Clinical trial NCT06645587: Targeting Repetitive Behaviors in Autism Spectrum Disorder Via Transcranial Direct Current Stimulation
Official title: Understanding and Targeting Repetitive Behaviors and Restricted Interests in Autism Spectrum Disorder Via High-Definition Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
HD-tDCS
Restricted Interests
Repetitive Behaviors
Neurodevelopmental Disorders
transcranial direct current stimulation
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Ministero della Salute, Italy
First posted: 2024-10-17
Enrollment: 78
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Repetitive Behavior Scale-Revised
timeFrame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.
Secondary outcomes:
measure: Wisconsin Card Sorting Test
timeFrame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.
measure: Stop Signal Task
timeFrame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.
measure: Short Sensory Profile 2
timeFrame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.
measure: Behavior Rating Inventory of Executive Function - Second Edition/ parent report
timeFrame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.
measure: Sleep Disturbance Scale for Children
timeFrame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.
measure: Child Behaviour Checklis/ 6-18
timeFrame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.
measure: Childhood Autism Rating Scale-2
timeFrame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.
measure: Parenting Stress Index Short Form
timeFrame: Baseline, pre-intervention; immediately after the intervention; three-month follow-up.
measure: Electroencephalography (HD-EEG)
timeFrame: Baseline, pre-intervention and immediately after the intervention.
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bambino Gesù Children Hospital
Study officials:
References: