Using brain stimulation to reduce repetitive behaviors in autism
Understanding and Targeting Repetitive Behaviors and Restricted Interests in Autism Spectrum Disorder Via High-Definition Transcranial Direct Current Stimulation
NA · Bambino Gesù Hospital and Research Institute · NCT06645587
This study is testing if a special type of brain stimulation can help reduce repetitive behaviors in children and teens with autism.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 8 Years to 13 Years |
| Sex | All |
| Sponsor | Bambino Gesù Hospital and Research Institute (other) |
| Locations | 1 site (Rome, Italy) |
| Trial ID | NCT06645587 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of high-definition transcranial direct current stimulation (HD-tDCS) in reducing repetitive behaviors in children and adolescents with Autism Spectrum Disorder (ASD). Participants will be randomly assigned to receive either active HD-tDCS targeting specific brain areas or a sham treatment. The study aims to differentiate the effects of stimulation on lower-order and higher-order repetitive behaviors and assess associated changes in psychological measures and brain activity. The findings could provide insights into new rehabilitation strategies for managing ASD symptoms.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 8 to 13 years with a diagnosis of Autism Spectrum Disorder and an IQ of 70 or higher.
Not a fit: Patients with neurological conditions, other primary psychiatric diagnoses, or those currently undergoing specific cognitive-behavioral therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce repetitive behaviors in children with autism, improving their quality of life.
How similar studies have performed: While the use of HD-tDCS is a novel approach in this context, similar studies have shown promise in targeting brain functions to alleviate symptoms in neurodevelopmental disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Rome, Italy
- Bambino Gesù Children Hospital — Rome, Italy, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorder, HD-tDCS, Restricted Interests, Repetitive Behaviors, Neurodevelopmental Disorders, transcranial direct current stimulation