Neurodevelopmental DisordersNCT02003170
Etiology and Early Diagnosis of Neurodevelopmental Disorders
An observational study of Neurodevelopmental Disorders, run by University of Arkansas 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?
- Ages 0 months to 99 years
- Conditions the study is for
- Neurodevelopmental Disorders
- How many people
- 576 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 6 Jun 2024
- Phase
- Observational
- 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 0 months to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children who present to various Arkansas Children's Hospital Outpatient clinics for standard care related to neurodevelopmental disorders.
Who may be able to join
- Neurodevelopmental delays
- Clinical visit at an Arkansas Children's Hospital Outpatient clinic
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72205
About this study
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 88 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
- Keywords
- Autism, Autism Spectrum Disorder (ASD), Pervasive Developmental Disorder (PDD), Developmental delays, Genetic disorder, Mitochondrial disorder
- Medical subject headings
- Neurodevelopmental Disorders, Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Genetic Diseases, Inborn, Mitochondrial Diseases
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 |
|---|---|---|
| Neurodevelopmental Disorders | Children who present to various Arkansas Children's Hospital clinics for standard care related to neurodevelopmental disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical abnormalities associated with specific neurodevelopmental disorders
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
Measured: up to 7 years
Secondary outcomes (2)
Biomarkers associated with neurodevelopmental disorders
It is unknown if a specific biomarkers are associated with specific neurodevelopmental disorders. The study is intended to identify the relationship between biological abnormalities and neurodevelopmental disorders
Measured: up to 7 years
Treatments associated with neurodevelopmental disorders
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
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 posted6 Dec 2013 (estimated)
- Study startMay 2012
- Primary completion6 Jun 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Shannon Rose, PhD., Principal investigator, Arkansas Children's Hospital Research Instisute; UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003170
- Sponsor's protocol ID
- 136272
- Status last verified
- Jul 2024
- First submitted
- 25 Nov 2013
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Frye RE, Lionnard L, Singh I, Karim MA, Chajra H, Frechet M, Kissa K, Racine V, Ammanamanchi A, McCarty PJ, Delhey L, Tippett M, Rose S, Aouacheria A. Mitochondrial morphology is associated with respiratory chain uncoupling in autism spectrum disorder. Transl Psychiatry. 2021 Oct 13;11(1):527. doi: 10.1038/s41398-021-01647-6.
PubMed 34645790
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology and Early Diagnosis of Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT02003170
- Acronym / sponsor ID
- 136272
- Conditions
- Neurodevelopmental Disorders
- Keywords
- Autism, Autism Spectrum Disorder (ASD), Pervasive Developmental Disorder (PDD), Developmental delays, Genetic disorder, Mitochondrial disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 576 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Arkansas Children's Hospital Research Institute
- Study start
- May 2012
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 6 Dec 2013 (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.
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 88 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
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurodevelopmental Disorders | – | –Children who present to various Arkansas Children's Hospital clinics for standard care related to neurodevelopmental disorders. |
Who may qualify
- Ages
- 0 months to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children who present to various Arkansas Children's Hospital Outpatient clinics for standard care related to neurodevelopmental disorders.
Key inclusion criteria (2 listed)
- Neurodevelopmental delays
- Clinical visit at an Arkansas Children's Hospital Outpatient clinic
Key exclusion criteria (1 listed)
- none
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
Medical abnormalities associated with specific neurodevelopmental disorders
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
2 secondary outcomes
Biomarkers associated with neurodevelopmental disorders
Time frame: up to 7 years
Treatments associated with neurodevelopmental disorders
Time frame: up to 7 years
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 8 Jul 2024.
- Derived from this study: PubMed 34645790Frye RE, Lionnard L, Singh I, Karim MA, Chajra H, Frechet M, Kissa K, Racine V, Ammanamanchi A, McCarty PJ, Delhey L, Tippett M, Rose S, Aouacheria A. Mitochondrial morphology is associated with respiratory chain uncoupling in autism spectrum disorder. Transl Psychiatry. 2021 Oct 13;11(1):527. doi: 10.1038/s41398-021-01647-6.
- To see a list of current clinical Trials at Arkansas Children's Hospital, click here!!Link provided by the sponsor.
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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.
Shannon Rose, PhD. principal investigator
Arkansas Children's Hospital Research Instisute; UAMS
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, run by University of Arkansas 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 2 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 8 Jul 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 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?
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?
Medical abnormalities associated with specific neurodevelopmental disorders (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?
On the ClinicalTrials.gov record for NCT02003170, which also lists 1 linked publication.
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 8 Jul 2024.