Transcranial Magnetic Stimulation Studies in Autism Spectrum Disorders

NCT02591446 | Completed DMC

• 1 other identifier: 413114
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Autism Spectrum Disorder (ASD) is the most prevalent of the developmental disorders and their incidence is rising. However, the variability in the behavioral symptoms is large. In part for these reasons, the ASD clinical diagnosis is challenging and often is not made until 3-5 years of age. Thus, there remains an unmet need for a valid and reliable marker which would facilitate ASD diagnosis early in life, enable efficient study of ASD risk factors, and eventually serve as a useful marker to inform the development of effective therapies and assess treatment response in future clinical trials. The specific brain based marker that investigators are currently evaluating is brain plasticity (the changes that occur in your brain through experience). Investigators measure brain plasticity using noninvasive brain stimulation including transcranial magnetic stimulation (TMS) combined with brain imaging, EEG, and behavioral outcome measures. Their work to date demonstrates the potential utility of these techniques in higher-functioning adolescents and adults with ASD, and pilot data support the feasibility and safety of applying the same measures to children and lower functioning individuals. In this study, investigators will evaluate the validity of this marker in low- and high-functioning adults with ASD, in low- and high-functioning children with ASD, and assess the reliability of this marker.

Conditions

Autism Spectrum Disorder; Intellectual Disability

Keywords

TMS; Autism Spectrum Disorders; Plasticity

Outcome Measures

Primary Outcomes (1)

• Motor Evoked Potential

  Motor Evoked Potential will be assessed using electromyogram (EMG). The computer data will be de-identified.

  Immediately following TMS Motor Threshold determination.

Eligibility Criteria

• Age: 6 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We will study a total of 120 individuals with ASD. We will also evaluate a total of 120 controls. Ages 6 - 45

You may qualify if:

• For ASD group: Clinical diagnosis of a disorder on the autism spectrum according to:
• DSM 5 criteria
• Assessment using the Autism Diagnostic Interview-Revised
• Autism Diagnostic Observation Schedule.
• For the Control group:
• No history of ASD or other developmental delay
• No history of ASD or other developmental delay in first degree relatives.
• For the group of individuals with Intellectual Disability: Mild to moderate intellectual disability with IQ \< 70, but with no ASD.
• Age range: 6-45
• IQ: High functioning individuals will have an IQ\>90; Low functioning individuals will have an IQ \< 70 with mild-moderate intellectual disability.
• Informed consent (and if needed parental assent).

You may not qualify if:

• Intracranial pathology, cerebral palsy, history of severe head injury, or significant dysmorphology;
• History of fainting spells of unknown or undetermined etiology that might constitute seizures;
• History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy;
• Any progressive (e.g., neurodegenerative) neurological disorder;
• Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.);
• Metal implants (excluding dental fillings);
• Pacemaker;
• Implanted medication pump;
• Vagal nerve stimulator;
• Deep brain stimulator;
• TENS unit (unless removed completely for the study);
• Ventriculo-peritoneal shunt;
• Signs of increased intracranial pressure;
• Intracranial lesion (including incidental finding on MRI);
• History of head injury resulting in prolonged loss of consciousness;

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Nancy Lurie Marks Family Foundation: collaborator
• Bradley Hospital: collaborator

Study Sites (1)

Bradley Hospital

East Providence, Rhode Island, 02915, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Intellectual Disability

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lindsay Oberman, PhD

  Lifespan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 29, 2015
• Study Start: October 1, 2014
• Primary Completion: August 7, 2017
• Study Completion: August 7, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-04

Locations

US (1)