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Using Apollo Neuro in Autistic Children With Self-Injurious Behavior

NCT07648420 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-08-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Apollo Neuro 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.

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Stacey Reynolds · Virginia Commonwealth University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
179 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2027-11-30
Completion
2027-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07648420 on ClinicalTrials.gov