ADHDNCT06728969
A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.
A study testing MT1 Auditory startle response patterns analysis algorithm and T.O.V.A. Continuous Performance Test in people with ADHD, run by MindTension at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- MT1 Auditory startle response patterns analysis algorithm and T.O.V.A. Continuous Performance Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Beth Krone Clinical Psychologist, PhD., MS, 212 241 8012, beth.krone@mssm.edu
Jeffrey Newcorn Director Division of ADHD and Learning Disorders; Director Ped, MD Professor
About this study
Official title: A Prospective Comparative Study to Evaluate a Novel Algorithm Using Data Derived from a Non-Invasive Digital Biomarker As a Diagnostic Aid for ADHD in Youth Ages 6-17.
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.
Read the detailed description
The study aims to demonstrate the accuracy of the MT1 algorithm. The output of the MT1 algorithm will be compared to a Gold Standard clinical diagnosis made by specialist clinician diagnosis supported by the Kiddie SADS Present and Lifetime semi-structured interview (K-SADS-PL) and norm-referenced measures of current ADHD symptom frequency and severity using the ADHD-RS-5 rating scale. Diagnosis will be scaled according to the Diagnostic and Statistical Manual of Mental Disorders- 5 (DSM-5) criteria, and made with agreement between two licensed specialists in ADHD (a Clinical Psychologist and a Psychiatrist).
Further to the above, demonstrate that the agreement between the MT1 output and the specialist clinician diagnosis will be non-inferior to the level of agreement between the clinician diagnosis with the Test of Visual Attention (TOVA) FDA cleared device.
- Conditions
- ADHD
- Being tested
- MT1 Auditory startle response patterns analysis algorithm, T.O.V.A. Continuous Performance Test
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT1 Auditory startle response patterns analysis algorithmDevice
Objective measurements of attention and inhibition.
T.O.V.A. Continuous Performance TestDevice
Objective measurements of attention and inhibitory control.
| Study group | Role | What they receive |
|---|---|---|
| ADHD group | Experimental | 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. Receives: Device: MT1 Auditory startle response patterns analysis algorithm; Device: T.O.V.A. Continuous Performance Test |
| Non-ADHD group | Experimental | 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. Receives: Device: MT1 Auditory startle response patterns analysis algorithm; Device: T.O.V.A. Continuous Performance Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The outcome measure will be calculated by using the following formula:
Over All Agreement = (True Positive + True Negative) / (True Positive + True Negative + False Positive + False Negative) X 100.
Measured: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).
Secondary outcomes (4)
Positive Predicted Value (PPV) - conditional probability that the condition will be positive if the test is positive.
The outcome measure will be calculated using the following formula:
Positive Predicted Value = (True Positive) / (True Positive + False Positive) X 100
Measured: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).
Negative Predicted Value (NPV) - conditional probability that the condition will be normal if the test is normal.
The outcome measure will be calculated using the following formula:
Negative Predicted Value = (True Negative) / (True Negative + False Negative) X 100
Measured: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).
Sensitivity - conditional probability that the test will be positive if the condition is positive.
The outcome measure will be calculated using the following formula:
Sensitivity = (True Positive) / (True Positive + False Negative) X 100
Measured: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).
Specificity - conditional probability that the test will be normal if the condition is normal.
The outcome measure will be calculated using the following formula:
Specificity = (True Negative) / (True Negative + False Positive) X 100
Measured: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start2 Jun 2024
- Primary completionJan 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will include a group of subjects who have ADHD and subjects who are healthy controls based on the specialist clinician assessment. Following the specialist clinician assessment each subject will undergo a test using the FDA cleared T.O.V.A and MindTension's MT1.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MindTension
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Newcorn, MD Professor, Principal investigator, Director, Division of ADHD and Learning Disorders Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728969
- Sponsor's protocol ID
- 2023-0000
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study to Evaluate a Novel Algorithm Using Data Derived from a Non-Invasive Digital Biomarker As a Diagnostic Aid for ADHD in Youth Ages 6-17.
- ClinicalTrials.gov ID
- NCT06728969
- Acronym / sponsor ID
- 2023-0000
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- MindTensionIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study aims to demonstrate the accuracy of the MT1 algorithm. The output of the MT1 algorithm will be compared to a Gold Standard clinical diagnosis made by specialist clinician diagnosis supported by the Kiddie SADS Present and Lifetime semi-structured interview (K-SADS-PL) and norm-referenced measures of current ADHD symptom frequency and severity using the ADHD-RS-5 rating scale. Diagnosis will be scaled according to the Diagnostic and Statistical Manual of Mental Disorders- 5 (DSM-5) criteria, and made with agreement between two licensed specialists in ADHD (a Clinical Psychologist and a Psychiatrist).
Further to the above, demonstrate that the agreement between the MT1 output and the specialist clinician diagnosis will be non-inferior to the level of agreement between the clinician diagnosis with the Test of Visual Attention (TOVA) FDA cleared device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will include a group of subjects who have ADHD and subjects who are healthy controls based on the specialist clinician assessment. Following the specialist clinician assessment each subject will undergo a test using the FDA cleared T.O.V.A and MindTension's MT1.
| Arm | Type | Receives |
|---|---|---|
| ADHD group | Experimental | Device: MT1 Auditory startle response patterns analysis algorithm, Device: T.O.V.A. Continuous Performance TestSubjects 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. |
| Non-ADHD group | Experimental | Device: MT1 Auditory startle response patterns analysis algorithm, Device: T.O.V.A. Continuous Performance TestSubjects 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT1 Auditory startle response patterns analysis algorithmObjective measurements of attention and inhibition. | Device | ADHD group, Non-ADHD group |
| T.O.V.A. Continuous Performance TestObjective measurements of attention and inhibitory control. | Device | ADHD group, Non-ADHD group |
Primary outcome
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).
The outcome measure will be calculated by using the following formula: Over All Agreement = (True Positive + True Negative) / (True Positive + True Negative + False Positive + False Negative) X 100.
4 secondary outcomes
Positive Predicted Value (PPV) - conditional probability that the condition will be positive if the test is positive.
Time frame: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).
Negative Predicted Value (NPV) - conditional probability that the condition will be normal if the test is normal.
Time frame: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).
Sensitivity - conditional probability that the test will be positive if the condition is positive.
Time frame: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).
Specificity - conditional probability that the test will be normal if the condition is normal.
Time frame: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Newcorn, MD Professor principal investigator
Director, Division of ADHD and Learning Disorders Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MT1 Auditory startle response patterns analysis algorithm and T.O.V.A. Continuous Performance Test in people with ADHD, run by MindTension at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Newcorn, MD Professor (212-659-8705, jeffrey.newcorn@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.