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Gameplay Therapy for Attention Deficit Hyperactivity Disorder (ADHD) (A-GAMES Trial)
N/A
Recruiting
Led By Greg Mattingly, MD
Research Sponsored by Lumos Labs, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 22-55 years (Cohort I) or 18-21 years (Cohort II)
Current, stable use of an FDA approved pharmacological treatment for ADHD for at least 4 weeks prior to screening, but ADHD condition inadequately managed by that medication
Must not have
Any use of psychoactive drugs (other than ADHD medication) that in the opinion of the Investigator may confound study data/assessments
Unstable/uncontrolled, comorbid psychiatric diagnosis, based on clinical interviewing, with significant current active symptoms including but not limited to posttraumatic stress disorder, schizophrenia spectrum and other psychotic disorders, bipolar disorder, autism spectrum disorder, severe obsessive-compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments
Timeline
Screening 1 day
Treatment 13 weeks
Follow Up 1 day
Awards & highlights
A-GAMES Trial Summary
This trial tests a digital game-based therapy to treat adults with ADHD. Results will show if it's safe and effective.
Who is the study for?
Adults aged 18-55 with ADHD, who can follow English instructions and have stable internet access for at-home digital therapy. Participants must be on steady ADHD medication but still experience symptoms. Excluded are those with recent substance abuse, high depression scores, or a history of seizures among other criteria.Check my eligibility
What is being tested?
The trial is testing an at-home game-based digital therapy to see if it helps adults manage their ADHD symptoms better. It's designed for those whose current medications aren't fully effective.See study design
What are the potential side effects?
Potential side effects may include discomforts related to video game use such as headaches, dizziness, or nausea. The study excludes individuals known to be sensitive to playing video games.
A-GAMES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are within the age range of 22-55 years (for Cohort I) or 18-21 years (for Cohort II).
Select...
You have been using a certified medication to address your ADHD for the past 4 weeks and it has not sufficiently regulated your condition.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
You cannot take any psychoactive drugs (except for ADHD medication) that could affect the accuracy of the study's data and assessments, as determined by the researcher.
Select...
You have a mental health condition that is not under control and may interfere with the study, such as severe depression, anxiety, PTSD, schizophrenia, bipolar disorder, or other serious mental health disorders.
A-GAMES Trial Timeline
Screening ~ 1 day0 visits
Treatment ~ 13 weeks1 visit
Follow Up ~ 1 day0 visits
Screening ~ 1 day
Treatment ~ 13 weeks
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) Inattentive Symptoms subscale
Secondary outcome measures
Adult ADHD Self-Report Scale (ASRS) Inattentive Symptoms Subscale
Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) ADHD Symptoms Total subscale
Sheehan Disability Scale (SDS)
A-GAMES Trial Design
1Treatment groups
Experimental Treatment
Group I: ADHD TherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ADHD Therapy
2022
N/A
~560
Find a Location
Who is running the clinical trial?
Lumos Labs, Inc.Lead Sponsor
13 Previous Clinical Trials
16,002 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
560 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Greg Mattingly, MDPrincipal InvestigatorMidwest Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been using a certified medication to address your ADHD for the past 4 weeks and it has not sufficiently regulated your condition.You are within the age range of 22-55 years (for Cohort I) or 18-21 years (for Cohort II).Your family member or close friend is already participating in this study.You have participated in another clinical trial within the last three months before screening.Your vision is so poor that you cannot play the game or it affects your ability to play the game properly.You have attained a minimum score of 24 on the Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) comprising DSM 5 Inattentive Symptoms, DSM 5 Hyperactive - Impulsive Symptoms and ADHD Index subscales.You possess the capacity to comprehend and converse in English, comply with written or spoken commands (English), as evaluated by the Principal Investigator and/or Study Coordinator, and give knowledgeable consent (English).The researcher thinks that your other health conditions could make it difficult to accurately interpret study results.You must be able to routinely access a wireless network with your devices.You have had problems with alcohol or drug addiction in the past year.You have experienced headaches, dizziness, or nausea from playing video games in the past.You have access to a device with internet and Google Chrome capability.You cannot have started behavioral therapy or neurofeedback within the last 4 weeks or plan to start it during the study. If you have been consistently receiving therapy for more than 4 weeks, you may participate as long as you do not plan to change your routine during the study. If you plan to change or start therapy during the study, you cannot participate.You have a mental health condition that is not under control and may interfere with the study, such as severe depression, anxiety, PTSD, schizophrenia, bipolar disorder, or other serious mental health disorders.You have a history of seizures (excluding those caused by fever), or significant uncontrollable movements or sounds like those seen in Tourette's syndrome or epilepsy triggered by lights.You have a physical condition that makes it difficult for you to play the game, such as deformities in your hands or arms, or if you use prosthetics.You are capable of fulfilling all the trial and research obligations.You have been assessed by a trained clinician and diagnosed with ADHD in accordance to DSM-5 standards.You cannot take any psychoactive drugs (except for ADHD medication) that could affect the accuracy of the study's data and assessments, as determined by the researcher.You have used a video game-like digital therapy or brain training platform for more than two weeks in the last three years.You have expressed suicidal thoughts or behaviors according to a screening questionnaire (C-SSRS) completed by the investigator.
Research Study Groups:
This trial has the following groups:- Group 1: ADHD Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 13 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT05805176 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can applicants aged younger than 55 partake in this experiment?
"In line with the criteria for inclusion, participants must be aged between 18 and 55 years old."
Answered by AI
What are the qualifying criteria for participants of this research initiative?
"This trial has a specified criteria for eligibility: participants must have been diagnosed with attention deficit hyperactivity disorder (ADHD) and be between 18-55 years old. A total of 194 individuals are required to complete the study."
Answered by AI
Are applications for this experiment currently being accepted?
"Affirmative. The details found on clinicaltrials.gov demonstrate that recruitment for this experiment is ongoing, with the trial first posted on March 30th 2023 and last updated on March 28th 2023. This project requires 194 individuals to be recruited from two separate healthcare facilities."
Answered by AI
What is the scale of participants in this experiment?
"Affirmative, according to the information on clinicaltrials.gov this research effort is still accepting participants. It was originally published on March 30th 2023 and revised two days ago, with a target of 194 patients in 2 locations."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Ohio
Michigan
Other
What site did they apply to?
Midwest Research Group
Other
Accel Clinical Research Sites
Rochester Center for Behavioral Medicine (RCBM)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
1
Why did patients apply to this trial?
I am wanting to do if have adhd. Want something to help me with adhd. I am really wanting to learn more about how to manage my ADHD and also do trials to help better understand this diagnosis to make it easier for people in the future. I also continuously have issues keeping jobs and keeping my brain motivated.
PatientReceived 1 prior treatment
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