clinical management. |
| PANS | – | –Children with PANS will be followed in regards to their clinical management. |
| PANDAS | – | –Children with PANDAS will be followed in regards to their clinical management. |
| Epilepsy | – | –Children with Epilepsy will be followed in regards to their clinical management. |
| ADHD | – | –Children with ADHD will be followed in regards to their clinical management. |
| Dyslexia and other learning disabilities | – | –Children with Dyslexia and other learning disabilities will be followed in regards to their clinical management. |
| Other Neurodevelopmental Disorders | – | –Children with Other Neurodevelopmental Disorders will be followed in regards to their clinical management. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children who present to Rossignol Medical Center for standard care related to neurodevelopmental disorders.
Key inclusion criteria (1 listed)
- Neurodevelopmental delays Clinical visit at an Rossignol Medical Center
Key exclusion criteria (1 listed)
- -
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
Number of Patients with Specific Medical abnormalities
Time frame: up to 7 years
It is unknown if a specific set of biological abnormalities contribute to the formation of many types of neurodevelopmental disorders. The study is intended to identify the relationship between biological abnormalities and neurodevelopmental disorders. The chart will be reviewed for medical diagnoses other than the primary neurodevelopmental disorders.
2 secondary outcomes
The number of children with abnormal clinical lab
Time frame: up to 7 years
The number of children who respond to specific treatments
Time frame: up to 7 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 16 Apr 2026.
- Rossignol Medical CenterLink provided by the sponsor.
- Autism Discovery and Treatment FoundationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Deidentified IPD may be shared on a case by case basis
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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.
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 Neurodevelopmental Disorders and Autism Spectrum Disorder, run by Richard Frye 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 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: looking for participants now, as of the sponsor's last update on 16 Apr 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Specific Medical abnormalities (time frame: up to 7 years). 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 2026.