Recruiting

Brain Plasticity

Sponsor:

Boston Children's Hospital

Code:

NCT04706364

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Accepted

Interventions

Neuropsychological Testing

(Optional) Saliva Collection

Sensory Testing

Electroencephalogram (EEG)

Transcranial Magnetic Stimulation

Study Details

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.

Conditions

Autism Spectrum Disorder

Study ID

NCT04706364

Start date

Jun 10, 2019

Status verified date

Nov, 2021

Completion date

May, 2022

Anticipated

Primary completion date

May, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

  • For ASD group:

  • Clinical diagnosis of a disorder on the autism spectrum according to:

1. DSM-IV or DSM 5 criteria
2. 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Autism Spectrum Disorder (ASD)

Individuals diagnosed with an Autism Spectrum Disorder

Healthy Control

Typically developing individuals without a history of autism

Interventions

Neuropsychological Testing

Includes an IQ test, Autism Diagnostic Observation Schedule-2 (ADOS-2), and Autism Diagnostic Interview-Revised (ADI-R) assessments.

(Optional) Saliva Collection

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 Testing

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)

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 Stimulation

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.

Primary outcome measure

  • Textured novel object recognition test (NORT) and mechanical detection threshold (MDT) with von Frey hairs [ Time Frame: 3 years ]
  • Somatosensory temporal discrimination threshold (STDT) and PAS-induced modulation of motor-evoked potentials (MEPs) [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Paul MacMullin

617-355-4875Paul.MacMullin@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Paul MacMullin

617-355-4875Paul.MacMullin@childrens.harvard.edu

Principal Investigator:

Alexander Rotenberg, MD, PHD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Nov 5, 2021

Last verified

Nov, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2021-11-05.