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.

NCT ID: NCT05753969

Last Updated: 2023-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-23

Study Completion Date

2024-02-28

Brief Summary

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

Detailed Description

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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

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MPH / AMPH Treatment

Group Type EXPERIMENTAL

MT1 Device

Intervention Type DEVICE

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

Placebo

Group Type PLACEBO_COMPARATOR

MT1 Device

Intervention Type DEVICE

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

Interventions

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MT1 Device

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

Intervention Type DEVICE

Other Intervention Names

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Mindtension Attention Algorithm

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Geha Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Iris Manor

Director of ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Iris Manor, MD

Role: CONTACT

+97239728600

Facility Contacts

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Iris Manor, MD

Role: primary

+972-3-972-8600

Other Identifiers

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01-20-GEH

Identifier Type: -

Identifier Source: org_study_id

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