Using Apollo Neuro in Autistic Children With Self-Injurious Behavior

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT07648420
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 179 Months
Healthy Volunteers
Not accepted

Interventions

  • Apollo Neuro device — DEVICE
    Child participants will wear the activated device for a minimum of three hours per day on at least 30 of 35 consecutive days, consistent with the study protocol. The device is worn externally (e.g., wrist, ankle, or waist) and delivers low intensity vibrations through intact skin.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Apollo Neuro device
    Wearing of activated Apollo Neuro device for at least three hours/day for 30 of 35 consecutive days by Autistic children with SIB and sensory over and/or under responsivity.

Primary Outcome Measure

Adherence to wearing the Apollo Neuro Wearable [ Time Frame: 30-35 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniersityRichmondVirginia23298
Laura Robins
[email protected]
757-541-8460
Stacey Reynolds (PRINCIPAL_INVESTIGATOR)

Find similar trials in Richmond, VA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Virginia Commonwealth Uniersity· Richmond, VA

Related Studies