Autism Spectrum DisorderNCT04706364
Investigation of Brain Plasticity in Autism Spectrum Disorders
An observational study of Autism Spectrum Disorder, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Individuals with autism spectrum disorders (ASD) commonly experience variances in tactile behaviors, such as hypersensitivity to light touch stimuli, altered texture discrimination, and hyporesponsivity to pain. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Neuropsychological Testing, (Optional) Saliva Collection and Sensory Testing
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2019to May 2022
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children diagnosed with an Autism Spectrum Disorder (ASD), as well as controls.
Who may be able to join
- For ASD group:
- Clinical diagnosis of a disorder on the autism spectrum according to:
- DSM-IV or DSM 5 criteria
- IQ>70 (as determined by the Abbreviated Stanford-Binet IQ)
- For the Control group:
- No history of ASD or other developmental delay
- No history of ASD or other developmental delay in first-degree relatives.
- No history of clinical diagnosis of an anxiety disorder
Who cannot join
- Both ASD and Control groups:
- Intracranial pathology, cerebral palsy, history of severe head injury, or syndromic dysmorphology
- History of fainting spells of unknown or undetermined etiology that might constitute seizure
- History of seizure or epilepsy
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency
- Metal implants (excluding dental fillings) or devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible MD
Show all 11Show fewer
- Substance abuse or dependence within the past six months
- Chronic treatment with prescription medications that decrease cortical seizure threshold
- Peripheral neuropathy, as determined by the study MD during neurologic exam
- For the Control group:
- For control participants' medical history will be reviewed for diagnoses of neurologic or psychiatric disease. If in the judgment of the investigator, the condition, e.g., depression, is well-controlled with stable medications, and does not include abnormalities of the sensory motor systems, they may be included in the study. Control participants will be excluded from taking part in the study if they have a 1st degree relative with ASD.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Paul MacMullin, 617-355-4875, Paul.MacMullin@childrens.harvard.edu
Alexander Rotenberg, MD, PHD
About this study
Official title: Investigations of Sensorimotor Plasticity in Autism Spectrum Disorders
Individuals with autism spectrum disorders (ASD) commonly experience variances in tactile behaviors, such as hypersensitivity to light touch stimuli, altered texture discrimination, and hyporesponsivity to pain. Researchers aim to investigate the somatosensory sensitivity and sensorimotor integration utilizing novel, objective behavioral assays and TMS. The main purpose is to study brain plasticity (the changes that occur in the brain through experience) in individuals with autism spectrum disorders.
Read the detailed description
Individuals with autism spectrum disorders (ASD) commonly experience variances in tactile behaviors, such as hypersensitivity to light touch stimuli, altered texture discrimination and hyporesponsivity to pain. The degree of this somatosensory impairment correlates with increased anxiety behaviors as well as impairments in social behavior among ASD patients.
There remains an unmet need for suppressing the tactile hypersensitivity, which may improve anxiety and other core symptoms of ASD; however, methodologies for measuring tactile sensitivity vary widely across clinical and basic research fields. There is an urgent need for direct and objective sensory reactivity metrics in clinical studies to assess deficits in specific patient populations and for designing effective therapeutic strategies. As compared with traditional behavioral methods, the investigators propose to test novel, objective and quantitative metrics of somatosensory sensitivity in individuals with ASD.
In addition, transcranial magnetic stimulation (TMS) provides a method of measuring cortical reactivity offering the advantage of providing behaviorally independent results that are largely unaffected by attention or cognitive ability. Therefore, a TMS-based physiologic biomarker may be applicable to all individuals across the autism spectrum. A form of TMS known as paired associative stimulation (PAS) can be used to study the suggested impairment in integration of sensory input into cortical function that underlies tactile hypersensitivity in ASD. Thus, the investigators aim to investigate somatosensory sensitivity and sensorimotor integration utilizing novel, objective behavioral assays and TMS.
Participation in the study will consist of up to seven visits: one screening visit, two sensory testing visits, and two - four TMS sessions. The screening visit is expected to last between 2-3 hours, during which participants will first provide informed consent. Participants will then receive a thorough medical examination by a neurologist, and a neuropsychological evaluation (including IQ measures and ASD specific evaluations). If eligible to continue, participants will then come back for two sensory visits and two - four TMS visits that are spaced a minimum of 1 week apart.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Neuropsychological Testing, (Optional) Saliva Collection, Sensory Testing, Electroencephalogram (EEG), Transcranial Magnetic Stimulation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological TestingBehavioural
Includes an IQ test, Autism Diagnostic Observation Schedule-2 (ADOS-2), and Autism Diagnostic Interview-Revised (ADI-R) assessments.
