Efficacy of the Apollo System for Children With ADHD

Not Applicable

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Device: 8 weeks of home based use.

• Registration Number: NCT05308706
• Lead Sponsor: Michigan State University

Brief Summary

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

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 Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-18
• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-03-24
• Last Update Submitted: 2022-03-24
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-04
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Apollo System Device	8 weeks of home based use.	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.
Commercial Apollo System Device	8 weeks of home based use.	The active experimental group received the commercial Apollo System device.

Primary Outcome Measures

Name	Time	Method
Effect Size for Change in Behavioral Index of Interference Control	Prior to and following the 8 week study protocol period.	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).
Change in ADHD symptomatology as assessed using the ADHD-5 Rating Scale	Prior to and following the 8 week study protocol period.	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.
Effect Size for Change in Behavioral Index of Response Inhibition	Prior to and following the 8 week study protocol period.	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).

Trial Locations

Locations (1)

Department of Kinesiology; 🇺🇸 East Lansing, Michigan, United States