Investigation of Brain Plasticity in Autism Spectrum Disorders
Investigations of Sensorimotor Plasticity in Autism Spectrum Disorders
2 other identifiers
observational
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2019
CompletedFirst Submitted
Initial submission to the registry
January 11, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedNovember 5, 2021
November 1, 2021
2.9 years
January 11, 2021
November 4, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
3 years
Study Arms (2)
Autism Spectrum Disorder (ASD)
Individuals diagnosed with an Autism Spectrum Disorder
Healthy Control
Typically developing individuals without a history of autism
Interventions
Includes an IQ test, Autism Diagnostic Observation Schedule-2 (ADOS-2), and Autism Diagnostic Interview-Revised (ADI-R) assessments.
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.
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.
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.
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.
Eligibility Criteria
Children diagnosed with an Autism Spectrum Disorder (ASD), as well as controls.
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Biospecimen
Saliva sample for genetic testing (optional)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Rotenberg, MD, PhD
Alexander.Rotenberg@childrens.harvard.edu
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Neurology
Study Record Dates
First Submitted
January 11, 2021
First Posted
January 12, 2021
Study Start
June 10, 2019
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
November 5, 2021
Record last verified: 2021-11