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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 13
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Bambino Gesù Children Hospital
RECRUITING
Rome
Time Frame
Start Date: 2024-10-03
Estimated Completion Date: 2026-04
Participants
Target number of participants: 78
Treatments
Active_comparator: Arm Pre-SMA
Active cathodal HD-tDCS over pre-SMA cortex. For HD-tDCS a 4 × 1 montage, small circular electrodes (diameter 1 cm) will be used with the cathode placed centrally over Fz with a current intensity of 0.5 mA for a total of 20 minutes (30 s ramp up/down).~For the electrodes' placement, the investigators will follow the recommended guidelines for children.
Active_comparator: Arm left-dlPFC
Active cathodal HD-tDCS over left dlPFC cortex. For HD-tDCS a 4 × 1 montage, small circular electrodes (diameter 1 cm) will be used with the cathode placed centrally over F3 with a current intensity of 0.5 mA for a total of 20 minutes (30 s ramp up/down).~For the electrodes' placement, the investigators will follow the recommended guidelines for children.
Sham_comparator: Arm Sham
Sham HD-tDCS will be delivered over pre-SMA or left-dlPFC cortex. 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.
Related Therapeutic Areas
Sponsors
Collaborators: Ministero della Salute, Italy
Leads: Bambino Gesù Hospital and Research Institute

This content was sourced from clinicaltrials.gov