(Optional) Saliva CollectionGenetic
The sample is to test for genes (BDNF/APOE/COMT) that everyone has, but people have different varieties of these genes.
Genetic testing is funded by Boston Children's Hospital.
Sensory TestingDevice
Three different tests will be completed:
the tactile prepulse inhibition test (PPI) texture perception indentation testing (Mechanical Detection Threshold).
Investigators will also apply mild electrical stimulation to the median nerve of the hand (on the wrist).
The second sensory visit will be another version of the PPI testing involving hearing and sound.
Electroencephalogram (EEG)Device
A cap will be placed on the participants head that will be filled with electrodes (small discs). The EEG will allow investigators to measure how the brain reacts to the sensory testing.
Transcranial Magnetic StimulationDevice
Single pulses of TMS, as well as PAS (a second type of TMS), will be applied to the cortex.
There will be two - four identical TMS testing visits.
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder (ASD) | Individuals diagnosed with an Autism Spectrum Disorder Receives: Behavioral: Neuropsychological Testing; Genetic: (Optional) Saliva Collection; Device: Sensory Testing; Device: Electroencephalogram (EEG); Device: Transcranial Magnetic Stimulation | |
| Healthy Control | Typically developing individuals without a history of autism Receives: Behavioral: Neuropsychological Testing; Genetic: (Optional) Saliva Collection; Device: Sensory Testing; Device: Electroencephalogram (EEG); Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Textured novel object recognition test (NORT) and mechanical detection threshold (MDT) with von Frey hairs
To assess the validity of tactile prepulse inhibition (PPI) and other quantitative somatosensory assessments as potential biomarkers for somatosensory dysfunction in children with ASD. These metrics will provide a valuable comparison to the more-quantitative physiological measures by PAS and PPI.
Measured: 3 years
Somatosensory temporal discrimination threshold (STDT) and PAS-induced modulation of motor-evoked potentials (MEPs)
To assess the validity of PAS-induced modulation of corticospinal excitability as a neurophysiologic biomarker for somatosensory dysfunction in children with ASD.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start10 Jun 2019
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Boston Children's 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Simons Foundation Autism Research Initiative (SFARI)
- Responsible party
- Principal investigator, Alexander Rotenberg, Boston Children's Hospital
- Investigators
- Alexander Rotenberg, MD, PhD, Principal investigator, Alexander.Rotenberg@childrens.harvard.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706364
- Sponsor's protocol ID
- IRB-P00027556
- Other IDs
- R21MH120438
- Status last verified
- Nov 2021
- First submitted
- 11 Jan 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations of Sensorimotor Plasticity in Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT04706364
- Acronym / sponsor ID
- IRB-P00027556
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Simons Foundation Autism Research Initiative (SFARI)
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 12 Jan 2021 (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.
Individuals with autism spectrum disorders (ASD) commonly experience variances in tactile behaviors, such as hypersensitivity to light touch stimuli, altered texture discrimination, and hyporesponsivity to pain. Researchers aim to investigate the somatosensory sensitivity and sensorimotor integration utilizing novel, objective behavioral assays and TMS. The main purpose is to study brain plasticity (the changes that occur in the brain through experience) in individuals with autism spectrum disorders.
Detailed description
Individuals with autism spectrum disorders (ASD) commonly experience variances in tactile behaviors, such as hypersensitivity to light touch stimuli, altered texture discrimination and hyporesponsivity to pain. The degree of this somatosensory impairment correlates with increased anxiety behaviors as well as impairments in social behavior among ASD patients.
There remains an unmet need for suppressing the tactile hypersensitivity, which may improve anxiety and other core symptoms of ASD; however, methodologies for measuring tactile sensitivity vary widely across clinical and basic research fields. There is an urgent need for direct and objective sensory reactivity metrics in clinical studies to assess deficits in specific patient populations and for designing effective therapeutic strategies. As compared with traditional behavioral methods, the investigators propose to test novel, objective and quantitative metrics of somatosensory sensitivity in individuals with ASD.
