NCT03621189

The Impacts of Theta-burst Stimulation on Children and Adolescents With Autism Spectrum Disorder

Completed NA Results posted Last updated 23 January 2024

What this trial tests

NA trial testing intermittent theta burst stimulation in Autism Spectrum Disorder in 80 participants. Completed in 17 April 2019.

Timeline

2 November 2016

Primary endpoint
17 April 2019

17 April 2019

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	2 November 2016
Primary completion	17 April 2019
Estimated completion	17 April 2019
Sites	1 location across Taiwan

Drugs / interventions tested

• intermittent theta burst stimulation

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 7 to 18, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes of Total Scores of Social Responsiveness Scale Primary · baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)

Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260. The lower scores stand for better social responsiveness.

Baseline

Group	Value	95% CI
Active-Active	107.3	± 24
Sham-Active	102.1	± 23.2

During TBS

Group	Value	95% CI
Active-Active	103.4	± 25.5
Sham-Active	100.1	± 27.1

Post TBS

Group	Value	95% CI
Active-Active	98.5	± 28.7
Sham-Active	95.1	± 25.7

One month follow up

Group	Value	95% CI
Active-Active	97.2	± 25.6
Sham-Active	94.7	± 27.9

Changes of Total Scores of Repetitive Behavior Scale-Revised Primary · baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)

RBS-R is a questionnaire that focuses on repetitive behavior. The score range from 0-129. The lower scores stand for lower repetitive behavior.

Baseline

Group	Value	95% CI
Active-Active	32.2	± 18.9
Sham-Active	33.5	± 20.6

During TBS

Group	Value	95% CI
Active-Active	28.9	± 20.1
Sham-Active	28.1	± 21.5

Post TBS

Group	Value	95% CI
Active-Active	25.9	± 20.5
Sham-Active	31.5	± 23.9

One month follow up

Group	Value	95% CI
Active-Active	24.3	± 17.6
Sham-Active	29	± 23.9

Changes in Accuracy of Frith-Happe Animation Secondary · baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)

A quick and objective test of Theory of Mind. 8 questions in total, the more correct questions stand for better Social Cognition (The score ranges from 0-48).

Baseline

Group	Value	95% CI
Active-Active	5.5	± 2.1
Sham-Active	5.6	± 1.9

During TBS

Group	Value	95% CI
Active-Active	5.4	± 1.8
Sham-Active	5.7	± 2.2

Post TBS

Group	Value	95% CI
Active-Active	5.4	± 2
Sham-Active	5.4	± 2.3

One month follow up

Group	Value	95% CI
Active-Active	5.4	± 2.1
Sham-Active	5.2	± 2.6

Changes in Accuracy of Eyes Task Secondary · baseline; during TBS (4 weeks after baseline); post TBS (8 weeks after baseline); One month follow up (4 weeks after post TBS)

An advanced test for Theory of Mind. 43 questions in total, the more correct questions stand for better social skills (The score ranges from 0-43).

Baseline

Group	Value	95% CI
Active-Active	20.8	± 8
Sham Control	24.8	± 6.9

During TBS

Group	Value	95% CI
Active-Active	21.9	± 8.1
Sham Control	25.8	± 7

Post TBS

Group	Value	95% CI
Active-Active	21.8	± 9
Sham Control	24.8	± 6.3

One month follow up

Group	Value	95% CI
Active-Active	22	± 8.6
Sham Control	26	± 7.1

Adverse events — posted to ClinicalTrials.gov

Time frame: The adverse event would be assessed before and after intervention every session, up to 4 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active-Active

Serious: 0/40 (0%)

Deaths: 0/40

Sham-Active

Serious: 0/35 (0%)

Deaths: 0/35

Other adverse events (2 terms — click to expand)

Reaction	System	Active-Active	Sham-Active
Pain at application site	Nervous system disorders	—	—
Pain at application site	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT03621189 adverse events section.

Sponsor's own description

The investigator would like to investigate the impact of theta-burst stimulation over posterior superior temporal sulcus in children and adolescents with autism spectrum disorder

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Lack of effects of four-week theta burst stimulation on white matter macro/microstructure in children and adolescents with autism.
   Ni HC, Chao YP, Tseng RY, Wu CT, et al · · 2023 · cited 8× · PMID 36638598 · DOI 10.1016/j.nicl.2023.103324