Temporal Pole Transcranial Alternating Current Stimulation for Children With Autism Spectrum Disorder: A Randomized Controlled Open-Label Trial
Temporal Pole Transcranial Alternating Current Stimulation for Children With Autism Spectrum Disorder: A Randomized Controlled Open-Label Trial
The goal of this open-label randomized controlledl trial is to explore the safety and efficacy of conventional transcranial alternating current stimulation (tACS) and transcranial temporal interference stimulation (tTIS) targeting the temporal pole in children with autism spectrum disorder (ASD) in China. The main questions it aims to answer are:
*Can tACS and tTIS safely and effectively improve clinical symptoms in children with autism?
Researchers will compare the tACS group and tTIS group with control group to explore the safety, feasibility and efficacy of the transcranial electrical stimulation in children with autism.
Participants will:
From baseline to 4 weeks after intervention completion, subjects will be followed up regarding clinical symptoms and adverse reactions:
This research is a 5-week prospective, open-label, randomized controlled trial, planning to enroll 36 autistic children aged 4-10 with a full-scale intelligence quotient (FSIQ) of 50 or above. Children who satisfy all inclusion criteria without meeting any exclusion criteria, may be enrolled after their legal guardians provided the written informed consent.
Eligible subjects will be randomly divided into three groups: tACS group, tTIS group and control group. The tACS group will undergo 5 days of temporal pole tACS stimulation (1.5mA, 40Hz, 20min/session, 6 sessions/day); the tTIS group will undergo 5 days of temporal pole TI stimulation（1.5mA, 2040/2000Hz, 20min/session, 6 sessions/day）; the control group will receive routine rehabilitation training during the study period, including various rehabilitation services provided by the community.
At baseline, subjects will undergo physical measurements, demographic and medical history collection, intelligence test and symptom clinical scale assessments, and resting-state EEG collection. From the start of intervention until 4 weeks after completion, subjects will be followed up regarding clinical symptoms, neuroimaging, and adverse reactions.
The safety outcome: adverse events and their rate. The primary efficacy outcome is the change in Social Responsiveness Scale (SRS-2) scores 4 weeks after intervention completion compared to pre-intervention.
Secondary outcomes include changes in SRS-2 scores immediately after the 5-day intervention compared to pre-intervention; and changes in Chinese Communicative Development Inventory (CCDI), Childhood Autism Rating Scale (CARS), Peabody Picture Vocabulary Test (PPVT), Developmental Neuropsychological Assessment (NEPSY-II, including narrative memory, facial memory, theory of mind, vocabulary generation) four items, and Clinical Global Impression (CGI) scale scores 4 weeks after the 5-day intervention compared to pre-intervention.
Exploratory indicators include changes in resting-state EEG neuroimaging characteristics before intervention, immediately after the 5-day intervention, and 4 weeks after the 5-day intervention.
Inclusion Criteria:
Exclusion Criteria: