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.

February 23, 2023 updated by: Iris Manor, Geha Mental Health Center
Double blind, placebo-controlled clinical study designed to evaluate Mindtension device and Protocol as a diagnostic tool in children diagnosed with ADHD

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Petah Tikwah, Israel, 4954040
        • Recruiting
        • ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Device: MT1 Device
Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control
Other Names:
  • Mindtension Attention Algorithm
Experimental: MPH / AMPH Treatment
Device: MT1 Device
Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control
Other Names:
  • Mindtension Attention Algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mindtension EMG values
Time Frame: 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
baseline and 1 hour post treatment
ADHD severity
Time Frame: Baseline
ADHD-RS-IV questionnaire ADHD-RS-IV questionnaire
Baseline
Impulsive dysregulation
Time Frame: Baseline
Clinical Global Impression (CGI): Clinical Global Impression - Severity and Clinical Global Impression - Improvement (CGI-S, CGI-I, respectively)
Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geha Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

February 28, 2024

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-20-GEH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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