Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT05308706
Status:
UNKNOWN
Last Update Posted:
2022-04-04
First Post:
2022-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of the Apollo System for Children With ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D007266', 'term': 'Inhibition, Psychological'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-19', 'size': 62290, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-23T11:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blind, sham/placebo controlled trial.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All participants receive an Apollo System device. However, participants are randomly assigned to receive a device that uses the current pattern of vibrations as in the commercial Apollo System device or receive a device that uses an ultra-low frequency pattern of vibrations (sham device).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2022-03-24', 'studyFirstSubmitQcDate': '2022-03-24', 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ADHD symptomatology as assessed using the ADHD-5 Rating Scale', 'timeFrame': 'Prior to and following the 8 week study protocol period.', 'description': 'At pre and posttest, the parents/guardians of participants will complete the ADHD-5 Rating Scale. The behaviors included in the survey are derived from the diagnostic criteria for ADHD established in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition. Scores are summated into inattentive and hyperactive-impulsive symptom domains and transformed into symptom percentile scores based upon normative data based on age and biological sex. Change in the overall ADHD percentile will be considered as the primary outcome. A more negative change would indicate a better outcome reflective of reduction in ADHD related symptomatology.'}, {'measure': 'Effect Size for Change in Behavioral Index of Interference Control', 'timeFrame': 'Prior to and following the 8 week study protocol period.', 'description': "At pre and posttest, participants will complete a version of the Eriksen flanker task. Response accuracy will be quantified within each congruency as the proportion of correct responses relative to the number of trials administered. The effect size of the change from pre-to-posttest in overall response accuracy will be considered as the primary outcome.\n\nEffect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013)."}, {'measure': 'Effect Size for Change in Behavioral Index of Response Inhibition', 'timeFrame': 'Prior to and following the 8 week study protocol period.', 'description': "At pre and posttest, participants will complete a version of the go/nogo task. Response accuracy will be quantified as the proportion of correct responses relative to the number of trials administered for target stimulus trails and nogo stimulus trials separately. The effect size of the change from pre-to-posttest for response accuracy to the nogo condition will be considered as the primary outcome.\n\nEffect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013)."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ADHD', 'Inhibition', 'Vibrational therapy'], 'conditions': ['Attention Deficit Disorder With Hyperactivity']}, 'descriptionModule': {'briefSummary': 'To determine the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.', 'detailedDescription': 'The objective of this project is to understand the potential therapeutic benefits of the Apollo System for children with ADHD. Using vibrational therapy, the Apollo System has been previously demonstrated to promote greater balance of the autonomic nervous system. Given the importance of the autonomic nervous system for modulating levels of physiological arousal and in-turn governing aspects of attention and self-regulation; a therapeutic approach to promote better balance of this system may be particularly beneficial for populations such as children with ADHD. Accordingly, using a double-blind randomized placebo-controlled design this investigation will assess the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: All individuals that agreed to participate will be selected on a first come, first serve basis. No individual will be turned down due to sex, race, or ethnicity. The following inclusion criteria exist for all participants:\n\n1. Participants must be 8 years of age or older and under the age of 18.\n2. Participants must have diagnosed or suspected Attention Deficit Hyperactivity Disorder (ADHD).\n3. Participants must have one of the following: 1) on the same treatment plan for over a year with minimal symptom relieve or alleviation, 2) tried two or more treatment approaches but is unable to meet treatment goals, 3) taking medication but still has symptoms, or 4) unwanted or uncontrollable side effects related to the medication.\n4. Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.\n\nExclusion Criteria: The following exclusion criteria exist for all participants:\n\n1. Lack of consent.\n2. Participants cannot have started a new treatment within the last 30 days.\n3. Participants cannot have a history of hydrocephalus, Autism Spectrum Disorder, Schizophrenia, Conduct disorder, Oppositional Defiant Disorder, active substance abuse, or be on a beta blocker.\n4. Participants cannot have previously used the Apollo System.'}, 'identificationModule': {'nctId': 'NCT05308706', 'briefTitle': 'Efficacy of the Apollo System for Children With ADHD', 'organization': {'class': 'OTHER', 'fullName': 'Michigan State University'}, 'officialTitle': 'Double-blind Randomized Placebo-controlled Trial of the Efficacy of the Apollo System for Children With ADHD', 'orgStudyIdInfo': {'id': 'STUDY00005951'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Commercial Apollo System Device', 'description': 'The active experimental group received the commercial Apollo System device.', 'interventionNames': ['Device: 8 weeks of home based use.']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Apollo System Device', 'description': 'The control experimental group received a sham/placebo device that is identical to the commercial Apollo System device but uses an ultra-low (i.e., effectively zero) frequency pattern of vibrations.', 'interventionNames': ['Device: 8 weeks of home based use.']}], 'interventions': [{'name': '8 weeks of home based use.', 'type': 'DEVICE', 'description': 'Use of the devices for an 8 week study period. Devices are preset to follow a scheduled activation pattern during the day.', 'armGroupLabels': ['Commercial Apollo System Device', 'Sham Apollo System Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew B Pontifex, Ph.D.', 'role': 'CONTACT', 'email': 'pontifex@msu.edu', 'phone': '517-432-5105'}, {'name': 'Matthew B Pontifex, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Kinesiology', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}], 'centralContacts': [{'name': 'Matthew B Pontifex, PhD', 'role': 'CONTACT', 'email': 'pontifex@msu.edu', 'phone': '517-432-5105'}], 'overallOfficials': [{'name': 'Matthew B Pontifex, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan State University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available following primary publication of the results.', 'ipdSharing': 'YES', 'description': 'Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.', 'accessCriteria': 'By request and completion of an institutional data-safety and sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michigan State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Board of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Matthew B. Pontifex, Ph.D.', 'investigatorAffiliation': 'Michigan State University'}}}}