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NCT Number: NCT07648420

Using Apollo Neuro 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.

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Key information

Conditions

Self-Injurious Behavior Autism Spectrum Disorder Behavior Behavioral Symptoms Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year–179 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth Uniersity

Richmond, Virginia, 23298, United States

Location contact

Laura Robins

CONTACT

[email protected]

757-541-8460

Stacey Reynolds

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Adherence to wearing the Apollo Neuro Wearable

    Time frame: 30-35 days

    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.

  2. Acceptability of Intervention Measure (AIM)

    Time frame: 30-35 days

    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.

  3. Feasibility of Intervention Measure (FIM)

    Time frame: 30-35 days

    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.

  4. The Repetitive Behavior Scale-Revised (RBS-R)

    Time frame: 30-35 days

    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.

  5. Change in intensity of self-injurious behavior

    Time frame: 30-35 days

    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.

  6. Changes in caregiver-reported SIB intensity

    Time frame: 30-35 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Lee Robins

CONTACT

[email protected]

(757) 285-3486

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

Feasibility and Usability of the Apollo Neuro, a Wearable Sensory Device, in Autistic Children With Self-Injurious Behavior

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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