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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPH / AMPH Treatment | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT1 Device | Device | Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control |
|
| 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 |
| 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. |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iris Manor, MD | Contact | +97239728600 | IManor@clalit.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit | Recruiting | Petah Tikva | 4954040 | Israel |
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| Baseline |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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