Comparing the effectiveness of transcranial direct current stimulation treatment with common pharmacological treatments in autistic children’s symptoms

Comparing the effectiveness of transcranial direct current stimulation treatment with common pharmacological treatments on autistic children

A randomized, controlled, clinical trial with a parallel group design of 45 patients assigned into three groups (transcranial electrical stimulation intervention, pharmacological intervention, and sham intervention).

45 children with autism spectrum disorder are examined in Ardabil Fatemi Hospital as an intervention with tDCS stimulation, risperidone and placebo group and will be conducted in a double-blind design. The experimenter and the patient are blinded and are not aware of study. the experimenters who apply interventions are not aware of study hypotheses and the measurements will be carried out by independent experimenters who are blind to group assignment.

Inclusion: Diagnosis of autism spectrum disorder by a psychiatrist, being 6-16 years old required written iformed consent signed by parents, Exclusion: comorbidity with other neurodevelopmental disorders and neurological diseases

Intervention group 1: TDCS intervention protocol consists of 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days. Anodal electrode will be placed over the F3 and cathodal electrode will be placed over the Fp2. They will also receive placebo tablet ( Galenus pharmaceutical company). Intervention group 2: Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days. sham stimulation Group: Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablet ( Galenus pharmaceutical company) for 10 consecutive days. (according to the protocol of the previous two groups.)

Clinical symptoms, executive functions

The randomization method will be “simple randomization” (Suresh, 2011). This method randomization will be based on a single sequence of random assignments and include complete randomness of the assignment of patients to intervention groups (active tDCS group, pharmacology group, control group). Randomization will be done using an online website dedicated to randomizing sample size (https://www.randomizer.org/). By specifying the number of groups (n=3), the number of participants per group (n = 15), and the range of sample (1-45), participants will be randomly assigned to each group. Participants' code (1-45) will be randomly determined using draw. 45 children aged 6 to 16 with autism spectrum disorder that will be referred to the psychiatric clinic of Fatemi Hospital in Ardabil will receive one code upon referral using draw. Also, to prevent selective bias, the randomization method (for participants assignment) will be used and furthermore, concealment of random allocation will be applied.

The present study has a single-blind design. The care providers and outcome assessors are not aware of any type of pharmacological intervention or the state of electrical stimulation in patients. The investigators who determine intervention groups are independent from those experimenters who apply interventions and those who do the measurements and this will guarantee experimenters blindness for the electrical stimulation group (Gandinga et al., 2006) . For the patients, except those who are dedicated to pharmacological intervention, others in the electrical stimulation groups and control group are blind to the intervention. Patients in the real stimulation group, will not be aware of the stimulation condition (i.e., anodal stimulation vs sham stimulation). In patients assigned to control group, electrical stimulation includes 60 seconds of ramping up and down which induce sensations like the real stimulation, and participants are not expected to realize sham stimulation (Gandinga et al., 2006). These patients will be blind to the type of prescription drug as well as Risperidone and placebo are prepared entirely in one form (in terms of color, odor, and appearance).

Due to the confidentiality of the participants' personal characteristics

All collected data for the primary outcome measures only after anonymizing.

starting 12 months after publication

Researchers working in academic and scientific institutions

To raise the level of knowledge about the treatment of autistic children

Raw data and documents generated for this study are available from the corresponding authors and institution on reasonable request.

A formal request from person/institutions should be sent the corresponding authors and corresponding institution via email (for international users) and mail (for national users).