Using Apollo Neuro in Autistic Children With Self-Injurious Behavior

This study will evaluate the feasibility and acceptability of the Apollo Neuro, a wearable vibrotactile sensory device, in autistic children who engage in self-injurious behavior (SIB). Participants will wear the device for at least 3 hours per day over a 30-35 day period with caregiver support. Outcomes will include adherence to device use, caregiver-reported feasibility and acceptability, and descriptive characterization of caregiver-reported self- injurious and repetitive behaviors during the study period. This preliminary, single-group study is not designed to evaluate efficacy and will inform the design of future controlled trials.

Inclusion Criteria for child: * Diagnosis of autism spectrum disorder (ASD), as reported by caregiver * Presence of self-injurious behavior, as reported by caregiver * Demonstrates sensory over and/or under- responsivity * Aged 6 years to 14 years, 11 months (179 months) at the time of enrollment * Has a caregiver willing and able to provide consent and participate in study procedures Exclusion Criteria for child: * Has medical condition that may increase risk with use of a wearable nibrotactile device, including: * implanted medical or neurological devices (e.g., pacemaker) * significant cardiac conditions or arrhythmias * history of syncope (fainting) * Known seizure disorder without physician clearance * Regular use of nibrotactile or autonomic- modulating wearable devices within the past 90 days * Any condition that, in the judgment of the investigator, would interfere with safe participation or interpretation of study procedures Inclusion Criteria for Caregiver: * Parent or legal guardian of the enrolled child participant * Able to provide informed consent in English * Able and willing to support device use according to study protocol and complete study-related data collection * Has access to a smartphone or compatible device capable of operating the Apollo Neuro application for the duration of study period Exclusion Criteria for Caregiver: • Unable to provide informed consent in English