Efficacy of the Apollo System for Children With ADHD

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

Detailed Description
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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.

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

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Device: 8 weeks of home based use.


Participation Criteria
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Eligibility Criteria
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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: 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. Exclusion Criteria: The following exclusion criteria exist for all participants: 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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Commercial Apollo System Device<br>The active experimental group received the commercial Apollo System device. | Device: 8 weeks of home based use.<br>* Use of the devices for an 8 week study period. Devices are preset to follow a scheduled activation pattern during the day.<br>|
| Sham Comparator: Sham Apollo System Device<br>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.<br>* Use of the devices for an 8 week study period. Devices are preset to follow a scheduled activation pattern during the day.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Inhibition, Vibrational therapy