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.

Not Applicable

Recruiting

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Device: MT1 Device

• Registration Number: NCT05753969
• Lead Sponsor: Geha Mental Health Center

Brief 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.

Study Timeline

• Study Start: 2021-02-23
• Status Verified: 2023-02
• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-02-23
• Last Update Submitted: 2023-02-23
• Study First Posted: 2023-03-03
• Last Update Posted: 2023-03-03
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	MT1 Device	-
MPH / AMPH Treatment	MT1 Device	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit; 🇮🇱 Petah Tikwah, Israel