ADHDA-GAMESNCT05805176
An Adjunct Study to Assess 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 5 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 18 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
- 194 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Apr 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 22-55 years of age (Cohort I) or 18-21 years of age (Cohort II)
- 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 total score on the DSM 5 Inattentive Symptoms, DSM 5 Hyperactive - Impulsive Symptoms and ADHD Index subscales of the Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) ≥24
- 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
- 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 daily
- Have access to a computer or smart device (e.g., phone, tablet) with internet access and a Google Chrome web browser
- Ability to comply with all the testing and study requirements
Who cannot join
- 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
- Inadequate IQ to participate in the study as estimated by Investigator (i.e., inability to read/understand the informed consent; inability to understand how the device and therapy (games) work)
- PHQ-9 scores ≥16
- 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
Show all 17Show fewer
- 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 ADHD medication) 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
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Hassman Research Institute
Berlin, New Jersey, 08009
Midwest Research Group
Brentwood, Missouri, 63144
CNS Healthcare of Jacksonville
Jacksonville, Florida, 32256
Accel Clinical Research Sites
Lakeland, Florida, 33803
Rochester Center for Behavioral Medicine (RCBM)
Rochester Hills, Michigan, 48307
About this study
Official title: An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of Symptoms - A Prospective, Multicenter, Open Label, Single Arm, Intervention Study to Assess Efficacy and Safety of an At-home, Game-based Digital Therapy for Treating Clinical Symptoms of Adult Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)
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
- 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
| Study group | Role | What they receive |
|---|---|---|
| ADHD Therapy | Experimental | Not described Receives: Device: ADHD Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) Inattentive Symptoms subscale
The Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) has 66 items with multiple subscales.
Measured: Study Day 0 to Study Day 63
Secondary outcomes (3)
Adult ADHD Self-Report Scale (ASRS) Inattentive Symptoms Subscale
The World Health Organization Adult Self-Report Scale (ASRS) symptom checklist is an 18-item tool to screen for probable ADHD in adults. The ASRS checklist asks respondents to indicate how they have felt and conducted themselves over the past 6 months in terms of frequency of inattention or hyperactivity symptoms, which are rated from 0 ("never") to 4 ("very often"). The checklist is divided into two parts and results in a "Part A" inattention subscore (range 0-36), a "Part B" hyperactivity/ impulsivity subscore (range 0-36), and a total score based on the full scale (range 0-72).
Measured: Study Day 0 to Study Day 63
Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) ADHD Symptoms Total subscale
The Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) has 66 items with multiple subscales.
Measured: Study Day 0 to Study Day 63
Sheehan Disability Scale (SDS)
The Sheehan Disability Scale is a five-item, self-rated questionnaire designed to measure the extent to which a patient's disability due to an illness or health problem interferes with work/school, social life/leisure activities, and family life/home responsibilities.
Measured: Study Day 0 to 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 posted7 Apr 2023
- Study start15 Apr 2023
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumos Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Greg Mattingly, MD, Principal investigator, Midwest Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805176
- Sponsor's protocol ID
- CIP-014
- Acronym
- A-GAMES
- Status last verified
- Dec 2024
- First submitted
- 24 Mar 2023
- Last updated
- 31 Dec 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 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of Symptoms - A Prospective, Multicenter, Open Label, Single Arm, Intervention Study to Assess Efficacy and Safety of an At-home, Game-based Digital Therapy for Treating Clinical Symptoms of Adult Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT05805176
- Acronym / sponsor ID
- A-GAMES / CIP-014
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Lumos Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 7 Apr 2023 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD Therapy | Experimental | Device: ADHD Therapy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 22-55 years of age (Cohort I) or 18-21 years of age (Cohort II)
- 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 total score on the DSM 5 Inattentive Symptoms, DSM 5 Hyperactive - Impulsive Symptoms and ADHD Index subscales of the Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) ≥24
- 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
- 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)
Key exclusion criteria (17 listed)
- 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
- Inadequate IQ to participate in the study as estimated by Investigator (i.e., inability to read/understand the informed consent; inability to understand how the device and therapy (games) work)
- PHQ-9 scores ≥16
- 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
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 |
Primary outcome
Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) Inattentive Symptoms subscale
Time frame: Study Day 0 to Study Day 63
The Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) has 66 items with multiple subscales.
3 secondary outcomes
Adult ADHD Self-Report Scale (ASRS) Inattentive Symptoms Subscale
Time frame: Study Day 0 to Study Day 63
Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) ADHD Symptoms Total subscale
Time frame: Study Day 0 to Study Day 63
Sheehan Disability Scale (SDS)
Time frame: Study Day 0 to Study Day 63
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 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.
Greg Mattingly, MD principal investigator
Midwest Research Group
5 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 5 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 8 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
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?
Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) Inattentive Symptoms subscale (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 31 Dec 2024.