Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-17 @ 7:38 AM
Study NCT ID:
NCT02324959
Status:
UNKNOWN
Last Update Posted:
2014-12-24
First Post:
2014-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture and Computer-based Training to Improve Attention Deficits in Patients After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-19', 'studyFirstSubmitDate': '2014-12-08', 'studyFirstSubmitQcDate': '2014-12-19', 'lastUpdatePostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP))', 'timeFrame': 'Pretest (day 1), Posttest (4 weeks)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in time needed for Trail Making Test (TMT A/-B) at four weeks.', 'timeFrame': 'Pretest (day 1), Posttest (4 weeks)'}, {'measure': 'Change from Baseline in number of errors for the Test des Deux Barrage (T2B) at four weeks.', 'timeFrame': 'Pretest (day 1), Posttest (4 weeks)'}, {'measure': 'Change from Baseline in number of omissions for the Test des Deux Barrage (T2B) at four weeks.', 'timeFrame': 'Pretest (day 1), Posttest (4 weeks)'}, {'measure': 'National Institute of Health Stroke Scale (NIH-SS)', 'timeFrame': 'Pretest (day 1)'}, {'measure': 'Change from baseline in total score of Extended Barthel Index (EBI) at four weeks.', 'timeFrame': 'Pretest (day 1), Posttest (4 weeks)'}, {'measure': 'Change from baseline score of EuroQol quality of life questionnaire (EQ-5D 3L) at four weeks.', 'timeFrame': 'Pretest (day 1), Posttest (4 weeks)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '26631161', 'type': 'DERIVED', 'citation': 'Huang J, McCaskey MA, Yang S, Ye H, Tao J, Jiang C, Schuster-Amft C, Balzer C, Ettlin T, Schupp W, Kulke H, Chen L. Effects of acupuncture and computer-assisted cognitive training for post-stroke attention deficits: study protocol for a randomized controlled trial. Trials. 2015 Dec 2;16:546. doi: 10.1186/s13063-015-1054-x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether acupuncture and computer-based attention training can be combined for more effective post-stroke attentional deficits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to inpatient stroke rehabilitation within six months after first-ever stroke\n* Mild cognitive impairments (attention performance TAP \\> 1 standard deviation below mean age-matched norm in at least one subtest).\n* Conscious, stable physical condition and signed informed consent of patient.\n\nExclusion Criteria:\n\n* Severe visual and/or hearing problems\n* Inability to follow instructions (MoCA)\n* Disorders of speech and instruction comprehension (tested with a modified token-test)\n* Severe visual and/or hearing problems\n* Pre-existing mental disorders - Pregnancy'}, 'identificationModule': {'nctId': 'NCT02324959', 'acronym': 'ACoTrain', 'briefTitle': 'Acupuncture and Computer-based Training to Improve Attention Deficits in Patients After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Fujian University of Traditional Chinese Medicine'}, 'officialTitle': 'Evaluation of Acupuncture and Attention Training Effects on Patients After Stroke: a Study Protocol of an International Multicentre Study Using a Randomized Single Blinded Three-group Design', 'orgStudyIdInfo': {'id': '651'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acupuncture', 'description': 'Needling of affected meridian groups in line with Traditional Chinese Medicine procedures (Baihui and Shenting).', 'interventionNames': ['Device: Acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Computer-based', 'description': 'Computer-based attention training (RehaCom).', 'interventionNames': ['Device: RehaCom']}, {'type': 'EXPERIMENTAL', 'label': 'ACoTrain', 'description': 'A combination of computer-based attention training with acupuncture.', 'interventionNames': ['Device: RehaCom', 'Device: Acupuncture']}], 'interventions': [{'name': 'RehaCom', 'type': 'DEVICE', 'otherNames': ['computer-based attention training'], 'description': 'The computer-based neurorehabilitation program is intended for patients with acquired cognitive deficits after brain damage, e.g. after stroke. The RehaCom software has five different therapeutic groups aimed at restoration of attention, memory, executive functions, and visual field, respectively. Each group has one to four different modules to choose from for each therapy session. Only attention will be trained in this study.', 'armGroupLabels': ['ACoTrain', 'Computer-based']}, {'name': 'Acupuncture', 'type': 'DEVICE', 'description': 'The affected meridian group is treated by needling on Baihui (GV20\\|DU20) and Shenting (GV24\\|DU24) - both acupoints of the Governor Vessel. Baihui is 5 cun (1cun=3.33 cm) superior to the anterior hairline on the anterior median line (midpoint of the connecting line between the auricular apices).', 'armGroupLabels': ['ACoTrain', 'Acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350003', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shanli Yang, Dr. Med.', 'role': 'CONTACT', 'email': '49688400@qq.com', 'phone': '+8613705949762'}, {'name': 'Su Youxin, Dr. Med.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shi Haibin, Dr. Med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fujian University of Traditional Chinese Medicine', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '91074', 'city': 'Herzogenaurach', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Wilfried Schupp, Dr. med.', 'role': 'CONTACT', 'email': 'wilfried.schupp@fachklinik-herzogenaurach.de', 'phone': '+419132831035'}, {'name': 'Hartwig Kulke, Ph.D.', 'role': 'CONTACT'}, {'name': 'Jia Huang, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Natalia Madrigal, Dr. med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'm&i Fachklinik Herzogenaurach', 'geoPoint': {'lat': 49.56798, 'lon': 10.88565}}, {'zip': '4310', 'city': 'Rheinfelden', 'state': 'Canton of Aargau', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Michael A. McCaskey, MSc.', 'role': 'CONTACT', 'email': 'm.mccaskey@reha-rhf.ch', 'phone': '+41618365383'}, {'name': 'Corina Schuster-Amft, PhD PT', 'role': 'CONTACT', 'email': 'c.schuster@reha-rhf.ch', 'phone': '+41618365381'}, {'name': 'Zorica Suica, MSc. PT', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Reha Rheinfelden', 'geoPoint': {'lat': 47.55437, 'lon': 7.79403}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Reha Rheinfelden', 'class': 'OTHER'}, {'name': 'm&i-Fachklinik Herzogenaurach', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Shanli Yang', 'investigatorAffiliation': 'Fujian University of Traditional Chinese Medicine'}}}}