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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-13
SponsorBambino Gesù Hospital and Research Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

  • 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.

Treatment groups

78 Participants
are divided into 3 treatment groups
Group A: Arm Pre-SMAActive comparator 1 intervention
Group B: Arm left-dlPFCActive comparator 1 intervention
Group C: Arm ShamSham comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Wisconsin Card Sorting Test

The version of the Wisconsin Card Sorting Test for developmental stages evaluates executive functions. The Modified Card Sorting Test (MCST; Nelson, 1976) assesses executive functions in children aged 4-13 years. It requires assigning 48 cards, on which one to four symbols are printed in different colors and shapes. The sorting rule (number, shape, color) changes after six correct assignments. The participant must deduce the current rule from the own pattern of responses. The number of right and wrong assignments and the number of errors will be computed.

Time frame
Baseline, pre-intervention; immediately after the intervention; three-month follow-up.
2

Stop Signal Task

The Stop Signal Task is a computerized task evaluating inhibitory control. The task is structured in line with the consensus guide of SST (Verbruggen et al., 2019) and it will be performed on PsychoPy® software (Open Science Tools Ltd., Nottingham, UK). The task duration will be approximately 14 minutes. The Stop Signal Task will yield the following measures: stop signal reaction time, calculated in milliseconds by subtracting a mean Stop Signal Delays from the observed mean reaction times in no-stop trials; go accuracy; go reaction times; Stop Signal Delay.

Time frame
Baseline, pre-intervention; immediately after the intervention; three-month follow-up.
3

Short Sensory Profile 2

The Short Sensory Profile 2 (Dunn, 2014) is a parent report questionnaire for evaluating the sensory processing pattern in children aged 3-14 years. It contains 34 items. Scores are assigned on a five-point Likert scale and range from "always = 0" to "often = 1" to "sometimes = 2" to "rarely = 3" to "never = 4". Low scores are indicative of frequent dysfunctional behavior. Based on a bell curve normed distribution, the raw score total for each quadrant can be classified as "much less than others" (lower 2%), "less than others" (between 1 SD and 2 SD below the mean, accounting for 14% of the normative sample), "just like the majority of others" (± 1 SD from the mean and accounting for 68% of the normative sample), "more than others" (between 1 SD and 2 SD above the mean), and "much more than others" (upper 2%).

Time frame
Baseline, pre-intervention; immediately after the intervention; three-month follow-up.
4

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

The Behavior Rating Inventory of Executive Function (Gioia et al., 2015) is a parent report questionnaire consisting of 63 items for an ecological and comprehensive evaluation of executive functions in children aged 5-18 years. The tool encompasses 63 items evaluating inhibition, self-monitoring, shift, initiation, working memory, emotional control, planning, task-monitoring, and organization of materials. Items are further dived into 4 indices as follows: the Behavior Regulation Index, the Emotion Regulation Index, the Cognitive Regulation Index, and the Global Executive Composite. Raw scores of each scale and index are converted into T scores (M = 50, SD = 10) and percentiles. For all clinical scales and indices, T scores from 60 to 64 and from 65 to 69 are considered respectively mildly elevated and potentially clinically elevated while T scores at or above 70 are clinically significant.

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

Other outcomes

Sponsors and contacts

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Bambino Gesù Hospital and Research Institute

Lead sponsor

Ministero della Salute, Italy

Collaborator