Clinical trial NCT05308706: Efficacy of the Apollo System for Children With ADHD
Official title: Double-blind Randomized Placebo-controlled Trial of the Efficacy of the Apollo System for Children With ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Inhibition
Vibrational therapy
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: The Board of Medicine
First posted: 2022-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Change in ADHD symptomatology as assessed using the ADHD-5 Rating Scale
timeFrame: Prior to and following the 8 week study protocol period.
measure: Effect Size for Change in Behavioral Index of Interference Control
timeFrame: Prior to and following the 8 week study protocol period.
measure: Effect Size for Change in Behavioral Index of Response Inhibition
timeFrame: Prior to and following the 8 week study protocol period.
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Department of Kinesiology
state: Michigan
Study officials:
affiliation: Michigan State University
name: Matthew B Pontifex, PhD.
role: PRINCIPAL_INVESTIGATOR
References: