Efficacy of the Apollo System for Children With ADHD

NCT05308706 | Active Not Recruiting FDA Device

• 1 other identifier: STUDY00005951
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; Inhibition; Vibrational therapy

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

Commercial Apollo System Device

EXPERIMENTAL

The active experimental group received the commercial Apollo System device.

Device: 8 weeks of home based use.

Sham Apollo System Device

SHAM COMPARATOR

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.

Interventions

8 weeks of home based use. DEVICE

Use of the devices for an 8 week study period. Devices are preset to follow a scheduled activation pattern during the day.

Commercial Apollo System Device; Sham Apollo System Device

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants must be 8 years of age or older and under the age of 18.
• Participants must have diagnosed or suspected Attention Deficit Hyperactivity Disorder (ADHD).
• 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.
• Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.

You may not qualify if:

• Lack of consent.
• Participants cannot have started a new treatment within the last 30 days.
• 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.
• Participants cannot have previously used the Apollo System.

Sponsors & Collaborators

• Michigan State University: lead
• The Board of Medicine: collaborator

Study Sites (1)

Department of Kinesiology

East Lansing, Michigan, 48824, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Inhibition, Psychological

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Matthew B Pontifex, PhD.

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind, sham/placebo controlled trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants receive an Apollo System device. However, participants are randomly assigned to receive a device that uses the current pattern of vibrations as in the commercial Apollo System device or receive a device that uses an ultra-low frequency pattern of vibrations (sham device).

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 4, 2022
• Study Start: March 18, 2022
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available following primary publication of the results.
• Access Criteria: By request and completion of an institutional data-safety and sharing agreement.

Locations

US (1)