RecruitingNot ApplicableNCT06645587

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

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


Sponsor

Bambino Gesù Hospital and Research Institute

Enrollment

78 participants

Start Date

Oct 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 13 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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

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Interventions

DEVICEActive 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).

DEVICEActive 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).

DEVICESham 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.


Locations(1)

Bambino Gesù Children Hospital

Rome, Italy, Italy

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NCT06645587


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