tPCS for Autism
Trial question
What is the effect of prefrontal-cerebellar transcranial pulsed current stimulation in children with autism spectrum disorder?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 312
312 patients (64 female, 248 male).
Inclusion criteria: children, aged 3-14 years, with autism spectrum disorder.
Key exclusion criteria: epilepsy; craniotomy; implanted devices; severe psychiatric conditions; active scalp infection; obstructive sleep apnea; active use of benzodiazepine, risperidone, or haloperidol; prior noninvasive brain stimulation.
Interventions
N=155 transcranial pulsed current stimulation (20 sessions of transcranial pulsed current stimulation over 4 weeks, 20 min/day, electrodes over right cerebellar and left prefrontal cortex).
N=157 sham stimulation (20 sessions of sham stimulation over 4 weeks, 20 min/day, electrodes over right cerebellar and left prefrontal cortex).
Primary outcome
Mean reduction in Autism Treatment Evaluation Checklist total score
7.17 points
4.13 points
7.2 points
5.4 points
3.6 points
1.8 points
0.0 points
Transcranial pulsed current
stimulation
Sham
stimulation
Significant
increase ▲
Significantly greater reduction in mean Autism Treatment Evaluation Checklist total score (7.17 points vs. 4.13 points; MD 3.5, 95% CI 1.43 to 5.56).
Secondary outcomes
Significantly greater reduction in mean Autism Behavior Checklist total score (6 points vs. 1.6 points; MD 4, 95% CI 2.26 to 5.75).
Significantly greater reduction in mean Childhood Sleep Habits Questionnaire total score (4.2 points vs. 1.9 points; MD 2.19, 95% CI 1.19 to 3.2).
Safety outcomes
No significant difference in adverse events.
Conclusion
In children, aged 3-14 years, with autism spectrum disorder, transcranial pulsed current stimulation was superior to sham stimulation with respect to mean reduction in Autism Treatment Evaluation Checklist total score.
Reference
Zhenhuan Liu, Sandra Zhong, Roger C M Ho et al. Transcranial Pulsed Current Stimulation and Social Functioning in Children With Autism: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e255776.
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