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New treatment option for ADHD
Official title A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.
ClinicalTrials.gov ID: NCT06728969
What this study is testing
- What it's testing
- This study aims to demonstrate the accuracy of the MT1 algorithm using the MindTension biometric sensor device as a diagnostic aid for healthcare providers in diagnosing ADHD in youth ages ≥ 6 to ≤17 years.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17. Healthy volunteers may be eligible.
You may be able to join if
- Parent provision of signed and dated informed consent form
- Child stated willingness to comply with all study procedures and availability for the duration of the study
- Any gender, aged 6 to 17 years
- Stimulant naïve or willing to wash out of stimulant for 3 days (approximately 72 hours) prior to testing with biometric and performance devices...
- ADHD Group: Diagnosed with symptoms consistent with ADHD as determined by Mini Kid + an ADHD-RS score of 1.5SD above mean for age and sex
You likely can't join if
- Current use of psychotropic medications that cannot be washed out in 3 days (approximately 72 hours)
- Known current seizure disorder (history of febrile seizure allowed).
- Presence of specific devices (e.g., cardiac pacemaker) that may interfere with the MindTension monitor
- IQ\<70 by clinician judgment
- Meeting FULL criteria for current PTSD, GAD, MDD, or any lifetime diagnosis of ASD, Bipolar disorder, or psychotic disorder that was, in the opinion...
- Deaf or hearing impaired, since this will make it difficult to hear and respond to the auditory stimuli.
See the full eligibility criteria
- Parent provision of signed and dated informed consent form
- Child stated willingness to comply with all study procedures and availability for the duration of the study
- Any gender, aged 6 to 17 years
- Stimulant naïve or willing to wash out of stimulant for 3 days (approximately 72 hours) prior to testing with biometric and performance devices (MindTension + TOVA)
- ADHD Group: Diagnosed with symptoms consistent with ADHD as determined by Mini Kid + an ADHD-RS score of 1.5SD above mean for age and sex
- Control group: No diagnosable disorder on the Mini kid, and an ADHD-RS score within 1SD of the mean for age and sex.
- Current use of psychotropic medications that cannot be washed out in 3 days (approximately 72 hours)
- Known current seizure disorder (history of febrile seizure allowed).
- Presence of specific devices (e.g., cardiac pacemaker) that may interfere with the MindTension monitor
- IQ\<70 by clinician judgment
- Meeting FULL criteria for current PTSD, GAD, MDD, or any lifetime diagnosis of ASD, Bipolar disorder, or psychotic disorder that was, in the opinion of the investigator, correctly obtained. May have symptoms of anxiety...
- Deaf or hearing impaired, since this will make it difficult to hear and respond to the auditory stimuli.
- Inability to complete the assessments.
- Any other concerns in the judgment of the PI.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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, 6 years to 17 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, 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.