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Effect of rTMS on the Abnormal Executive Function of ASD Children

NCT04237870 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-01-23

No results posted yet for this 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 Based on results from a recent unpublished pilot data, the investigators propose that cTBS treatment will induce a significant improvement in executive function performance compared to sham treatment.

Conditions

  • Executive Dysfunction
  • ASD

Interventions

DEVICE

Active cTBS

Active cTBS treatment will be delivered at an intensity that is 70% of the resting motor threshold (RMT). cTBS consist of bursts of 3 magnetic pulses at 30 Hz repeating every 200 ms for 300 pulses. cTBS will be repeated twice with 15 min interval. The cTBS sessions last for 4 weeks, 5 times a week. Treatment will be applied to central suleus.

DEVICE

Sham

Sham stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but with only the side-edge resting on the scalp. The coil will be angled 45 degrees way from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g. contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Fei Li, PhD, MD · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-08-31
Completion
2021-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04237870 on ClinicalTrials.gov