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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
200
Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control
ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit
Petah Tikva, Israel
RECRUITINGMindtension 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
Time frame: baseline and 1 hour post treatment
ADHD severity
ADHD-RS-IV questionnaire ADHD-RS-IV questionnaire
Time frame: Baseline
Impulsive dysregulation
Clinical Global Impression (CGI): Clinical Global Impression - Severity and Clinical Global Impression - Improvement (CGI-S, CGI-I, respectively)
Time frame: Baseline
CBCL
A questionnaire filled by the parents to describe their children's behavioral and emotional problems, version CBCL/4 to 18
Time frame: Baseline
Changes in treatment
Tolerability, switching rate, changes in formulation is examined using information from electronic medical records three clinical follow-up visits.
Time frame: Baseline
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