Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-01 @ 10:24 PM
Study NCT ID:
NCT05753969
Status:
UNKNOWN
Last Update Posted:
2023-03-03
First Post:
2023-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2023-02-23', 'studyFirstSubmitQcDate': '2023-02-23', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mindtension EMG values', 'timeFrame': 'baseline and 1 hour post treatment', 'description': 'startle reflex indices such as the Paired-pulse inhibition (PPI), Habituation, and startle response amplitude, eye-blink probability, amplitude coefficients, inter-trial variability'}, {'measure': 'ADHD severity', 'timeFrame': 'Baseline', 'description': 'ADHD-RS-IV questionnaire ADHD-RS-IV questionnaire'}, {'measure': 'Impulsive dysregulation', 'timeFrame': 'Baseline', 'description': 'Clinical Global Impression (CGI): Clinical Global Impression - Severity and Clinical Global Impression - Improvement (CGI-S, CGI-I, respectively)'}], 'secondaryOutcomes': [{'measure': 'CBCL', 'timeFrame': 'Baseline', 'description': "A questionnaire filled by the parents to describe their children's behavioral and emotional problems, version CBCL/4 to 18"}, {'measure': 'Changes in treatment', 'timeFrame': 'Baseline', 'description': 'Tolerability, switching rate, changes in formulation is examined using information from electronic medical records three clinical follow-up visits.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADHD', 'Attention'], 'conditions': ['Attention Deficit Disorder With Hyperactivity']}, 'descriptionModule': {'briefSummary': 'Double blind, placebo-controlled clinical study designed to evaluate Mindtension device and Protocol as a diagnostic tool in children diagnosed with ADHD', 'detailedDescription': '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.\n\nData 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.\n\nEvaluating baseline differences in these parameters between ADHD and age matched healthy controls, and the possible improvement after psychostimulant medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(i) Children with ADHD according to DSM-5 criteria in a semi-structured interview by a senior psychiatrist.\n\n(ii) Reaching 85 percent score on the ADHD-RS scale. (iii) Treated with a stimulant in the perceived optimal dosage.\n\nExclusion Criteria:\n\n(i) autism spectrum disorder. (ii) chronic neurological disorders and chronic medical conditions (e.g., diabetes).\n\n(iii) schizophrenia spectrum and other psychotic disorders. (iv) substance abuse (drugs or alcohol). (v) depression. (vi) hearing loss. (vii) lack of cooperation.'}, 'identificationModule': {'nctId': 'NCT05753969', 'briefTitle': '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.', 'organization': {'class': 'OTHER', 'fullName': 'Geha Mental Health Center'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '01-20-GEH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MPH / AMPH Treatment', 'interventionNames': ['Device: MT1 Device']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Device: MT1 Device']}], 'interventions': [{'name': 'MT1 Device', 'type': 'DEVICE', 'otherNames': ['Mindtension Attention Algorithm'], 'description': 'Pre-and post-evaluation in MT1 device following stimulant treatment or placebo control', 'armGroupLabels': ['MPH / AMPH Treatment', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4954040', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Iris Manor, MD', 'role': 'CONTACT', 'email': 'IManor@clalit.org.il', 'phone': '+972-3-972-8600'}], 'facility': 'ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Iris Manor, MD', 'role': 'CONTACT', 'email': 'IManor@clalit.org.il', 'phone': '+97239728600'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geha Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of ADHD clinic, Dan Petach-Tiqva, Geha MHC, Clalit', 'investigatorFullName': 'Iris Manor', 'investigatorAffiliation': 'Geha Mental Health Center'}}}}