NCT03814083

Transcranial Direct Current Stimulation in Autism Spectrum Disorder

Completed NA Last updated 15 November 2022

What this trial tests

NA trial testing Active-tDCS in Transcranial Direct Current Stimulation in 105 participants. Completed in 31 August 2022.

Timeline

23 July 2019

Primary endpoint
28 February 2022

31 August 2022

Quick facts

Lead sponsor	The Hong Kong Polytechnic University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	105
Start date	23 July 2019
Primary completion	28 February 2022
Estimated completion	31 August 2022
Sites	1 location across Hong Kong

Drugs / interventions tested

• Active-tDCS
• Sham-tDCS
• Wait-list

Conditions studied

• Transcranial Direct Current Stimulation — all drugs for Transcranial Direct Current Stimulation →
• Autistic Disorders Spectrum — all drugs for Autistic Disorders Spectrum →
• Electroencephalography — all drugs for Electroencephalography →

Sponsor

The Hong Kong Polytechnic University

Who can join

Adults 14 to 21, any sex, with Transcranial Direct Current Stimulation or Autistic Disorders Spectrum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Transcranial Direct Current Stimulation (tDCS) is a form of non-invasive brain stimulation that has aroused increased interests in the past decade. Not only that it is transient with little side-effects, and can be well-tolerated by children, it is also affordable and readily accessible, making it an appealing treatment option for autism spectrum disorder (ASD).

Objective: (1) To assess the therapeutic effects of tDCS when combined with cognitive training for 10 consecutive weekdays on improving cognitive processing in adolescents with ASD, relative to control group receiving sham-stimulation, and (2) to evaluate the associated neural mechanisms underlying the treatment effect of tDCS on adolescents with ASD.

Methods: 105 adolescents with ASD will be randomly assigned to active- (n=35), sham- (n=35) tDCS, or no-treatment control (n=35) groups. Twenty minute sessions of 1 mA cathodal stimulation to the left dorsolateral prefrontal cortex (DLPRC) in conjunction with cognitive training exercise will be provided on 10 consecutive weekdays. EEGs, functional near-infrared spectroscopy, and neuropsychological tests will be administered before, 1 day and 6 months after the series of tDCS sessions.

Hypothesis: We hypothesized that cathodal (inhibitory) tDCS over the left DLPRC will induce (1) stimulation-linked facilitation of learning and enhanced processing speed and resultant improvement of cognitive functioning, in executive function, relative to the sham-tDCS and the wait-list controls, (2) active-tDCS, but not sham-tDCS and wait-list controls, will modulate the intra- and inter-hemispheric neural connectivity, indexed by altered level EEG theta coherence and aberrant fNIRS haemodynamic measures, across brain areas implicated in executive functioning.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neurophysiological and behavioral effects of multisession prefrontal tDCS and concurrent cognitive remediation training in patients with autism spectrum disorder (ASD): A double-blind, randomized controlled fNIRS study.
   Han YMY, Chan MMY, Shea CKS, Lai OL, et al · · 2022 · cited 43× · PMID 35181532 · DOI 10.1016/j.brs.2022.02.004
2. Recent advancements in noninvasive brain modulation for individuals with autism spectrum disorder.
   Griff JR, Langlie J, Bencie NB, Cromar ZJ, et al · · 2023 · cited 13× · PMID 36453393 · DOI 10.4103/1673-5374.360163