Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
Study NCT ID:
NCT03417492
Status:
TERMINATED
Last Update Posted:
2022-09-21
First Post:
2017-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cerebrovascular Reactivity in American Football Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D038223', 'term': 'Post-Concussion Syndrome'}, {'id': 'D006935', 'term': 'Hypercapnia'}], 'ancestors': [{'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': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label, non-placebo controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Difficulty enrolling participants due to COVID emergency, and planned start of new study to address this question in a more rigorous fashion.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2017-10-11', 'studyFirstSubmitQcDate': '2018-01-24', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effect of 5 weeks sildenafil treatment on CVR as measured by BOLD response to hypercapnia.', 'timeFrame': '5 weeks', 'description': 'To evaluate the effects of 5 weeks of treatment on CVR by measuring BOLD signal in response to hypercapnia after 5 week treatment with sildenafil, compared to within-subject CVR response before sildenafil treatment.'}, {'measure': 'Effect of 5 weeks sildenafil treatment on CVR as measured by fNIRS response to hypercapnia.', 'timeFrame': '5 weeks', 'description': 'To evaluate the effects of 5 weeks of treatment on CVR by measuring fNIRS signal in response to hypercapnia after 5 week treatment with sildenafil, compared to within-subject CVR response before sildenafil treatment.'}, {'measure': 'Effect of 5 weeks of sildenafil treatment on attention using Trail Making Test Part A.', 'timeFrame': '5 weeks', 'description': 'To evaluate the effects of 5 weeks of treatment with sildenafil citrate on attention, measured using the Trail Making Test Part A.'}, {'measure': 'Effect of 5 weeks of sildenafil treatment on attention using the Digit Symbol Modalities Test.', 'timeFrame': '5 weeks', 'description': 'To evaluate the effects of 5 weeks of treatment with sildenafil citrate on attention, measured using the Digit Symbol Modalities Test.'}, {'measure': 'Effect of 5 weeks of sildenafil treatment on executive function using the Trail Making Test Part B.', 'timeFrame': '5 weeks', 'description': 'To evaluate the effects of 5 weeks of treatment with sildenafil citrate on executive function, measured using the Trail Making Test Part B.'}, {'measure': 'Effect of 5 weeks of sildenafil treatment on executive function using the Neuropsychological Assessment Battery (NAB) mazes.', 'timeFrame': '5 weeks', 'description': 'To evaluate the effects of 5 weeks of treatment with sildenafil citrate on executive function, measured using the Neuropsychological Assessment Battery (NAB) mazes.'}, {'measure': 'Effect of 5 weeks of sildenafil treatment on executive function using the Controlled Oral Word Association Test (COWAT).', 'timeFrame': '5 weeks', 'description': 'To evaluate the effects of 5 weeks of treatment with sildenafil citrate on executive function, measured using the Controlled Oral Word Association Test (COWAT).'}, {'measure': 'Effect of 5 weeks of sildenafil treatment on language and memory using the Animal Fluency test.', 'timeFrame': '5 weeks', 'description': 'To evaluate the effects of 5 weeks of treatment with sildenafil citrate on language and memory, measured using the Animal Fluency test.'}, {'measure': 'Effect of 5 weeks of sildenafil treatment on language and memory using the NAB List Learning test.', 'timeFrame': '5 weeks', 'description': 'To evaluate the effects of 5 weeks of treatment with sildenafil citrate on language and memory, measured using the NAB List Learning test.'}, {'measure': 'Effect of 5 weeks of sildenafil treatment on daily function using the Functional Activities Questionnaire.', 'timeFrame': '5 weeks', 'description': 'To evaluate the effects of 5 weeks of treatment with sildenafil citrate on daily function, measured using the Functional Activities Questionnaire. The questionnaire requires the subject to rate the level of difficulty/dependency of each task listed (rating range from 0-3). A lower score indicates less difficulty in the listed activities while a higher score indicates more difficulty. The ratings are summed and the total score is reported (range 0-30).'