Recruiting

Diagnostic Aid

Sponsor:

MindTension

Code:

NCT06728969

Conditions

ADHD

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Accepted

Interventions

MT1 Auditory startle response patterns analysis algorithm

T.O.V.A. Continuous Performance Test

Study Details

Brief summary:

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.

Conditions

ADHD

Study ID

NCT06728969

Start date

Jun 2, 2024

Status verified date

Nov, 2024

Completion date

Jun, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Parent provision of signed and dated informed consent form
2. Child stated willingness to comply with all study procedures and availability for the duration of the study
3. Any gender, aged 6 to 17 years
4. 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)
5. 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
6. 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:

1. Current use of psychotropic medications that cannot be washed out in 3 days (approximately 72 hours)
2. Known current seizure disorder (history of febrile seizure allowed).
3. Presence of specific devices (e.g., cardiac pacemaker) that may interfere with the MindTension monitor
4. IQ<70 by clinician judgment
5. 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
6. Deaf or hearing impaired, since this will make it difficult to hear and respond to the auditory stimuli.
7. Inability to complete the assessments.
8. Any other concerns in the judgment of the PI.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: ADHD group

Subjects will be evaluated for ADHD using clinically established reference standard interviews and psychometric tools with demonstrated validity, including the K-SADS and ADHD-RS-5, in accordance with DSM-5 criteria. IQ will be estimated using two subtests of the WASI.

experimental: Non-ADHD group

Subjects will be evaluated using clinically established reference standard interviews and psychometric tools with demonstrated validity, including the K-SADS and ADHD-RS-5, in accordance with DSM-5 criteria. IQ will be estimated using two subtests of the WASI.

Interventions

MT1 Auditory startle response patterns analysis algorithm

Objective measurements of attention and inhibition.

T.O.V.A. Continuous Performance Test

Objective measurements of attention and inhibitory control.

Primary outcome measure

  • Overall Agreement Rate (OAR) - probability that the test will be normal and the condition is normal or positive and the condition is positive, out of all subjects. [ Time Frame: From the beginning of clinical assessment until the end of testing (approximately 1-2 days). ]

Central Contacts and Locations

Central contacts

Jeffrey Newcorn, MD Professor

212-659-8705jeffrey.newcorn@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Beth Krone Clinical Psychologist, PhD., MS

212 241 8012beth.krone@mssm.edu

More Information

Sponsor

MindTension

Last update posted

Dec 11, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MindTension on 2024-12-11.