Clinical trial NCT04237870: Effect of rTMS on the Abnormal Executive Function of ASD Children
Official title: A Clinical Study to Explore the Effect of Repetitive Transcranial Magnetic Stimulation on Abnormal Executive Function of High Function Autism Spectrum Disorder Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Executive Dysfunction
ASD
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Based on results from a recent unpublished pilot data, the investigators propose that cTBS treatment will induce a significant improvement in executive function performance compared to sham treatment.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with ASD. Diagnostic criteria: diagnosed by pediatric psychiatrists in accordance with the criteria in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V), Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview-Revised (ADI-R);
* Have a diagnosis of high functioning ASD (HF-ASD) (i.e., are verbal with an Intelligence Quotient (IQ) ≥ 70)
* Are clinically stable as determined by their treating physician, with no medication changes over the past 4 weeks

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 a positive 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.

Primary outcomes:
measure: Change in scores on Behaviour Rating Inventory of Executive Functioning (BRIEF)
timeFrame: Baseline; Post cTBS (4 weeks after baseline
Secondary outcomes:
measure: Change in scores, reaction time and brain blood flow on the Working Memory Task by fNIRS
timeFrame: Baseline; Post cTBS (4 weeks after baseline)
measure: Change in size and connections of different parts of the brain to assess brain structure and blood flow by functional magnetic resonance imaging (fMRI)
timeFrame: Baseline; Post cTBS (4 weeks after baseline)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fei Li
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Fei Li, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: