What side effects are associated with this type of intervention?

Common treatments for ADHD include stimulant medications like methylphenidate and amphetamines, which can cause side effects such as increased heart rate, elevated blood pressure, insomnia, decreased appetite, and potential cardiovascular issues. Non-pharmacological interventions, such as virtual reality-based games aimed at cognitive skill enhancement, are generally well-tolerated but may cause mild side effects like motion sickness, eye strain, and headaches. Cognitive behavioral therapies typically have minimal side effects but require consistent participation and engagement for effectiveness.

What prior FDA approvals exist?

The FDA has approved several treatments for ADHD, including stimulant medications like methylphenidate and amphetamines, which are commonly used to manage core symptoms. Additionally, Akili Interactive's EndeavorRx, a video game therapy, has been approved by the FDA for treating children with ADHD. This treatment is similar to the virtual reality-based games being studied, as both involve cognitive skill enhancement through repeated practice and stimulation.

What other types of research exist?

Promising alternatives to Virtual Reality-Based Games for ADHD treatment include online chess, which has shown efficacy in clinically drug-stable patients, and cognitive remediation programs that focus on improving cognitive skills through structured tasks. Additionally, traditional psychostimulant medications like methylphenidate remain effective for managing ADHD symptoms.

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Virtual Reality Therapy for ADHD

Phase 1 & 2

Recruiting

Led By Wallace P Shaw, M.D.

Research Sponsored by National Human Genome Research Institute (NHGRI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within one month of the end of vr training

Awards & highlights

Summary

This trial tests if a virtual reality game can improve thinking and brain function in children with ADHD.

Who is the study for?

This trial is for children aged 7 to 14 with ADHD, who can follow the study's procedures and are stable on medication if they're taking any. It excludes those with cognitive impairments, severe migraines, vertigo, epilepsy or serious balance disorders, poor uncorrected vision, pregnancy, psychotic disorders or substance dependence.Check my eligibility

What is being tested?

The trial tests a virtual reality-based game using Floreo VR applications designed to improve attention and cognitive skills in kids with ADHD. Participants play games that target specific skills like inhibition control for several weeks while their brain function is monitored.See study design

What are the potential side effects?

Potential side effects from participating in this trial include motion sickness, eye strain or headaches as reported by participants during weekly interviews.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within one month of the end of vr training

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within one month of the end of vr training

This trial's timeline: 3 weeks for screening, Varies for treatment, and within one month of the end of vr training for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ADHD-RS-5 inattention sub-scale.

Secondary outcome measures

Matrix Bands

Number of correct responses on the NIH Toolbox Pattern Comparison Processing Speed Test.

Stop signal reaction time on the Stop Signal task (inhibitory control)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Floreo VR groupExperimental Treatment1 Intervention

This group will undergo up to 20 daily sessions (20 minutes each) of the Floreo VR training.

Do I qualify?Apply below to find out

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

Common treatments for ADHD include stimulant medications, behavioral therapy, and cognitive training. Stimulant medications, such as methylphenidate and amphetamines, work by increasing the levels of dopamine and norepinephrine in the brain, which helps improve attention and reduce impulsivity and hyperactivity. Behavioral therapy focuses on modifying behavior through reinforcement strategies. Cognitive training, including virtual reality-based games, aims to enhance cognitive skills like working memory, processing speed, and inhibitory control through repeated practice and stimulation. These treatments are crucial for ADHD patients as they address core symptoms and improve daily functioning, educational outcomes, and social interactions.

A Virtual Reality Serious Videogame Versus Online Chess Augmentation in Patients with Attention Deficit Hyperactivity Disorder: A Randomized Clinical Trial.Comparing the Effects of Drug Therapy, Perceptual Motor Training, and Both Combined on the Motor Skills of School-Aged Attention Deficit Hyperactivity Disorder Children.Psychosocial treatments for adults with attention-deficit/hyperactivity disorder.

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Who is running the clinical trial?

National Human Genome Research Institute (NHGRI)Lead Sponsor

263 Previous Clinical Trials

283,930 Total Patients Enrolled

3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

5,672 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Wallace P Shaw, M.D.Principal InvestigatorNational Human Genome Research Institute (NHGRI)

2 Previous Clinical Trials

2,191 Total Patients Enrolled

2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

2,191 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Floreo Virtual Reality application Clinical Trial Eligibility Overview. Trial Name: NCT05608434 — Phase 1 & 2

Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Floreo VR group

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Floreo Virtual Reality application Highlights & Side Effects. Trial Name: NCT05608434 — Phase 1 & 2

Floreo Virtual Reality application 2023 Treatment Timeline for Medical Study. Trial Name: NCT05608434 — Phase 1 & 2

~146 spots leftby Dec 2025

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