The Efficacy of Mindtesionis Measuring Attentional and the Startle Response Dysregulation in Children and Adolescents Suffering From Attention Deficit Disorder: With and Without Medication.

Study Overview
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Brief Summary
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Double blind, placebo-controlled clinical study designed to evaluate Mindtension device and Protocol as a diagnostic tool in children diagnosed with ADHD

Detailed Description
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Mindtension device measures the orbicularis muscle response to auditory stimuli, the device is backed up by an algorithm that calculate the several parameters of startle reflex such as the Paired-pulse inhibition (PPI), Habituation, and startle related indices. Data collected by the device is used to evaluate the subject levels of attention, Hyperarousal and Impulsivity, by means of physiological EMG signals of the startle response. Evaluating baseline differences in these parameters between ADHD and age matched healthy controls, and the possible improvement after psychostimulant medications.

Official Title
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The Efficacy of Mindtesionis Measuring Attentional and the Startle Response Dysregulation in Children and Adolescents Suffering From Attention Deficit Disorder: With and Without Medication.

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Device: MT1 Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (i) Children with ADHD according to DSM-5 criteria in a semi-structured interview by a senior psychiatrist. (ii) Reaching 85 percent score on the ADHD-RS scale. (iii) Treated with a stimulant in the perceived optimal dosage. Exclusion Criteria: (i) autism spectrum disorder. (ii) chronic neurological disorders and chronic medical conditions (e.g., diabetes). (iii) schizophrenia spectrum and other psychotic disorders. (iv) substance abuse (drugs or alcohol). (v) depression. (vi) hearing loss. (vii) lack of cooperation.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPH / AMPH Treatment<br> | Device: MT1 Device<br>* Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control<br>* Other names: Mindtension Attention Algorithm;|
| Placebo Comparator: Placebo<br> | Device: MT1 Device<br>* Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control<br>* Other names: Mindtension Attention Algorithm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mindtension EMG values | startle reflex indices such as the Paired-pulse inhibition (PPI), Habituation, and startle response amplitude, eye-blink probability, amplitude coefficients, inter-trial variability | baseline and 1 hour post treatment | 
| ADHD severity | ADHD-RS-IV questionnaire ADHD-RS-IV questionnaire | Baseline | 
| Impulsive dysregulation | Clinical Global Impression (CGI): Clinical Global Impression - Severity and Clinical Global Impression - Improvement (CGI-S, CGI-I, respectively) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBCL | A questionnaire filled by the parents to describe their children's behavioral and emotional problems, version CBCL/4 to 18 | Baseline | 
| Changes in treatment | Tolerability, switching rate, changes in formulation is examined using information from electronic medical records three clinical follow-up visits. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Attention