Efficacy of the Apollo System for Children With ADHD

Double-blind Randomized Placebo-controlled Trial of the Efficacy of the Apollo System for Children With ADHD

To determine the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.

Study Overview

• Status: Active, not recruiting
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Device: 8 weeks of home based use.

Detailed Description

The objective of this project is to understand the potential therapeutic benefits of the Apollo System for children with ADHD. Using vibrational therapy, the Apollo System has been previously demonstrated to promote greater balance of the autonomic nervous system. Given the importance of the autonomic nervous system for modulating levels of physiological arousal and in-turn governing aspects of attention and self-regulation; a therapeutic approach to promote better balance of this system may be particularly beneficial for populations such as children with ADHD. Accordingly, using a double-blind randomized placebo-controlled design this investigation will assess the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Department of Kinesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: All individuals that agreed to participate will be selected on a first come, first serve basis. No individual will be turned down due to sex, race, or ethnicity. The following inclusion criteria exist for all participants:

1. Participants must be 8 years of age or older and under the age of 18.
2. Participants must have diagnosed or suspected Attention Deficit Hyperactivity Disorder (ADHD).
3. Participants must have one of the following: 1) on the same treatment plan for over a year with minimal symptom relieve or alleviation, 2) tried two or more treatment approaches but is unable to meet treatment goals, 3) taking medication but still has symptoms, or 4) unwanted or uncontrollable side effects related to the medication.
4. Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.

Exclusion Criteria: The following exclusion criteria exist for all participants:

1. Lack of consent.
2. Participants cannot have started a new treatment within the last 30 days.
3. Participants cannot have a history of hydrocephalus, Autism Spectrum Disorder, Schizophrenia, Conduct disorder, Oppositional Defiant Disorder, active substance abuse, or be on a beta blocker.
4. Participants cannot have previously used the Apollo System.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Commercial Apollo System Device; The active experimental group received the commercial Apollo System device.	Device: 8 weeks of home based use.; Use of the devices for an 8 week study period. Devices are preset to follow a scheduled activation pattern during the day.
Sham Comparator: Sham Apollo System Device; The control experimental group received a sham/placebo device that is identical to the commercial Apollo System device but uses an ultra-low (i.e., effectively zero) frequency pattern of vibrations.	Device: 8 weeks of home based use.; Use of the devices for an 8 week study period. Devices are preset to follow a scheduled activation pattern during the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ADHD symptomatology as assessed using the ADHD-5 Rating Scale	At pre and posttest, the parents/guardians of participants will complete the ADHD-5 Rating Scale. The behaviors included in the survey are derived from the diagnostic criteria for ADHD established in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition. Scores are summated into inattentive and hyperactive-impulsive symptom domains and transformed into symptom percentile scores based upon normative data based on age and biological sex. Change in the overall ADHD percentile will be considered as the primary outcome. A more negative change would indicate a better outcome reflective of reduction in ADHD related symptomatology.	Prior to and following the 8 week study protocol period.
Effect Size for Change in Behavioral Index of Interference Control	At pre and posttest, participants will complete a version of the Eriksen flanker task. Response accuracy will be quantified within each congruency as the proportion of correct responses relative to the number of trials administered. The effect size of the change from pre-to-posttest in overall response accuracy will be considered as the primary outcome. Effect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013).	Prior to and following the 8 week study protocol period.
Effect Size for Change in Behavioral Index of Response Inhibition	At pre and posttest, participants will complete a version of the go/nogo task. Response accuracy will be quantified as the proportion of correct responses relative to the number of trials administered for target stimulus trails and nogo stimulus trials separately. The effect size of the change from pre-to-posttest for response accuracy to the nogo condition will be considered as the primary outcome. Effect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013).	Prior to and following the 8 week study protocol period.

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: The Board of Medicine
• Investigators: Principal Investigator: Matthew B Pontifex, PhD., Michigan State University

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2027

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ADHD; Inhibition; Vibrational therapy
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Behavior; Attention Deficit Disorder with Hyperactivity; Inhibition, Psychological
• Other Study ID Numbers: STUDY00005951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.
• IPD Sharing Time Frame: Data will be available following primary publication of the results.
• IPD Sharing Access Criteria: By request and completion of an institutional data-safety and sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

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