Effect of rTMS on the Abnormal Executive Function of ASD Children

Last updated: January 22, 2020
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04237870
XH-19-013
  • Ages 6-16
  • All Genders

Study Summary

In this study, the investigators will explore the effects of repetitive transcranial magnetic stimulation (rTMS) on executive function deficits in high function autism spectrum disorder. Half of the participants will be chosen by chance to receive continuous theta burst stimulation (cTBS) while the other half will be chosen by chance to receive sham stimulation. And finally the sham group individuals also receive cTBS. Based on results from a recent unpublished pilot data, the investigators propose that cTBS treatment will induce a significant improvement in executive function performance compared to sham treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with ASD. Diagnostic criteria: diagnosed by pediatric psychiatristsin accordance with the criteria in the Fifth Edition of Diagnostic and StatisticalManual of Mental Disorders (DSM-V), Autism Diagnostic Observation Schedule (ADOS) andAutism Diagnostic Interview-Revised (ADI-R);

  • Have a diagnosis of high functioning ASD (HF-ASD) (i.e., are verbal with anIntelligence Quotient (IQ) ≥ 70)

  • Are clinically stable as determined by their treating physician, with no medicationchanges over the past 4 weeks

Exclusion

Exclusion Criteria:

  • Have metal or electronic instruments near the stimulation brain area of coil, such as,have intravascular stent in head, have metal objects in skull.

  • Have cardiac pacemaker, cochlear implant, medical pump;

  • Can not cooperate with examiner;

  • Have intracranial foreign bodies by craniotomy, or intracranial deformity

  • Have a history of substance abuse or dependence in the last 6 months or have apositive urine toxicology screen

  • Have a concomitant major medical or neurologic illness

  • Have had a seizure in the past, or have a first-degree relative with epilepsy

  • Have an abnormal clinical EEG

  • Are pregnant or likely to get pregnant during the next 4 weeks

  • Have a history of rTMS treatment.

Study Design

Total Participants: 40
Study Start date:
January 01, 2019
Estimated Completion Date:
September 30, 2021

Study Description

This study is a randomized, sham controlled study to evaluate the efficacy of cTBS as a treatment for executive function deficits in individuals with autism spectrum disorder between 6 and 16 years of age. The study duration is approximately 1 months, with the cTBS sessions lasting for 4 weeks, 5 times a week, for about 20min each. Several scales will be used to assess for symptom severity and adaptive functioning. The executive function will be evaluated by Behaviour Rating Inventory of Executive Functioning (BRIEF) questionnaire. Cognition will be assessed using functional near - infrared spectroscopy (fNIRS).

This study also involves a type of brain imaging known as magnetic resonance imaging (MRI) at the beginning and at the end of the 4 weeks daily cTBS to better understand the effects of cTBS on brain structure and function. Investigators will measure the size and connections of different parts of the brain to assess brain structure and blood flow.

Connect with a study center

  • Fei Li

    Shanghai, Shanghai 200092
    China

    Active - Recruiting

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