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Behavioural Intervention
Guided ADHD Therapy for ADHD (GAMES Trial)
N/A
Waitlist Available
Led By Ann Childress, 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
Confirmed ADHD diagnosis, combined or inattentive type, at Screening based on DSM-5 criteria and established via the MINI-Adult, administered by a trained clinician
Subjects 22-55 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study day 63
Awards & highlights
GAMES Trial Summary
This trial will test a new digital therapy for treating adults with ADHD. The therapy will be delivered through a game, and the goal is to see if it is safe and effective.
Who is the study for?
Adults aged 22-55 with ADHD, an IQ score of at least 80, and a clinician-rated ADHD-RS total score ≥28 can join. They must speak English, not be on certain ADHD medications or agree to stop them if they are, and have daily access to a wireless network. People with severe psychiatric disorders, recent substance abuse, motor conditions that prevent game playing, or who've used similar digital therapies recently cannot participate.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a new at-home digital therapy for adults with ADHD. It's game-based and compared against a control therapy. Participants will use this intervention in their own environment to see if it helps manage their symptoms better than existing methods.See study design
What are the potential side effects?
Since this is a non-pharmacological treatment involving digital games for managing ADHD symptoms, side effects might include discomfort like headaches or dizziness from screen time but are expected to be minimal compared to medication-related side effects.
GAMES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with ADHD, either combined or inattentive type, by a trained clinician.
Select...
I am between 22 and 55 years old.
GAMES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study day 63
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study day 63
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS)
Secondary outcome measures
ADHD-RS-5 Inattention Subscale with Adult Prompts
Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Working Memory and Inhibit Percentiles
Cambridge Brain Sciences Spatial Span
+3 moreGAMES Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ADHD TherapyExperimental Treatment1 Intervention
Group II: Control TherapyActive Control1 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
15,636 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
194 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Ann Childress, MDPrincipal InvestigatorClinical Research of Southern Nevada, LLC
11 Previous Clinical Trials
1,259 Total Patients Enrolled
10 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,247 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not allowed to use certain drugs that affect your brain and behavior during the study, unless they are specifically prescribed by your doctor.I am either male or female.You have had a problem with alcohol or drugs in the past year.I have a history of seizures or significant tics, not including febrile seizures.You are currently at risk of harming yourself, as determined by the screening assessment.You have any other condition that could make it difficult to accurately analyze the study results.Your vision is not clear enough, even with glasses or contact lenses, and it affects your ability to play games.I have been diagnosed with ADHD, either combined or inattentive type, by a trained clinician.I am currently taking non-stimulant medication for ADHD.I have used a digital therapy or brain training app for over two weeks in the last 3 years.I am between 22 and 55 years old.You have experienced negative symptoms like headaches, dizziness, or nausea when playing video games.I am not taking ADHD medication, or I can stop if needed.I have recently started or plan to start behavioral therapy or neurofeedback without changing it during the study.Your ADHD symptom score, as assessed by a doctor, is 28 or higher before starting the study.
Research Study Groups:
This trial has the following groups:- Group 1: ADHD Therapy
- Group 2: Control 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 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT05296473 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies within this clinical trial?
"This clinical trial, which was initially advertised on May 5th 2022, is currently recruiting participants. The details of the study were last updated September 30th 2022 according to data hosted by clinicaltrials.gov."
Answered by AI
Does this trial include elderly participants aged 80 or more?
"Admittance to this trial is limited to individuals between 22 and 55 years of age."
Answered by AI
Who meets the criteria for enrollment in this clinical trial?
"To join this clinical trial, patients must have a confirmed diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) and be between the ages of 22-55. A total of 472 participants are being recruited for the study."
Answered by AI
How many volunteers are engaged in this research project?
"In order to complete the trial, Lumos Labs Inc. needs 472 participants that fulfill its inclusion criteria. The study will be conducted in two sites: UC Davis MIND Institute in Sacramento and FutureSearch Trials of Dallas in Texas."
Answered by AI
How many locations are implementing this research endeavor?
"At present, 10 sites are running this trial. These include Sacramento, Dallas and Lincoln as well as other cities nearby. When considering enrollment in the study, it is recommended to pick a location that has minimal travel requirements for you personally."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
California
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Melmed Center
CNS Network
FutureSearch Trials of Dallas
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
2
3+
What questions have other patients asked about this trial?
What are the benefits? Can this be done virtually? How long do screenings take?
PatientReceived 2+ prior treatments
How will the process go about? Anything closer to Raleigh, NC?
PatientReceived no prior treatments
Why did patients apply to this trial?
are these paid studies? Address medical condition. Tired of letting adhd rule my life.
PatientReceived no prior treatments
Interested in finding the best treatment with results. I have been prescribed many drugs without a good match.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- Alivation Research, LLC: < 24 hours
- Melmed Center: < 24 hours
- Center of Psychiatry and Behavioral Medicine: < 24 hours
Average response time
- < 2 Days
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