Efficacy of the Apollo System for Children With ADHD

M

Michigan State University

Status

Enrolling

Conditions

Attention Deficit Disorder With Hyperactivity

Treatments

Device: 8 weeks of home based use.

Study type

Interventional

Funder types

Other

Identifiers

NCT05308706
STUDY00005951

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

8 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Commercial Apollo System Device
Experimental group
Description:
The active experimental group received the commercial Apollo System device.
Treatment:
Device: 8 weeks of home based use.
Sham Apollo System Device
Sham Comparator group
Description:
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.
Treatment:
Device: 8 weeks of home based use.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Matthew B Pontifex, PhD

Data sourced from clinicaltrials.gov

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