Autism Spectrum DisordersNCT01361503
Magnetic Resonance Spectroscopic and Diffusion Tensor Imaging of Adolescents with Autism Spectrum Disorders
An observational study of Autism Spectrum Disorders, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The primary objective of this study is to conduct magnetic resonance spectroscopic (MRS) and imaging (MRI) scans to assess the structural and neurochemical profile of the brain in 20 children and adolescents, 6-17 years old with Autism Spectrum Disorder (ASD). Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Sep 2014
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects will be recruited from current patients of The Alan and Lorraine Bressler Clinic for Autism Spectrum Disorders. We propose to contact by letter (via regular mail or email) or telephone patients who have been identified by clinicians as expressing interest in the study. Subjects who have participated in previous protocols in our program may also be eligible to participate in this study. We propose to contact by letter or telephone past study participants who have expressed interested in being contacted about future studies they may be eligible for in our office. If a potential subject's clinician ascertains that the patient has an interest in study participation, the clinician will only offer contact information for the study to the patient and/or the patient's parents. The patient and/or parent can then contact the study coordinator for more information on the actual study.
Who may be able to join
- Male or female participants between 6 and 17 years of age.
- Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria for autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical interview.
- Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- Subjects and their legal representative must be considered reliable reporters.
- Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative and the subject must sign an IRB approved informed consent and assent document respectively.
- Participants with disruptive behavior disorders, mood and anxiety disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.
Who cannot join
- IQ < 85.
- DSM-IV-TR PDD diagnoses of Rett's disorder, or childhood disintegrative disorder.
- Current diagnosis of a psychotic disorder or unstable bipolar disorder.
- History of recent or current (past 30 days) clinically significant depressive or anxiety disorder that warrants treatment.
- History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse.
- Clinically unstable psychiatric conditions or judged to be at serious safety risk to self (suicidal risk) or others.
Show all 14Show fewer
- Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
- Organic brain disorders.
- History of non-febrile seizures without a clear and resolved etiology in last 1 month.
- Pregnant or nursing females.
- Left hand dominant subjects.
- History of claustrophobia or fear of enclosed places.
- Presence of metal or surgical devices (aneurysm clips, metal plates, cochlear implants, neurostimulators, braces, and other items).
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McLean Hospital
Belmont, Massachusetts, 02478
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The primary objective of this study is to conduct magnetic resonance spectroscopic (MRS) and imaging (MRI) scans to assess the structural and neurochemical profile of the brain in 20 children and adolescents, 6-17 years old with Autism Spectrum Disorder (ASD). For comparison, MRS and MRI will also be obtained from 10 healthy control subjects, matched to the 20 subjects with ASD in age, sex, dexterity, and IQ. All eligible subjects will be administered a detailed assessment battery consisting of cognitive assessments (neuropsychological battery including subsets of the DANVA2 and the CANTAB) and measures of psychosocial functioning (SAICA and M-FES). The study includes 1-3 visits for the screening period at Massachusetts General Hospital (approximately 4 hours of assessments) and one scanning visit at McLean Hospital (approximately 1.5 hours).
The investigators hypothesize that youth with ASD versus controls will exhibit increased glutamate concentrations, reflecting glutamatergic overactivity, and increased Cho concentrations, suggesting neuronal abnormality. Furthermore, the investigators hypothesize that compared to neurotypical controls, the structural integrity of white mater tracts will be disrupted in ASD.
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism Spectrum Disorders, Pervasive Developmental Disorders, Asperger's Syndrome, Adolescents, Magnetic Resonance Spectroscopy, Diffusion Tensor Imaging
- Medical subject headings
- Autism Spectrum Disorder, Child Development Disorders, Pervasive, Asperger Syndrome
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 Spectrum Disorder (ASD) | Not described | |
| Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural and neurochemical profiles of adolescents with ASD
Concentrations of various neurochemicals, including glutamate, will be examined in addition to the structural integrity of white matter tracts. These results will be compared to results from control subjects.
Measured: scanning visit (1.5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startApr 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mclean Hospital
- Responsible party
- Principal investigator, Gagan Joshi, Massachusetts General Hospital
- Investigators
- Gagan Joshi, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361503
- Sponsor's protocol ID
- 2010-P-000185
- Status last verified
- Dec 2024
- First submitted
- 19 Nov 2010
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Spectroscopic and Diffusion Tensor Imaging of Adolescents with Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01361503
- Acronym / sponsor ID
- 2010-P-000185
- Conditions
- Autism Spectrum Disorders
- Keywords
- Autism Spectrum Disorders, Pervasive Developmental Disorders, Asperger's Syndrome, Adolescents, Magnetic Resonance Spectroscopy, Diffusion Tensor Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mclean Hospital
- Study start
- Apr 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 May 2011 (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 primary objective of this study is to conduct magnetic resonance spectroscopic (MRS) and imaging (MRI) scans to assess the structural and neurochemical profile of the brain in 20 children and adolescents, 6-17 years old with Autism Spectrum Disorder (ASD). For comparison, MRS and MRI will also be obtained from 10 healthy control subjects, matched to the 20 subjects with ASD in age, sex, dexterity, and IQ. All eligible subjects will be administered a detailed assessment battery consisting of cognitive assessments (neuropsychological battery including subsets of the DANVA2 and the CANTAB) and measures of psychosocial functioning (SAICA and M-FES). The study includes 1-3 visits for the screening period at Massachusetts General Hospital (approximately 4 hours of assessments) and one scanning visit at McLean Hospital (approximately 1.5 hours).
The investigators hypothesize that youth with ASD versus controls will exhibit increased glutamate concentrations, reflecting glutamatergic overactivity, and increased Cho concentrations, suggesting neuronal abnormality. Furthermore, the investigators hypothesize that compared to neurotypical controls, the structural integrity of white mater tracts will be disrupted in ASD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder (ASD) | – | – |
| Controls | – | – |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects will be recruited from current patients of The Alan and Lorraine Bressler Clinic for Autism Spectrum Disorders. We propose to contact by letter (via regular mail or email) or telephone patients who have been identified by clinicians as expressing interest in the study. Subjects who have participated in previous protocols in our program may also be eligible to participate in this study. We propose to contact by letter or telephone past study participants who have expressed interested in being contacted about future studies they may be eligible for in our office. If a potential subject's clinician ascertains that the patient has an interest in study participation, the clinician will only offer contact information for the study to the patient and/or the patient's parents. The patient and/or parent can then contact the study coordinator for more information on the actual study.
Key inclusion criteria (6 listed)
- Male or female participants between 6 and 17 years of age.
- Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria for autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical interview.
- Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- Subjects and their legal representative must be considered reliable reporters.
- Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative and the subject must sign an IRB approved informed consent and assent document respectively.
Key exclusion criteria (14 listed)
- IQ < 85.
- DSM-IV-TR PDD diagnoses of Rett's disorder, or childhood disintegrative disorder.
- Current diagnosis of a psychotic disorder or unstable bipolar disorder.
- History of recent or current (past 30 days) clinically significant depressive or anxiety disorder that warrants treatment.
- History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse.
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
Structural and neurochemical profiles of adolescents with ASD
Time frame: scanning visit (1.5 hours)
Concentrations of various neurochemicals, including glutamate, will be examined in addition to the structural integrity of white matter tracts. These results will be compared to results from control subjects.
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 13 Dec 2024.
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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.
Gagan Joshi, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorders, run by Massachusetts General Hospital at 2 sites 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 6 inclusion and 14 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 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Structural and neurochemical profiles of adolescents with ASD (time frame: scanning visit (1.5 hours)). 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 13 Dec 2024.