Back to resultsEfficacy of the Apollo System for Children With ADHD
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
8 weeks of home based use.
Sponsored by
About this trial
This is an interventional supportive care trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Inhibition, Vibrational therapy
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:
- 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.
Sites / Locations
- Department of KinesiologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Commercial Apollo System Device
Sham Apollo System Device
Arm Description
The active experimental group received the commercial Apollo System device.
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.
Outcomes
Primary Outcome Measures
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.
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05308706
First Posted
March 24, 2022
Last Updated
March 24, 2022
Sponsor
Michigan State University
Collaborators
The Board of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05308706
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2022 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
The Board of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD, Inhibition, Vibrational therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
Double blind, sham/placebo controlled trial.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Commercial Apollo System Device
Arm Type
Experimental
Arm Description
The active experimental group received the commercial Apollo System device.
Arm Title
Sham Apollo System Device
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
8 weeks of home based use.
Intervention Description
Use of the devices for an 8 week study period. Devices are preset to follow a scheduled activation pattern during the day.
Primary Outcome Measure Information:
Title
Change in ADHD symptomatology as assessed using the ADHD-5 Rating Scale
Description
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.
Time Frame
Prior to and following the 8 week study protocol period.
Title
Effect Size for Change in Behavioral Index of Interference Control
Description
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).
Time Frame
Prior to and following the 8 week study protocol period.
Title
Effect Size for Change in Behavioral Index of Response Inhibition
Description
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).
Time Frame
Prior to and following the 8 week study protocol period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew B Pontifex, PhD
Phone
517-432-5105
Email
pontifex@msu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew B Pontifex, PhD.
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Kinesiology
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew B Pontifex, Ph.D.
Phone
517-432-5105
Email
pontifex@msu.edu
First Name & Middle Initial & Last Name & Degree
Matthew B Pontifex, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.
IPD Sharing Time Frame
Data will be available following primary publication of the results.
IPD Sharing Access Criteria
By request and completion of an institutional data-safety and sharing agreement.
Learn more about this trial
Efficacy of the Apollo System for Children With ADHD
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