In addition, transcranial magnetic stimulation (TMS) provides a method of measuring cortical reactivity offering the advantage of providing behaviorally independent results that are largely unaffected by attention or cognitive ability. Therefore, a TMS-based physiologic biomarker may be applicable to all individuals across the autism spectrum. A form of TMS known as paired associative stimulation (PAS) can be used to study the suggested impairment in integration of sensory input into cortical function that underlies tactile hypersensitivity in ASD. Thus, the investigators aim to investigate somatosensory sensitivity and sensorimotor integration utilizing novel, objective behavioral assays and TMS.
Participation in the study will consist of up to seven visits: one screening visit, two sensory testing visits, and two - four TMS sessions. The screening visit is expected to last between 2-3 hours, during which participants will first provide informed consent. Participants will then receive a thorough medical examination by a neurologist, and a neuropsychological evaluation (including IQ measures and ASD specific evaluations). If eligible to continue, participants will then come back for two sensory visits and two - four TMS visits that are spaced a minimum of 1 week apart.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder (ASD) | – | Behavioral: Neuropsychological Testing, Genetic: (Optional) Saliva Collection, Device: Sensory Testing, Device: Electroencephalogram (EEG), Device: Transcranial Magnetic StimulationIndividuals diagnosed with an Autism Spectrum Disorder |
| Healthy Control | – | Behavioral: Neuropsychological Testing, Genetic: (Optional) Saliva Collection, Device: Sensory Testing, Device: Electroencephalogram (EEG), Device: Transcranial Magnetic StimulationTypically developing individuals without a history of autism |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children diagnosed with an Autism Spectrum Disorder (ASD), as well as controls.
Key inclusion criteria (8 listed)
- For ASD group:
- For the Control group:
Key exclusion criteria (11 listed)
- Both ASD and Control groups:
- For the Control group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological TestingIncludes an IQ test, Autism Diagnostic Observation Schedule-2 (ADOS-2), and Autism Diagnostic Interview-Revised (ADI-R) assessments. | Behavioural | Autism Spectrum Disorder (ASD), Healthy Control |
| (Optional) Saliva CollectionThe sample is to test for genes (BDNF/APOE/COMT) that everyone has, but people have different varieties of these genes. Genetic testing is funded by Boston Children's Hospital. | Genetic | Autism Spectrum Disorder (ASD), Healthy Control |
| Sensory TestingThree different tests will be completed: the tactile prepulse inhibition test (PPI) texture perception indentation testing (Mechanical Detection Threshold). Investigators will also apply mild electrical stimulation to the median nerve of the hand (on the wrist). The second sensory visit will be another version of the PPI testing involving hearing and sound. | Device | Autism Spectrum Disorder (ASD), Healthy Control |
| Electroencephalogram (EEG)A cap will be placed on the participants head that will be filled with electrodes (small discs). The EEG will allow investigators to measure how the brain reacts to the sensory testing. | Device | Autism Spectrum Disorder (ASD), Healthy Control |
| Transcranial Magnetic StimulationSingle pulses of TMS, as well as PAS (a second type of TMS), will be applied to the cortex. There will be two - four identical TMS testing visits. | Device | Autism Spectrum Disorder (ASD), Healthy Control |
Primary outcome
Textured novel object recognition test (NORT) and mechanical detection threshold (MDT) with von Frey hairs
Time frame: 3 years
To assess the validity of tactile prepulse inhibition (PPI) and other quantitative somatosensory assessments as potential biomarkers for somatosensory dysfunction in children with ASD. These metrics will provide a valuable comparison to the more-quantitative physiological measures by PAS and PPI.
Somatosensory temporal discrimination threshold (STDT) and PAS-induced modulation of motor-evoked potentials (MEPs)
Time frame: 3 years
To assess the validity of PAS-induced modulation of corticospinal excitability as a neurophysiologic biomarker for somatosensory dysfunction in children with ASD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
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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.
Alexander Rotenberg, MD, PhD principal investigator
Alexander.Rotenberg@childrens.harvard.edu
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 Autism Spectrum Disorder, run by Boston Children's Hospital 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 11 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: status not confirmed, as of the sponsor's last update on 5 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul MacMullin (617-355-4875, Paul.MacMullin@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Textured novel object recognition test (NORT) and mechanical detection threshold (MDT) with von Frey hairs (time frame: 3 years). The study lists 2 primary outcomes in all. 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 5 Nov 2021.