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

NCT06645587 | Recruiting

• 1 other identifier: GR-2021-12375413
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; HD-tDCS; Restricted Interests; Repetitive Behaviors; Neurodevelopmental Disorders; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Repetitive Behavior Scale-Revised

  The primary outcome measure will be the Total Score of the Repetitive Behavior Scale-Revised (Bodfish, 2000). It consists of a 43-item parent-report questionnaire evaluating the extent of RBs in individuals with ASD. The tool encompasses six scales: Stereotyped Behavior (6 items), Self-injurious Behavior (8 items), Compulsive Behavior (8 items), Routine Behavior (6 items), Sameness Behavior (11 items), and Restricted Behavior (4 items). The items are rated on a four-point scale (0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem); an overall total raw score and a total number of items score for each subscale are computed. Higher scores indicate greater severity of repetitive behaviors. The sum of all items provides a total raw score ranging from 0 to 129, with higher scores indicating more severe repetitive behaviors.

  Baseline, pre-intervention; immediately after the intervention; three-month follow-up.

Secondary Outcomes (9)

• Wisconsin Card Sorting Test

  Baseline, pre-intervention; immediately after the intervention; three-month follow-up.

• Stop Signal Task

  Baseline, pre-intervention; immediately after the intervention; three-month follow-up.

• Short Sensory Profile 2

  Baseline, pre-intervention; immediately after the intervention; three-month follow-up.

• Behavior Rating Inventory of Executive Function - Second Edition/ parent report

  Baseline, pre-intervention; immediately after the intervention; three-month follow-up.

• Sleep Disturbance Scale for Children

  Baseline, pre-intervention; immediately after the intervention; three-month follow-up.

Study Arms (3)

Arm Pre-SMA

ACTIVE COMPARATOR

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.

Device: Active HD-tDCS over pre-SMA

Arm left-dlPFC

ACTIVE COMPARATOR

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.

Device: Active HD-tDCS over left DLPFC

Arm Sham

SHAM COMPARATOR

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.

Device: Sham HD-tDCS

Interventions

Active HD-tDCS over pre-SMA DEVICE

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).

Arm Pre-SMA

Active HD-tDCS over left DLPFC DEVICE

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).

Arm left-dlPFC

Sham HD-tDCS DEVICE

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.

Arm Sham

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead
• Ministero della Salute, Italy: collaborator

Study Sites (1)

Bambino Gesù Children Hospital

Rome, Italy, 00152, Italy

RECRUITING

Related Publications (1)

• 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/s12888-025-06506-y.

  PMID: 40001028 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 17, 2024
• Study Start: October 3, 2024
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 17, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)