Using Apollo Neuro in Autistic Children With Self-Injurious Behavior

NCT07648420 | Not Yet Recruiting FDA Device

• 1 other identifier: HM300001048
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Self-Injurious Behavior; Autism Spectrum Disorder

Keywords

Apollo Neuro Device; Sensory Responsivity; Autonomic Regulation; Wearable Device; Vibrotactile Stimulation

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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. WHAT IS A GOOD SCORE? NEED A DESCRIPTION.

  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

Study Arms (1)

Apollo Neuro device

EXPERIMENTAL

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

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.

Apollo Neuro device

Eligibility Criteria

• Age: 6 Years - 179 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Unable to provide informed consent in English

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth Uniersity

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Self-Injurious Behavior; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Stacey Reynolds

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Lee Robins

CONTACT

(757) 285-3486; robinslp@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility, Quasi-experimental, within subject, pre- and post-test design

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)