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Recruiting NCT06645587

Targeting Repetitive Behaviors in Autism Spectrum Disorder Via Transcranial Direct Current Stimulation

No phase Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active HD-tDCS over pre-SMA, Active HD-tDCS over left DLPFC, Sham HD-tDCS.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 8 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Understanding and Targeting Repetitive Behaviors and Restricted Interests in Autism Spectrum Disorder Via High-Definition Transcranial Direct Current Stimulation

Overview

Repetitive behaviors (RBs) are a prevalent feature of Autism Spectrum Disorder (ASD). There are two groups of RBs: lower-order (e.g. motor stereotypies) and higher-order RBs (e.g. restricted interests), linked to sensory-motor and the associative loops, respectively. To date, treatment options for RBs are very limited. High-definition transcranial direct current stimulation (HD-tDCS) may be effective in reducing the impact of RBs in children with ASD by targeting the associated brain alterations. Moreover, the high focality of HD-tDCS will help the investigators to disentangle the relative contribution of different brain loops (namely, sensory-motor and the associative loops) into RBs subtypes. The investigators will also study the electrophysiological patterns associated to behavioral changes after the application of HD-tDCS.

Detailed description

The experimental design will be the following: randomized, three-arm, between subject, double blind, and placebo-controlled.

Children and adolescents with ASD will be selected and randomly assigned to three groups: 1. Active high-definition tDCS (HD-tDCS) over pre-SMA; 2. Active high-definition tDCS (HD-tDCS) left DLPFC; 3. Sham high-definition tDCS (HD-tDCS).

In this project, the investigators will work to understand whether a brain-based intervention, with the use of HD-tDCS can enhance RBs in individuals with ASD.

The protocol will allow the investigators to:

1. Test if Active high-definition tDCS (HD-tDCS) compared to sham HD-tDCS will contribute in reducing RBs 2. Test if HD-tDCS over pre-SMA cortex will decrease lower-order RBs, while HD-tDCS over dlPFC will decrease higher-order RBs 3. Test if the Active Groups will significantly improve in the remaining psychological measures compared to the Sham Group 4. Test if the Active Groups will change in the RBS-R total score will be significantly correlated with changes in neuropsychological and electroencephalographic (EEG) connectivity measures 5. Test if the Active Groups will change in the RBS-R total score will be significantly correlated with changes in the remaining psychological measures and parental stress.

The overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in ASD.

Interventions

  • Device Active HD-tDCS over pre-SMA
    Active cathodal HD-tDCS over pre-SMA cortex will be delivered for 10 days (3 sessions per week). The 4 × 1 montage using small circular electrodes (diameter 1 cm) will be applied with the cathode placed centrally over Fz. The current intensity will be set at 0.5 mA for a total of 20 minutes (30 s ramp up/down).
  • Device Active HD-tDCS over left DLPFC
    Active cathodal HD-tDCS over left DLPFC cortex will be delivered for 10 days (3 sessions per week). The 4 × 1 montage using small circular electrodes (diameter 1 cm) will be applied with the cathode placed centrally over F3. The current intensity will be set at 0.5 mA for a total of 20 minutes (30 s ramp up/down).
  • Device Sham HD-tDCS
    Sham HD-tDCS will be delivered over pre-SMA or left-dlPFC cortex for 10 days (3 sessions per week). The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down (0 mA) during the rest of the session without the participants awareness. Each Sham session will last 20 minutes.

Primary outcome measures

  • Repetitive Behavior Scale-Revised [Time frame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.]
Secondary outcome measures (9)
  • Wisconsin Card Sorting Test [Time frame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.]
  • Stop Signal Task [Time frame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.]
  • Short Sensory Profile 2 [Time frame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.]
  • Behavior Rating Inventory of Executive Function - Second Edition/ parent report [Time frame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.]
  • Sleep Disturbance Scale for Children [Time frame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.]
  • Child Behaviour Checklis/ 6-18 [Time frame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.]
  • Childhood Autism Rating Scale-2 [Time frame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.]
  • Parenting Stress Index Short Form [Time frame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.]
  • Electroencephalography (HD-EEG) [Time frame: Baseline, pre-intervention and immediately after the intervention.]

Eligibility criteria

Inclusion criteria

  • participants of both genders with ASD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and based on clinical evaluation and administration of gold standard tools for ASD diagnosis
  • an intelligence quotient (IQ) higher or equal to 70 (IQ ≥ 70)
  • age range from 8 years to 13 years and 11 months included

Exclusion criteria

  • the presence of neurological/medical/genetic conditions (i.e., brain tumours or genetic syndromes)
  • personal or family history of epilepsy
  • other primary psychiatric diagnoses (i.e., bipolar disorders, schizophrenia spectrum disorders, or adjustment disorder)
  • sensorimotor deficits
  • the presence of peacemaker or other metal devices in the body;
  • ongoing CNS-active drug treatment
  • receiving other cognitive-behavioral therapies specifically focused on RBs in the 3 months before the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Bambino Gesù Children Hospital — Rome

Publications

  • Lazzaro G, Passarini S, Battisti A, Costanzo F, Garone G, Mercier M, D'Aiello B, De Rossi P, Valeri G, Guerrera S, Casula L, Menghini D, Vicari S, Fuca E. Understanding and targeting repetitive behaviors and restricted interests in autism spectrum disorder via high-definition transcranial direct current stimulation: a study-protocol. BMC Psychiatry. 2025 Feb 25;25(1):170. doi: 10.1186/s12888-025-0 PMID 40001028

Identifiers

NCT: NCT06645587 · GR-2021-12375413

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