- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05296473
Guided ADHD Therapy for Managing the Extent and Severity of Symptoms (GAMES)
March 14, 2024 updated by: Lumos Labs, Inc.
Guided ADHD Therapy for Managing the Extent and Severity of Symptoms - A Randomized, Controlled, Parallel-group, Intervention Study to Assess an At-home, Game-based Digital Therapy for Treating Adult Patients With Attention-Deficit/Hyperactivity Disorder
The objective of this study is to assess the safety and effectiveness of an at-home, game-based digital therapy for treating adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
560
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bob Schafer, PhD
- Phone Number: (530) 746-8565
- Email: bschafer@lumoslabs.com
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85254
- Melmed Center
-
-
California
-
Garden Grove, California, United States, 92845
- CNS Network
-
Sacramento, California, United States, 95817
- University of California Davis MIND Institute
-
San Francisco, California, United States, 94143
- University of California San Francisco
-
-
Florida
-
Maitland, Florida, United States, 32751
- Accel Research Sites - Maitland Clinical Research Unit
-
-
Missouri
-
Saint Charles, Missouri, United States, 63304
- Midwest Research Group
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68526
- Alivation Research, LLC
-
-
Nevada
-
Las Vegas, Nevada, United States, 89128
- Center of Psychiatry and Behavioral Medicine
-
-
New Jersey
-
Cherry Hill, New Jersey, United States, 08002
- Center for Emotional Fitness
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University
-
Raleigh, North Carolina, United States, 27606
- Mindpath Care Centers
-
-
Tennessee
-
Memphis, Tennessee, United States, 38119
- CNS Healthcare
-
-
Texas
-
Dallas, Texas, United States, 75231
- FutureSearch Trials of Dallas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Subjects 22-55 years of age
- Male or female
- 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
- Baseline score on the clinician-rated ADHD-RS total score ≥28
- Not undergoing pharmacological treatment with methylphenidate or amphetamine-based products at time of Screening; or, if undergoing pharmacological treatment, must be willing and appropriate (i.e., not optimally treated in the Investigator's judgement or having issues with tolerability) to wash out of current regimen
- Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
- Ability to understand and speak English, follow written and verbal instructions (English), as assessed by the PI and/or Study Coordinator, and give informed consent (English)
- Have ability to connect wireless devices to a functional wireless network on a daily basis
- Ability to comply with all the testing and study requirements
Exclusion Criteria:
- Current, controlled (requiring restricted medication) or uncontrolled, comorbid psychiatric diagnosis, based on MINI-Adult and subsequent clinical interviewing, with significant symptoms including but not limited to posttraumatic stress disorder, psychosis, bipolar illness, pervasive developmental 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.
- Patients who are currently treated with a non-stimulant medication for ADHD (i.e., atomoxetine, clonidine, guanfacine, viloxazine)
- Have previously been assessed by TOVA for potential enrollment in a clinical trial.
- Have previously used a videogame-like digital therapy (e.g., Akili EndeavorRxTM) OR Within the last three years, have used a cognitive or brain training platform (e.g., Peak, Brain HQ, Lumosity, Atentiv) for more than two weeks duration
- Known sensitivity to playing video games, such as headaches, dizziness, nausea.
- Initiation within the last 4 weeks of behavioral therapy or neurofeedback, or planned initiation during the study. Patients who have been in behavior therapy or neurofeedback consistently for more than 4 weeks may participate provided their routine is unchanged during the course of the study. Patients planning on changing or initiating behavior therapy or neurofeedback during the course of the study will be excluded.
- Patient is currently considered a suicide risk in the opinion of the Investigator, as measured by C-SSRS at screening (i.e., score of 4 or 5 on C-SSRS)
- Motor condition (e.g., physical deformity of the hands/arms; protheses) that prevents game playing as observed by the Investigator
- Recent history (within the past 12 months) of suspected alcohol or substance abuse or dependence
- Positive urine drug screen
- History of seizures (excluding febrile seizures), or significant motor or vocal tics, including but not limited to Tourette's Disorder and photo-sensitive epilepsy
- Visual acuity that cannot be corrected that prevents or negatively impacts game playing as observed by the Investigator
- Any use of psychoactive drugs (other than stimulant) that in the opinion of the Investigator may confound study data/assessments
- Has participated in a clinical trial within 90 days prior to screening
- Has a family member or close friend/associate also enrolled/currently participating in the same study
- Any other condition that in the opinion of the Investigator may confound study data/assessments
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Therapy
|
control game-play therapy
|
Experimental: ADHD Therapy
|
investigational game-play therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS)
Time Frame: Study Day 0 to Study Day 63
|
The TOVA is a standardized, computerized, continuous performance test (CPT).
The TOVA Attention Comparison Score (ACS) is a comparison of a subject's scores to scores from a normative ADHD population.
A score of < 0 indicates a subject's performance is similar to that of the normative ADHD population, with a lower score indicating a more severe ADHD profile.
