Using Apollo Neuro in Autistic Children With Self-Injurious Behavior

Feasibility and Usability of the Apollo Neuro, a Wearable Sensory Device, 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Self-Injurious Behavior; Autism Spectrum Disorder
• Intervention / Treatment: Device: Apollo Neuro device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Lee Robins; Phone Number: (757) 285-3486; Email: robinslp@vcu.edu

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth Uniersity
      • Contact: Laura Robins; Phone Number: 757-541-8460; Email: robinslp@vcu.edu
      • Principal Investigator: Stacey Reynolds

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to wearing the Apollo Neuro Wearable	Caregiver-reported acceptability of the intervention, as measured by the Acceptability of Intervention Measure (AIM), a validated 4-item instrument assessing the perceived agreeableness, satisfaction, and usability of the intervention. Each item is rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). Responses will be summarized descriptively using mean scores and response distributions.	30-35 days
Acceptability of Intervention Measure (AIM)	Caregiver-reported acceptability of the intervention, as measured by the Acceptability of Intervention Measure (AIM), a validated 4-item instrument assessing the perceived agreeableness, satisfaction, and usability of the intervention. Each item is rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). Responses will be summarized descriptively using mean scores and response distributions.	30-35 days
The Repetitive Behavior Scale-Revised (RBS-R)	Caregiver-reported behaviors, as measured by the Repetitive Behavior Scale-Revised (RBS-R), a validated 43-item questionnaire assessing the presence and severity of restricted and repetitive behaviors in individuals with autism spectrum disorder, including self-injurious behavior. The measure is completed by caregivers at baseline and post-intervention using a 4-point Likert scale. Scores will be summarized descriptively to characterize patterns over the study period.	30-35 days
Changes in caregiver-reported SIB intensity	Daily caregiver-reported ratings of peak self-injurious behavior intensity, measured using a visual analog scale (VAS) recorded on a study-designed data collection form. Caregivers will provide ratings each day throughout the intervention period. Data will be summarized descriptively to characterize variability and patterns over time.	30-35 days
Feasibility of Intervention Measure (FIM)	Caregiver-reported feasibility of the intervention, as measured by the Feasibility of Intervention Measure (FIM), a validated 4-item instrument assessing the extent to which the intervention can be successfully implemented within the home setting. Each item is rated on a 5-point Likert scale ranging from 1(Completely disagree) to 5 (Completely agree). Responses will be summarized descriptively using mean scores and response distributions.	30-35 days
Change in intensity of self-injurious behavior	Changes in the intensity of self-injurious behavior associated with the use of the Apollo Neuro wearable device will be measured by caregiver-reported tracking daily ratings of peak self-injurious behavior intensity on a study designed form tracking the participant adherence.	30-35 days

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Stacey Reynolds, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Wearable Device; Autonomic Regulation; Apollo Neuro Device; Sensory Responsivity; Vibrotactile Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Behavior; Autism Spectrum Disorder; Self-Injurious Behavior
• Other Study ID Numbers: HM300001048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes