A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.
Recruiting · NCT06728969 · Interventional (participants receive a specific treatment) · Lead sponsor: MindTension
View the official record on ClinicalTrials.gov →Interventions studied
MT1 Auditory startle response patterns analysis algorithmT.O.V.A. Continuous Performance Test
What this trial is about
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.
Who can take part
Age range
6 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion 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.
Exclusion criteria
- 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 or dysthymia/depression not meeting criteria for a full disorder, or disorders such as simple phobia
- 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.
Where it is running
1 location listed across 1 US state.
- Icahn School of Medicine at Mount Sinai - New York, New York, United States