}], 'primaryOutcomes': [{'measure': 'Effect of single dose sildenafil citrate treatment on global blood oxygen level-dependent (BOLD) response to hypercapnia.', 'timeFrame': 'Immediate', 'description': 'Determine if single dose treatment with sildenafil (60 mg orally) is effective in increasing the global BOLD response to hypercapnia (5% CO2).'}], 'secondaryOutcomes': [{'measure': 'Effect of single dose sildenafil citrate treatment on functional near-infrared spectroscopy (fNIRS) response to hypercapnia.', 'timeFrame': 'Immediate', 'description': 'Determine if single dose treatment with sildenafil (60 mg orally) is effective in increasing the functional near-infrared spectroscopy (fNIRS) response to hypercapnia (5% CO2).'}, {'measure': 'Maximum tolerable dose of sildenafil therapy without severe adverse events.', 'timeFrame': '5 weeks', 'description': 'The number of participants reporting treatment-related adverse events (AEs) and serious adverse events (SAEs) will be monitored after each dose increase. AEs and SAEs are assessed using CTCAE, v4.0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TBI', 'CVR', 'Hypercapnia', 'fNIRS', 'functional magnetic resonance imaging (fMRI)', 'American football'], 'conditions': ['Traumatic Brain Injury', 'Mild Traumatic Brain Injury', 'Post-Concussion Syndrome']}, 'descriptionModule': {'briefSummary': 'Investigators will measure cerebrovascular reactivity (CVR) using functional near-infrared spectroscopy (fNIRS) and magnetic resonance imaging (MRI) during the chronic phase after repetitive mild traumatic brain injury (rmTBI) as a biomarker of traumatic cerebrovascular injury (TCVI). We hypothesize that CVR will be decreased in patients with rmTBI and that these decreases will correlate with clinical outcomes. Furthermore, we predict that 5 week administration of a phosphodiesterase 5 (PDE5) inhibitor, sildenafil citrate, will augment CVR in patients with a history rmTBI.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 40-65 years\n2. Former National Football League (NFL) players or former varsity college football players\n3. Ability to undergo MRI scanning\n4. Ability to read, write, and speak English\n5. Stable doses of concomitant medications for last 2 weeks prior to enrollment\n6. Diagnosis of post-concussive syndrome according to Diagnostic and Statistical Manual 5 (DSM-5) criteria\n\nExclusion Criteria:\n\n1. Contraindication to sildenafil\n2. Past medical history or evidence of penetrating brain injury\n3. Daily therapy with a PDE5 inhibitor within the past 2 months, or taken as needed within past 4 weeks\n4. History or evidence of pre-existing disabling neurological or psychiatric disorder not related to previous head injuries\n5. History of melanoma\n6. History of diagnosed obstructive/ restrictive pulmonary disease 7 .) Contraindication to MRI'}, 'identificationModule': {'nctId': 'NCT03417492', 'briefTitle': 'Cerebrovascular Reactivity in American Football Players', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Cerebrovascular Reactivity Assessed With Functional Near-infrared Spectroscopy and Magnetic Resonance Imaging as a Biomarker of Traumatic Microvascular Injury in American Football Players', 'orgStudyIdInfo': {'id': '827103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sildenafil Citrate', 'description': 'Open label treatment with forced titration of sildenafil citrate.', 'interventionNames': ['Drug: Sildenafil Citrate']}], 'interventions': [{'name': 'Sildenafil Citrate', 'type': 'DRUG', 'otherNames': ['Open label forced titration with sildenafil citrate.'], 'description': 'Three 20 mg capsules for the single dose studies. For the 5-week treatment phase, subjects will be assigned to a titration of doses for the 5 week duration of the study. Subjects will be instructed to take 20mg twice per day for 3 days, then 40mg twice per day for 3 days, and then 80mg twice per day for 4 weeks.', 'armGroupLabels': ['Sildenafil Citrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn Presbyterian Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Presidential Professor', 'investigatorFullName': 'Ramon Diaz-Arrastia', 'investigatorAffiliation': 'University of Pennsylvania'}}}}