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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.

Sponsor
Geha Mental Health Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05753969
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
36.1
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: MT1 Device
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
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.
Actual Study Start Date :
Feb 23, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    Placebo Comparator: Placebo

    Device: MT1 Device
    Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control
    Other Names:
  • Mindtension Attention Algorithm

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. ADHD severity [Baseline]

      ADHD-RS-IV questionnaire ADHD-RS-IV questionnaire

    3. Impulsive dysregulation [Baseline]

      Clinical Global Impression (CGI): Clinical Global Impression - Severity and Clinical Global Impression - Improvement (CGI-S, CGI-I, respectively)

    Secondary Outcome Measures

    1. CBCL [Baseline]

      A questionnaire filled by the parents to describe their children's behavioral and emotional problems, version CBCL/4 to 18

    2. Changes in treatment [Baseline]

      Tolerability, switching rate, changes in formulation is examined using information from electronic medical records three clinical follow-up visits.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit Petah Tikwah Israel 4954040

    Sponsors and Collaborators

    • Geha Mental Health Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Iris Manor, Director of ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit, Geha Mental Health Center
    ClinicalTrials.gov Identifier:
    NCT05753969
    Other Study ID Numbers:
    • 01-20-GEH
    First Posted:
    Mar 3, 2023
    Last Update Posted:
    Mar 3, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Iris Manor, Director of ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit, Geha Mental Health Center
    ADHD
    Attention
    Additional relevant MeSH terms:
    Attention Deficit Disorder with Hyperactivity

    Study Results

    No Results Posted as of Mar 3, 2023