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.

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753969
• Other study ID #: 01-20-GEH
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2023
• Source: Geha Mental Health Center
• Contact: Iris Manor, MD
• Phone: +97239728600
• Email: IManor[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity

Intervention

Device:
• MT1 Device
Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control

Locations

Country	Name	City	State
Israel	ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit	Petah Tikwah

Sponsors (1)

Lead Sponsor	Collaborator
Geha Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	ADHD severity	ADHD-RS-IV questionnaire ADHD-RS-IV questionnaire	Baseline
Primary	Impulsive dysregulation	Clinical Global Impression (CGI): Clinical Global Impression - Severity and Clinical Global Impression - Improvement (CGI-S, CGI-I, respectively)	Baseline
Secondary	CBCL	A questionnaire filled by the parents to describe their children's behavioral and emotional problems, version CBCL/4 to 18	Baseline
Secondary	Changes in treatment	Tolerability, switching rate, changes in formulation is examined using information from electronic medical records three clinical follow-up visits.	Baseline