Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-04 @ 10:57 AM
Study NCT ID:
NCT02688959
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2016-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Attention Training for Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026302', 'term': 'Tai Ji'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 145}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2016-02-18', 'studyFirstSubmitQcDate': '2016-02-22', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in symptoms of inattention', 'timeFrame': '8 weeks', 'description': 'Inattentive Symptoms subscale of the Conners Adult ADHD Rating Scale self-report long form (CAARS-S:L). The total range of scores is 0-27 with higher scores indicating more severe symptom levels.'}], 'secondaryOutcomes': [{'measure': 'Feasibility of implementing wireless Electroencephalogram(EEG) to measure the theta beta ratio during performance of tai chi.', 'timeFrame': 'up to 90 minute', 'description': 'Feasibility of implementing wireless EEG will be assessed by the quality of EEG data. Acceptable data should have satisfactory signal to noise characteristics. Satisfactory signal to noise ratio will be evaluated by the variance within individual across trials of the ratio of occipital alpha power between the eyes closed and eyes open conditions. Feasibility will be judged by the criterion that the coefficient of variance (CV = s.d./mean) be less than 1/3.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['motor attention training', 'exercise', 'tai chi', 'ADHD'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '24478679', 'type': 'BACKGROUND', 'citation': 'Converse AK, Ahlers EO, Travers BG, Davidson RJ. Tai chi training reduces self-report of inattention in healthy young adults. Front Hum Neurosci. 2014 Jan 27;8:13. doi: 10.3389/fnhum.2014.00013. eCollection 2014.'}, {'pmid': '33066865', 'type': 'RESULT', 'citation': 'Converse AK, Barrett BP, Chewning BA, Wayne PM. Tai Chi training for attention deficit hyperactivity disorder: A feasibility trial in college students. Complement Ther Med. 2020 Sep;53:102538. doi: 10.1016/j.ctim.2020.102538. Epub 2020 Aug 14.'}], 'seeAlsoLinks': [{'url': 'http://brainimaging.waisman.wisc.edu/~converse/', 'label': 'Converse personal site'}]}, 'descriptionModule': {'briefSummary': 'The investigators will perform a feasibility/pilot trial of two non-pharmacological interventions for ADHD in college students.', 'detailedDescription': 'College students diagnosed with ADHD will be randomized to three arms of approximately 8 weeks duration: (1) standard care plus a tai chi class, (2) standard care plus an exercise class, and (3) standard care alone. The exercise class will control for the social and motor components of tai chi training. The investigators will determine methodological parameters relevant to a subsequent full scale trial including recruitment and retention rates, acceptance of randomization, adherence to the interventions, and variance in outcome measures. The primary clinical outcome measure of this pilot randomized controlled trial (RCT) will be pre- to post-intervention change in inattention, i.e. the Inattentive Symptoms subscale of the Conners Adult ADHD Rating Scale self-report long form (CAARS-S:L, see Interviews etc. "Converse\\_S\\_L"). Secondary measures to be explored will include self- and informant-report, neurocognitive measures, psychophysiological measures, and academic performance. Practice time will be assessed daily and follow-up self-report of ADHD symptoms will be gathered monthly for 3 months beyond the end of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '23 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* University of Wisconsin-Madison enrolled undergraduate\n* Documented ADHD diagnosis\n\nExclusion Criteria:\n\n* Unable or unwilling to participate in the interventions'}, 'identificationModule': {'nctId': 'NCT02688959', 'briefTitle': 'Motor Attention Training for Attention Deficit Hyperactivity Disorder (ADHD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'A Feasibility/Pilot Trial of a Motor Attention Training Intervention for College Students With ADHD', 'orgStudyIdInfo': {'id': '2015-0807'}, 'secondaryIdInfos': [{'id': 'A348700', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'VCRGE\\WAISMAN CENTER\\WAISMAN', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol version 15 July 2024', 'type': 'OTHER', 'domain': 'IRB UW, Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tai Chi', 'description': 'Participants in this arm will attend 50-minute classes 2 times per week for 8 weeks. The course will emphasize experiential learning with 2 weeks of introductory sessions on gait, posture, and tai chi principles followed by instruction in the 24-form Yang style sequence. Students will be given a video to aid learning outside of class, and maintenance of practice post-intervention.', 'interventionNames': ['Behavioral: Tai Chi']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise', 'description': 'Participants in the exercise arm will attend 50-minute classes 2 times per week for 8 weeks. The course will emphasize cardio-aerobic fitness training. Students will be given a video to aid practice outside of class, and maintenance of practice post-intervention.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in the control arm will not attend a class and not be given a video.'}], 'interventions': [{'name': 'Tai Chi', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Tai Chi']}, {'name': 'Exercise', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander K Converse, PhD', 'role': 'CONTACT', 'email': 'adhd@bi.wisc.edu', 'phone': '608-265-6604'}], 'facility': 'University of Wisconsin-Madison, Waisman Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Alexander K Converse, PhD', 'role': 'CONTACT', 'email': 'adhd@bi.wisc.edu', 'phone': '608 265 6604'}], 'overallOfficials': [{'name': 'Alexander K Converse, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}