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
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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UNKNOWN
NA
200 participants
INTERVENTIONAL
2021-02-23
2024-02-28
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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MPH / AMPH Treatment
MT1 Device
Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control
Placebo
MT1 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
(ii) Reaching 85 percent score on the ADHD-RS scale. (iii) Treated with a stimulant in the perceived optimal dosage.
Exclusion Criteria
(iii) schizophrenia spectrum and other psychotic disorders. (iv) substance abuse (drugs or alcohol). (v) depression. (vi) hearing loss. (vii) lack of cooperation.
7 Years
18 Years
ALL
Yes
Sponsors
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Geha Mental Health Center
OTHER
Responsible Party
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Iris Manor
Director of ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit
Locations
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ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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01-20-GEH
Identifier Type: -
Identifier Source: org_study_id
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