Self-Injurious BehaviorNCT07648420
Using Apollo Neuro in Autistic Children With Self-Injurious Behavior
A study testing Apollo Neuro device in people with Self-Injurious Behavior and Autism Spectrum Disorder, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years to 179 months
- Conditions the study is for
- Self-Injurious Behavior, Autism Spectrum Disorder
- What is being tested?
- Apollo Neuro device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years to 179 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Parent or legal guardian of the enrolled child participant
Show all 9Show fewer
- 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
Who cannot join
- 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
- Unable to provide informed consent in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Virginia Commonwealth Uniersity
Richmond, Virginia, 23298
Laura Robins, 757-541-8460, robinslp@vcu.edu
Stacey Reynolds
About this study
Official title: 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.
Read the 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.
- Conditions
- Self-Injurious Behavior, Autism Spectrum Disorder
- Being tested
- Apollo Neuro device
- Keywords
- Apollo Neuro Device, Sensory Responsivity, Autonomic Regulation, Wearable Device, Vibrotactile Stimulation
- Medical subject headings
- Self-Injurious Behavior, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo Neuro deviceDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Apollo Neuro device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30-35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-Injurious BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility, Quasi-experimental, within subject, pre- and post-test design
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacey Reynolds, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648420
- Sponsor's protocol ID
- HM300001048
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Usability of the Apollo Neuro, a Wearable Sensory Device, in Autistic Children With Self-Injurious Behavior
- ClinicalTrials.gov ID
- NCT07648420
- Acronym / sponsor ID
- HM300001048
- Conditions
- Self-Injurious Behavior, Autism Spectrum Disorder
- Keywords
- Apollo Neuro Device, Sensory Responsivity, Autonomic Regulation, Wearable Device, Vibrotactile Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility, Quasi-experimental, within subject, pre- and post-test design
| Arm | Type | Receives |
|---|---|---|
| Apollo Neuro device | Experimental | Device: Apollo Neuro deviceWearing 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. |
Who may qualify
- Ages
- 6 years to 179 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- Has medical condition that may increase risk with use of a wearable nibrotactile device, including:
- 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
- Unable to provide informed consent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apollo Neuro deviceChild 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. | Device | Apollo Neuro device |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stacey Reynolds principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apollo Neuro device in people with Self-Injurious Behavior and Autism Spectrum Disorder, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Lee Robins ((757) 285-3486, robinslp@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to wearing the Apollo Neuro Wearable (time frame: 30-35 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.