A positive change on the TOVA ACS from Day 0 to Day 63 indicates improvement.
|
Study Day 0 to Study Day 63
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADHD-RS-5 Inattention Subscale with Adult Prompts
Time Frame: Study Day 0 to Study Day 63
|
The ADHD-RS-5 with Adult Prompts is an 18-item, clinician-administered questionnaire that rates the frequency of occurrence of ADHD symptoms and behaviors as defined by criteria outlined for ADHD in the DSM-5.
Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms).
The first 9 items assess inattention symptoms and the last 9 items assess hyperactive-impulsive symptoms.
Each subscale produces a sub-scale score ranging from 0-27.
A higher subscale score indicates more severe ADHD symptoms and behaviors.
A negative change on the inattention subscale from Day 0 to Day 63 indicates improvement.
|
Study Day 0 to Study Day 63
|
Cambridge Brain Sciences Token Search
Time Frame: Study Day 0 to Study Day 63
|
Token Search is a computerized task designed to assess working memory.
In Token Search, subjects identify the location of a hidden token in a set of boxes while remembering where previous tokens have been found.
Correctly finding a token in every box will increase difficulty level in the form of a new puzzle with an increased number of boxes.
Performance is indicated by the average number of tokens found.
A positive change in score on the Token Search task from Day 0 to Day 63 indicates improvement.
|
Study Day 0 to Study Day 63
|
Cambridge Brain Sciences Spatial Span
Time Frame: Study Day 0 to Study Day 63
|
Spatial Span is a computerized task designed to assess spatial short-term memory and based on the Corsi Block tapping task.
In Spatial Span, subjects are shown a sequence of flashing boxes and have to repeat the sequence.
Sequence lengths increase with correct answers.
Performance is indicated by the average number of boxes remembered during the task.
A positive change in score on the Spatial Span ask from Day 0 to Day 63 indicates improvement.
|
Study Day 0 to Study Day 63
|
Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Working Memory and Inhibit Percentiles
Time Frame: Study Day 0 to Study Day 63
|
The BRIEF-A is composed of 75 items within nine non-overlapping theoretically and empirically derived clinical scales that measure various aspects of executive functioning.
Each item is rated as either 1 (never), 2 (sometimes), or 3 (often).
A reduction in score from Day 0 to Day 63 indicates improvement.
|
Study Day 0 to Study Day 63
|
Weiss Functional Impairment Rating Scale - Self-Report (WFIRS-S)
Time Frame: Study Day 0 to Study Day 63
|
The WFIRS-S is a validated rating scale used to capture functional difficulties in the lives of individuals with ADHD in 7 domains.
Each item is scored on a 4-point scale ranging from 0 (Never or not at all) to 3 (Very often of very much).
A reduction in score from Day 0 to Day 63 indicates improvement.
|
Study Day 0 to Study Day 63
|
Clinical Global Impression Scale - Improvement (CGI-I)
Time Frame: at Study Day 63
|
The Clinical Global Impression Scale-Improvement (CGI-I) is a clinician's comparison of the participant's overall clinical condition at follow-up to the overall clinical condition at baseline.
The CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
A score of 1 (very much improved) or 2 (much improved) or 3 (minimally improved) would indicate overall improvement of ADHD severity.
|
at Study Day 63
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ann Childress, MD, Clinical Research of Southern Nevada, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2022
Primary Completion (Actual)
March 12, 2024
Study Completion (Actual)
March 12, 2024
Study Registration Dates
First Submitted
March 16, 2022
First Submitted That Met QC Criteria
March 16, 2022
First Posted (Actual)
March 25, 2022
Study Record Updates
Last Update Posted (Actual)
March 18, 2024
Last Update Submitted That Met QC Criteria
March 14, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- CIP-013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on ADHD
-
The Hong Kong Polytechnic UniversityRecruiting
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Recruiting
-
VIZO Specs LtdRecruiting
-
Loewenstein HospitalWingate InstituteRecruiting
-
Florida State UniversityRecruiting
-
Florida International UniversityRecruiting
-
Region Örebro CountyRecruiting
-
Johns Hopkins UniversityWithdrawn
-
Tris Pharma, Inc.Premier Research Group plcCompleted
Clinical Trials on ADHD Therapy
-
Lumos Labs, Inc.Recruiting
-
University of IcelandActive, not recruitingAttention-deficit HyperactivityIceland
-
ArkinFonds NutsOhraCompletedAttention Deficit Hyperactivity Disorder | Substance Use DisordersNetherlands
-
Columbia UniversityCompletedAttention Deficit Hyperactivity DisorderUnited States
-
Northwell HealthThe City College of New YorkRecruiting
-
The University of Hong KongRecruiting
-
Göteborg UniversityCompleted
-
Hong Kong Baptist UniversityUniversity Grants Committee, Hong KongCompletedAttention-deficit/Hyperactivity Disorder | Special Education | Attention Deficit Disorder | Special Needs Children | Hyperactivity DisorderHong Kong
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH)CompletedAttention Deficit Disorder With HyperactivityUnited States
-
Children's Hospital Medical Center, CincinnatiTerminated