Using Apollo Neuro in Autistic Children With Self-Injurious Behavior
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-179
SponsorVirginia Commonwealth University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
implanted medical or neurological devices (e.g., pacemaker)
significant cardiac conditions or arrhythmias
history of syncope (fainting)
Known seizure disorder without physician clearance
Trial design
Treatments tested in this trial
- Apollo Neuro device
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov