ADHDGAMESNCT05296473
Guided ADHD Therapy for Managing the Extent and Severity of Symptoms
A study testing ADHD Therapy in people with ADHD, run by Lumos Labs, Inc. at 13 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 22 to 55 years
- Conditions the study is for
- ADHD
- What is being tested?
- ADHD Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 13 sitesUnited States
- Study dates
- 5 May 2022to 12 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
FutureSearch Trials of Dallas
Dallas, Texas, 75231
Duke University
Durham, North Carolina, 27710
CNS Network
Garden Grove, California, 92845
Center of Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128
Alivation Research, LLC
Lincoln, Nebraska, 68526
Accel Research Sites - Maitland Clinical Research Unit
Maitland, Florida, 32751
CNS Healthcare
Memphis, Tennessee, 38119
Mindpath Care Centers
Raleigh, North Carolina, 27606
University of California Davis MIND Institute
Sacramento, California, 95817
Midwest Research Group
Saint Charles, Missouri, 63304
University of California San Francisco
San Francisco, California, 94143
Melmed Center
Scottsdale, Arizona, 85254
About this study
Official title: 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).
- Conditions
- ADHD
- Being tested
- ADHD Therapy, Control Therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADHD TherapyDevice
investigational game-play therapy
Control TherapyDevice
control game-play therapy
| Study group | Role | What they receive |
|---|---|---|
| ADHD Therapy | Experimental | Not described Receives: Device: ADHD Therapy |
| Control Therapy | Active comparator | Not described Receives: Device: Control Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS)
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.
Measured: Study Day 0 to Study Day 63
Secondary outcomes (6)
ADHD-RS-5 Inattention Subscale with Adult Prompts
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.
Measured: Study Day 0 to Study Day 63
Cambridge Brain Sciences Token Search
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.
Measured: Study Day 0 to Study Day 63
Cambridge Brain Sciences Spatial Span
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.
Measured: Study Day 0 to Study Day 63
Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Working Memory and Inhibit Percentiles
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.
Measured: Study Day 0 to Study Day 63
Weiss Functional Impairment Rating Scale - Self-Report (WFIRS-S)
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.
Measured: Study Day 0 to Study Day 63
Clinical Global Impression Scale - Improvement (CGI-I)
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.
Measured: at Study Day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start5 May 2022
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann Childress, MD, Principal investigator, Clinical Research of Southern Nevada, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296473
- Sponsor's protocol ID
- CIP-013
- Acronym
- GAMES
- Status last verified
- Sep 2024
- First submitted
- 16 Mar 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05296473
- Acronym / sponsor ID
- GAMES / CIP-013
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Lumos Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 May 2022 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD Therapy | Experimental | Device: ADHD Therapy |
| Control Therapy | Active comparator | Device: Control Therapy |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADHD Therapyinvestigational game-play therapy | Device | ADHD Therapy |
| Control Therapycontrol game-play therapy | Device | Control Therapy |
Primary outcome
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.
6 secondary outcomes
ADHD-RS-5 Inattention Subscale with Adult Prompts
Time frame: Study Day 0 to Study Day 63
Cambridge Brain Sciences Token Search
Time frame: Study Day 0 to Study Day 63
Cambridge Brain Sciences Spatial Span
Time frame: 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
Weiss Functional Impairment Rating Scale - Self-Report (WFIRS-S)
Time frame: Study Day 0 to Study Day 63
Clinical Global Impression Scale - Improvement (CGI-I)
Time frame: at Study Day 63
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Childress, MD principal investigator
Clinical Research of Southern Nevada, LLC
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADHD Therapy in people with ADHD, run by Lumos Labs, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS) (time frame: Study Day 0 to Study Day 63). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.