NCT05753969

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Geha Mental Health Center · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DEVICE	MT1 Device	Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control

Timeline

• Start date: 2021-02-23
• Primary completion: 2023-12-31
• Completion: 2024-02-28
• First posted: 2023-03-03
• Last updated: 2023-03-03

Locations

1 site across 1 country: Israel