What side effects are associated with this type of intervention?

Common treatments for ADHD include stimulant medications, non-stimulant medications, and behavioral therapies. Stimulant medications like methylphenidate and amphetamines can cause side effects such as insomnia, decreased appetite, weight loss, and increased heart rate. Non-stimulant medications like atomoxetine and guanfacine may cause fatigue, dry mouth, and dizziness. Behavioral therapies, including game-based digital therapy, generally have fewer side effects but may include temporary frustration or anxiety as patients adapt to new routines and strategies. Digital therapies are well-tolerated and can improve adherence to treatment while reducing core symptoms of ADHD.

What other types of research exist?

Promising novel alternatives to game-based digital therapy for ADHD patients include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown efficacy in improving inattention in adults with ADHD. 2) Virtual Reality Serious Videogames, which have been effective in clinically drug-stable patients with ADHD. 3) Online Chess Augmentation, which has also demonstrated efficacy in drug-stable ADHD patients. These alternatives offer diverse approaches, from non-invasive brain stimulation to interactive and cognitive training methods.

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Behavioural Intervention

Guided ADHD Therapy for ADHD (GAMES Trial)

Q: What prior FDA approvals exist?

The FDA has approved Akili Interactive's EndeavorRx as a game-based digital therapy for children with ADHD. This treatment engages patients through interactive game mechanics to improve attention and reduce hyperactivity/impulsivity. Additionally, traditional pharmacological treatments for ADHD include stimulant medications such as methylphenidate and amphetamines, which are commonly used to manage symptoms.

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

Must not have

History of seizures (excluding febrile seizures), or significant motor or vocal tics, including but not limited to Tourette's Disorder and photo-sensitive epilepsy

Patients who are currently treated with a non-stimulant medication for ADHD (i.e., atomoxetine, clonidine, guanfacine, viloxazine)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at study day 63

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a video game that adults with ADHD can play at home to help manage their symptoms. The game aims to improve attention and reduce hyperactivity by training the brain. Researchers are studying if this new approach is safe and effective. The Secret Trail of Moon (TSTM) is a virtual reality game designed for cognitive training related to core ADHD symptoms and executive dysfunction.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with ADHD, either combined or inattentive type, by a trained clinician.

Select...

I am between 22 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of seizures or significant tics, not including febrile seizures.

Select...

I am currently taking non-stimulant medication for ADHD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at study day 63

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at study day 63

This trial's timeline: 3 weeks for screening, Varies for treatment, and at study day 63 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS)

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ADHD include stimulant medications (e.g., methylphenidate and amphetamines), non-stimulant medications (e.g., atomoxetine), and behavioral therapies. Stimulant medications work by increasing the levels of dopamine and norepinephrine in the brain, which helps improve attention and reduce hyperactivity and impulsivity. Non-stimulant medications, like atomoxetine, selectively inhibit the reuptake of norepinephrine, enhancing attention and impulse control. Behavioral therapies, such as cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT), focus on developing coping strategies and improving executive function. Game-based digital therapies engage patients through interactive game mechanics to improve attention and reduce hyperactivity/impulsivity by providing a structured and stimulating environment that encourages focus and self-regulation. These treatments are crucial for ADHD patients as they address core symptoms, improve daily functioning, and enhance overall quality of life.

Serious Video Games: Angels or Demons in Patients With Attention-Deficit Hyperactivity Disorder? A Quasi-Systematic Review.