Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-28 @ 6:41 PM
Study NCT ID:
NCT01112761
Status:
TERMINATED
Last Update Posted:
2020-04-24
First Post:
2010-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cortical Plasticity Assessment in Athletes With a History of Concussion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Lack of resources to run the trial', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-23', 'studyFirstSubmitDate': '2010-04-20', 'studyFirstSubmitQcDate': '2010-04-27', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortical excitability and cortical plasticity assessment', 'timeFrame': 'Baseline, 1st, 2nd and 3rd week', 'description': 'TMS and tDCS'}], 'secondaryOutcomes': [{'measure': 'Cognitive functioning in athletes with concussion compared to athletes without concussion', 'timeFrame': 'Baseline, 1st, 2nd and 3rd week', 'description': 'Will use the Immediate Postconcussion Assessment and Cognitive Test (IMPACT): a neuropsychological test battery that measures aspects of cognitive functioning including attention, memory, reaction time and information processing speed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Athletes', 'Multiple Concussions', 'Transcranial Stimulation'], 'conditions': ['Concussion']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to determine whether athletes with concussion have changes in cortical excitability.\n\nSingle and paired transcranial magnetic stimulation (TMS) can be used as reliable neurophysiological marker of motor cortex reorganization in athletes with concussions.\n\nThis study also aims to determine whether modulation of cortical activity by a powerful technique of noninvasive brain stimulation (tDCS) results in a different cortical response as compared with sham tDCS.', 'detailedDescription': 'This study is a multicenter study with investigators from other institutions (Dr. Alvaro Pascual-Leone and Dr. Hugo Theoret).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Student-athletes at risk for traumatic brain injury (collegiate football, ice hockey)\n* Age between 18 and 30 yr.\n* Concussion as defined by the American Academy of Neurology: trauma-induced alteration in mental status that may or may not involve loss of consciousness (confusion and amnesia are the hallmarks of concussion)\n* Concussion that occurred \\> 6 months\n* All head injuries classified as minor with a Glasgow Coma Scale of 13 to 15 at the time of the trauma\n* Participants are cleared for full sport participation based upon neurological and neuropsychological (NS) assessments Classified as symptomatic based on Post-concussion Symptom List\n\nExclusion Criteria:\n\n* Previous significant neurological history\n* Use of tricyclic anti-depressants such as amitriptyline, nortriptyline and imipramine within the past six months.\n* Use of anticonvulsants such as carbamazepine, phenytoin, valproic acid and gabapentin within the past six months\n* History of seizures, depression or PTSD\n* Presence of post-concussion symptoms such as complaints of loss of concentration, dizziness, fatigue, headache, irritability, visual disturbances, and light sensitivity.\n* Contraindications to single pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants\n* history of seizures\n* unexplained loss of consciousness\n* metal in the head\n* frequent or severe headaches or neck pain\n* implanted brain medical devices.\n* Contraindications to tDCS:\n* metal in the head\n* implanted brain medical devices\n\nFor the control group (subjects with no concussion) we will select subjects according to the previously stated list of exclusions as well as the following criteria: Subjects who are athletes (similar to the concussed group) with the same age range and also similar level of education; however these subjects will have no prior history of concussion or neurological insult as self reported. They should also have no contraindications to TMS or tDCS.'}, 'identificationModule': {'nctId': 'NCT01112761', 'briefTitle': 'Cortical Plasticity Assessment in Athletes With a History of Concussion', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'Cortical Plasticity Assessment in Athletes With a History of Concussion', 'orgStudyIdInfo': {'id': '2010P000191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Subjects', 'description': 'Each subject will undergo each of the three conditions (active anodal tDCS, cathodal tDCS and sham tDCS), but the order in which they do so will be randomized.', 'interventionNames': ['Device: Transcranial direct current stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Athletes with history of concussion', 'description': 'Each subject will undergo each of the three conditions (active anodal tDCS, cathodal tDCS and sham tDCS), but the order in which they do so will be randomized.', 'interventionNames': ['Device: Transcranial direct current stimulation']}], 'interventions': [{'name': 'Transcranial direct current stimulation', 'type': 'DEVICE', 'description': 'Each type of stimulation will be administered with a time interval of a week in between to prevent any carryover affects.', 'armGroupLabels': ['Athletes with history of concussion', 'Healthy Subjects']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Felipe Fregni, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spaulding Rehabilitation Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Felipe Fregni', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}