Active — Not RecruitingNot Applicable

Efficacy of the Apollo System for Children With ADHD

United States100 participantsStarted 2022-03-18

Plain-language summary

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

Age range8 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

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

Timeframe: Prior to and following the 8 week study protocol period.

Effect Size for Change in Behavioral Index of Interference Control

Timeframe: Prior to and following the 8 week study protocol period.

Effect Size for Change in Behavioral Index of Response Inhibition

Timeframe: Prior to and following the 8 week study protocol period.

NCT IDNCT05308706

SponsorMichigan State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-15

Who can participate

Age range8 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

What they're measuring

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

Timeframe: Prior to and following the 8 week study protocol period.

Effect Size for Change in Behavioral Index of Interference Control

Timeframe: Prior to and following the 8 week study protocol period.

Effect Size for Change in Behavioral Index of Response Inhibition

Timeframe: Prior to and following the 8 week study protocol period.