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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05753969

Enrollment

200

Registered

2023-03-03

Start date

2021-02-23

Completion date

2024-02-28

Last updated

2023-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD, Attention

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.

Interventions

DEVICEMT1 Device

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

7 Years to 18 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Israel

Contacts

Primary ContactIris Manor, MD

IManor@clalit.org.il+97239728600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026