BridgeMD
New treatment option for Attention Deficit Hyperactivity Disorder
Official title Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Phase I and Randomized Controlled Phase II Trial
ClinicalTrials.gov ID: NCT05608434
What this study is testing
- What it's testing
- Background: Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems. It may be hard for them to control their behaviors, concentrate for long periods, or make decisions.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 16
You may be able to join if
- In order to be eligible to participate, an individual must meet all of the following criteria:
- Children must provide informed assent and parents must provide informed consent to participate in the study.
- Any sex assigned at birth, or race/ethnicity.
- Aged between 8 and 16 years of age, including all months leading up to age 17.
- Meets diagnosis for ADHD, predominately inattentive or combined presentations, or a specified presentation of having prominent symptoms of...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Cognitively not capable of performing study procedures. Indications of a lack of cognitive capacity could include a known IQ under 70, or a history...
- History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders.
- Impairments in uncorrected visual acuity that would interfere with engagement with the VR training.
- Known to be pregnant.
- Psychotic disorders (including schizophrenia, psychosis not otherwise specified), current substance dependence. Other psychiatric disorders elicited...
See the full eligibility criteria
- In order to be eligible to participate, an individual must meet all of the following criteria:
- Children must provide informed assent and parents must provide informed consent to participate in the study.
- Any sex assigned at birth, or race/ethnicity.
- Aged between 8 and 16 years of age, including all months leading up to age 17.
- Meets diagnosis for ADHD, predominately inattentive or combined presentations, or a specified presentation of having prominent symptoms of inattention that are impairing in two or more settings (but not numerous enough...
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.
- For the Pilot only: If treated for ADHD with psychostimulants, willing to withdraw medication three days prior to baseline assessments and to stay off medication until completion of the post-intervention assessment. Not...
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Cognitively not capable of performing study procedures. Indications of a lack of cognitive capacity could include a known IQ under 70, or a history from the screening interview that implies global intellectual...
- History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders.
- Impairments in uncorrected visual acuity that would interfere with engagement with the VR training.
- Known to be pregnant.
- Psychotic disorders (including schizophrenia, psychosis not otherwise specified), current substance dependence. Other psychiatric disorders elicited on the interview are not considered exclusionary provided that ADHD is...
- Considered a suicide risk as determined during the clinical interview at baseline.
- Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments (e.g., limitations in mobility that would render the VR headset unusable).
- Recent (within three months) treatment with other cognitive training interventions (e.g., Cogmed) for ADHD.
- The VR equipment produces excessive discomfort to the child in the opinion of the PI (e.g., including participants with small interpupillary distances (IPD) that are only able to see blurry images on the VR headset, or...
- For the main trial only: Certain psychotropic medications classes that are likely to interfere with the completion of the intervention are exclusionary: antipsychotics, mood stabilizers (lithium, valproate, lamotrigine...
- For the main trial only: Prior use of Floreo s products including but not limited to their ADHD cognitive training application.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.