What is the mechanism of action of this treatment?

The most common treatments for ADHD are stimulant medications such as methylphenidate and amphetamines, which work by increasing the levels of dopamine and norepinephrine in the brain, thereby enhancing attention and reducing hyperactive and impulsive behaviors. Non-stimulant medications like atomoxetine increase norepinephrine levels by inhibiting its reuptake. These mechanisms are crucial for ADHD patients as they help to normalize brain activity associated with attention and behavior control. The Apollo System, a wearable device delivering gentle vibrations to influence the autonomic nervous system, represents a novel approach by potentially modulating stress and improving focus through non-pharmacological means.

What side effects are associated with this type of intervention?

Common treatments for ADHD include stimulant medications like methylphenidate and amphetamines, as well as non-stimulant medications such as atomoxetine and guanfacine. Stimulant medications can cause side effects such as decreased appetite, insomnia, nausea, and, in some cases, new or worsening tics. Non-stimulant medications may also lead to side effects like decreased appetite, fatigue, and gastrointestinal issues. For treatments similar to the Apollo System, which aims to influence the autonomic nervous system, side effects are less well-documented but may include mild discomfort or skin irritation from the wearable device.

What prior FDA approvals exist?

The FDA has approved several treatments for ADHD, including medications like methylphenidate, atomoxetine, and guanfacine. Methylphenidate is available in various forms, including a transdermal system, which has shown efficacy in pediatric patients. Atomoxetine, a selective norepinephrine reuptake inhibitor, and guanfacine, an alpha-2 adrenergic agonist, are also approved for ADHD treatment. While the Apollo System, a wearable device delivering gentle vibrations, is being studied, similar non-pharmacological treatments like XR-assisted therapies are still in their infancy and have not yet received FDA approval.

What other types of research exist?

Promising alternatives to the Apollo System for ADHD treatment include: 1) Cognitive Behavioral Therapy (CBT), which has shown efficacy in managing ADHD symptoms. 2) Non-invasive neuromodulation techniques, such as transcranial magnetic stimulation (TMS), which are being explored for their potential benefits in ADHD. 3) Pharmacological advancements, including new formulations of existing medications like extended-release stimulants and non-stimulant medications. 4) Digital therapeutics, such as video game-based therapies designed to improve attention and cognitive function in children with ADHD.

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Not Applicable

Apollo System for ADHD

N/A

Waitlist Available

Led By Matthew B Pontifex, PhD.

Research Sponsored by Michigan State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to and following the 8 week study protocol period.

Summary

This trial is testing the Apollo System, a device that uses vibrations to help balance the body's nervous system. It is aimed at children with ADHD to see if it can help them focus and control their behavior better. The study will compare the effects of the device.

Who is the study for?

This trial is for children aged 8-18 with ADHD who have had minimal relief from current treatments, tried multiple treatments without meeting goals, still experience symptoms on medication, or suffer from medication side effects. It's open to all genders and ethnicities.

What is being tested?

The Apollo System is being tested over an 8-week period at home to see if it can reduce ADHD symptoms in children who meet the study criteria.

What are the potential side effects?

The information provided does not specify side effects of the Apollo System. Typically, clinical trials monitor participants for any adverse reactions during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 8 and 17 years old.

Select...

I have been diagnosed with or suspected to have ADHD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to and following the 8 week study protocol period.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to and following the 8 week study protocol period.

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to and following the 8 week study protocol period. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in ADHD symptomatology as assessed using the ADHD-5 Rating Scale

Effect Size for Change in Behavioral Index of Interference Control

Effect Size for Change in Behavioral Index of Response Inhibition

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Commercial Apollo System DeviceExperimental Treatment1 Intervention

The active experimental group received the commercial Apollo System device.

Group II: Sham Apollo System DevicePlacebo Group1 Intervention

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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ADHD are stimulant medications such as methylphenidate and amphetamines, which work by increasing the levels of dopamine and norepinephrine in the brain, thereby enhancing attention and reducing hyperactive and impulsive behaviors. Non-stimulant medications like atomoxetine increase norepinephrine levels by inhibiting its reuptake. These mechanisms are crucial for ADHD patients as they help to normalize brain activity associated with attention and behavior control. The Apollo System, a wearable device delivering gentle vibrations to influence the autonomic nervous system, represents a novel approach by potentially modulating stress and improving focus through non-pharmacological means.

Enhancing attention in neurodegenerative diseases: current therapies and future directions.Attention-deficit/hyperactivity disorder and complementary/alternative medicine.