Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
Study NCT ID:
NCT04526600
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2020-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fidgeting and Attentional and Emotional Regulation in ADHD
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': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 109}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Processing speed', 'timeFrame': 'Day 1', 'description': 'Paced Auditory Serial Addition Task (PASAT)'}, {'measure': 'Working memory', 'timeFrame': 'Day 1', 'description': 'List Sorting Test'}, {'measure': 'Response inhibition', 'timeFrame': 'Day 1', 'description': 'Flanker type test'}], 'secondaryOutcomes': [{'measure': 'Physiological response as an index of emotional regulation', 'timeFrame': 'Approximately 45 minutes', 'description': 'Heart rate variability and pre ejection period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ADHD']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://studypages.com/s/can-fidgeting-lead-to-enhanced-attention-and-emotional-regulation-in-adhd-449990/', 'label': 'Learn more or sign up for the study here!'}]}, 'descriptionModule': {'briefSummary': 'This project will study how fidgeting relates to cognitive and emotional functioning in adults with attention-deficit/hyperactivity disorder (ADHD). It will determine, in a laboratory setting, whether movement and access to a "fidget device" providing sensory and motor stimulation can improve cognitive and emotional regulation (including on physiological measures) in adult ADHD. The investigators will also acquire pilot data for machine learning analyses to be used in future, large scale studies to identify gestures and touch characteristics associated with improved cognitive and emotional regulation to see if the data can predict and subsequently develop recommendations to improve performance and emotional control in natural settings (e.g., home, office, college classroom) for adult ADHD.', 'detailedDescription': "Fidgeting is a highly common behavior, with excessive fidgeting associated with attention-deficit/hyperactivity disorder (ADHD). Studies from the investigator's laboratory and colleagues suggest physical movement can enhance cognitive performance in children with ADHD. Hyper-sensorimotor behavior may be related to impaired regulation of arousal in the noradrenergic and dopaminergic systems. This project will assess if frequency and characteristics of sensorimotor behavior relates to cognitive and emotional response in adults with ADHD, in a fine-grained manner, unlike other studies. The investigators will test if intrinsic fidgeting (Aim 1) and access to a specially designed fidget device (Aim 2) modulates behavioral and physiological response in cognitively and emotionally-demanding contexts. The hype of the commercially available fidget devices, its competitors and fidget spinners suggest it might, but there is no systematic evidence to inform consumers, a gap, the investigators aim to fill."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ADHD\n* History of fidgeting\n\nExclusion Criteria:\n\n* Currently taking psychoactive medication, with the exception of stimulant medication for ADHD or medication that can affect heart rate;\n* Presence of significant depression or psychotic disorders, autism, visual or hearing impairment or any other disorder that may interfere with task performance; and IQ below 85'}, 'identificationModule': {'nctId': 'NCT04526600', 'briefTitle': 'Fidgeting and Attentional and Emotional Regulation in ADHD', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Can Fidgeting Lead to Enhanced Attention and Emotional Regulation in ADHD?', 'orgStudyIdInfo': {'id': '1607722'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No fidget'}, {'type': 'EXPERIMENTAL', 'label': 'With fidget', 'description': 'The participant is given a specially designed fidget ball', 'interventionNames': ['Other: Fidget ball']}], 'interventions': [{'name': 'Fidget ball', 'type': 'OTHER', 'description': "Access to a prototype 'smart' fidget ball with pressure sensors embedded, that produces touch traces and transmits real time data", 'armGroupLabels': ['With fidget']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jared Borden', 'role': 'CONTACT', 'email': 'jborden@ucdavis.edu', 'phone': '916-703-0294'}], 'facility': 'UC Davis MIND Institute', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'centralContacts': [{'name': 'Jared Borden', 'role': 'CONTACT', 'email': 'jborden@ucdavis.edu', 'phone': '916-703-0294'}], 'overallOfficials': [{'name': 'Julie Schweitzer, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis MIND Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Undecided, likely after publication date', 'ipdSharing': 'YES', 'description': 'Data will be shared via NDAR', 'accessCriteria': 'Will be through NDAR'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}