Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-30 @ 1:36 AM
Study NCT ID:
NCT01085903
Status:
COMPLETED
Last Update Posted:
2016-10-18
First Post:
2010-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'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': 'D000077408', 'term': 'Modafinil'}, {'id': 'D005741', 'term': 'Noble Gases'}, {'id': 'C074807', 'term': 'BaseLine dental cement'}], 'ancestors': [{'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'msmennemeier@uams.edu', 'phone': '501 526 7773', 'title': 'Mark Mennemeier, PhD', 'organization': 'University of Arkansas for Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': 'Adverse Events were recorded in a cumulative fashion for stroke participants, and not according to the intervention received at the time of the event or according to the assigned intervention sequence.', 'eventGroups': [{'id': 'EG000', 'title': 'Normal Subjects', 'description': "Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.\n\nPost CPS: 20 minutes following the CPS condition.\n\nFollow up: Follow up testing occurred at 3 months", 'otherNumAtRisk': 21, 'otherNumAffected': 1, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stroke Subjects', 'description': "Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.\n\nModafinil: 200 mg once daily with morning meal for three days administered only to stroke patients\n\nPlacebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.\n\nPost CPS: 20 minutes following the CPS condition.\n\nFollow up: Follow up testing occurred at 3 months", 'otherNumAtRisk': 7, 'otherNumAffected': 6, 'seriousNumAtRisk': 7, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'vasovagal response', 'notes': 'One normal subject had a vasovagal response during the swallowing evaluation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'notes': 'headache with or without dizzyness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'rash', 'notes': 'rash with or without itchyness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'difficulty sleeping', 'notes': 'report of difficulty sleeping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'stroke', 'notes': 'One participant had an additional stroke that was unrelated to the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'broken hip', 'notes': 'one participant broke a hip but this was not related to the study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'P50 Percent Habituation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Subjects: Baseline vs CPS', 'description': "Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds."}, {'id': 'OG001', 'title': 'Stroke Subjects: Baseline vs CPS', 'description': "Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds."}, {'id': 'OG002', 'title': 'Stroke Subjects: Modafinil', 'description': 'Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients'}, {'id': 'OG003', 'title': 'Stroke Subjects: Placebo', 'description': 'Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients'}, {'id': 'OG004', 'title': 'Stroke Subjects Placebo vs Modafinil', 'description': 'Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients\n\nModafinil: 200 mg once daily with morning meal for three days administered only to stroke patients'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.12', 'spread': '59.29', 'groupId': 'OG000'}, {'value': '-45.84', 'spread': '228.09', 'groupId': 'OG001'}, {'value': '113.63', 'spread': '154.5', 'groupId': 'OG002'}, {'value': '61.41', 'spread': '102.5', 'groupId': 'OG003'}, {'value': '52.223', 'spread': '222.94', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and after three days of intervention', 'description': 'This is an electrophysiological measure of arousal - a percent change in the P50 evoked response potential amplitudes with a 250 ms inter stimulus interval. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).', 'unitOfMeasure': 'percentage of change in amplitude', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PVT Fastest 10 Percent of Reaction Times', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Subjects: Baseline vs CPS', 'description': "Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds."}, {'id': 'OG001', 'title': 'Stroke Subjects: Baseline vs CPS', 'description': "Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds."}, {'id': 'OG002', 'title': 'Stroke Subjects: Modafinil', 'description': 'Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.\n\nModafinil: 200 mg once daily with morning meal for three days administered only to stroke patients'}, {'id': 'OG003', 'title': 'Stroke Subjects: Placebo', 'description': 'Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.\n\nPlacebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients'}, {'id': 'OG004', 'title': 'Stroke Subjects Placebo vs Modafinil', 'description': 'Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.\n\nModafinil: 200 mg once daily with morning meal for three days administered only to stroke patients\n\nPlacebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.57', 'spread': '21.66', 'groupId': 'OG000'}, {'value': '20.57', 'spread': '29.20', 'groupId': 'OG001'}, {'value': '244.71', 'spread': '186.62', 'groupId': 'OG002'}, {'value': '235.64', 'spread': '150.62', 'groupId': 'OG003'}, {'value': '9.07', 'spread': '38.73', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and after three days of intervention', 'description': 'This is a behavioral measure of arousal - the fastest 10 percent of all cued reaction time trials. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Power Function Exponent for Oral Bolus Estimation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Subjects: Baseline vs CPS', 'description': "Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds."}, {'id': 'OG001', 'title': 'Stroke Subjects: Baseline vs CPS', 'description': "Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds."}, {'id': 'OG002', 'title': 'Stroke Subjects: Modafinil', 'description': 'Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.\n\nModafinil: 200 mg once daily with morning meal for three days administered only to stroke patients'}, {'id': 'OG003', 'title': 'Stroke Subjects: Placebo', 'description': 'Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.\n\nPlacebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients'}, {'id': 'OG004', 'title': 'Stroke Subjects Placebo vs Modafinil', 'description': 'Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.\n\nModafinil: 200 mg once daily with morning meal for three days administered only to stroke patients\n\nPlacebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients'}], 'classes': [{'categories': [{'measurements': [{'value': '.014', 'spread': '.113', 'groupId': 'OG000'}, {'value': '-.004', 'spread': '.196', 'groupId': 'OG001'}, {'value': '.54', 'spread': '.17', 'groupId': 'OG002'}, {'value': '.49', 'spread': '.19', 'groupId': 'OG003'}, {'value': '.04', 'spread': '.08', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and after three days of intervention', 'description': "This is a behavioral measure of sensation in the oral cavity. The power function exponent is equal to the slope of a regression equation relating bolus size to a person's estimate of that size. An exponent below one implies an underestimate of bolus size. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).", 'unitOfMeasure': 'exponent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Swallow Puree Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Subjects: Baseline vs CPS', 'description': "Normal subjects are persons without stroke who receive baseline and CPS conditions.\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds."}, {'id': 'OG001', 'title': 'Stroke Subjects: Baseline vs CPS', 'description': "Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds."}, {'id': 'OG002', 'title': 'Stroke Subjects: Modafinil', 'description': 'Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.\n\nModafinil: 200 mg once daily with morning meal for three days administered only to stroke patients'}, {'id': 'OG003', 'title': 'Stroke Subjects: Placebo', 'description': 'Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.\n\nPlacebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients'}, {'id': 'OG004', 'title': 'Stroke Subjects Placebo vs Modafinil', 'description': 'Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.\n\nModafinil: 200 mg once daily with morning meal for three days administered only to stroke patients\n\nPlacebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patientseal for three days administered only to stroke patients'}], 'classes': [{'categories': [{'measurements': [{'value': '.029', 'spread': '.121', 'groupId': 'OG000'}, {'value': '-.058', 'spread': '.512', 'groupId': 'OG001'}, {'value': '.48', 'spread': '1.05', 'groupId': 'OG002'}, {'value': '.12', 'spread': '.11', 'groupId': 'OG003'}, {'value': '.36', 'spread': '1.06', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and after three days of intervention', 'description': 'This is a behavioral measure of swallowing - the time it takes for pureed food to transition across a part of the throat. The difference score is calculated as CPS - placebo and as modafinil - placebo (for stroke subjects only).', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Subjects Baseline', 'description': "Normal subjects are persons without stroke who receive baseline, Cold Pressor Stimulation (CPS), Post CPS and Follow up interventions.\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.\n\nPost CPS: 20 minutes following the CPS condition."}, {'id': 'FG001', 'title': 'Stroke Subjects: Placebo Then Modafinil', 'description': "Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients\n\nPlacebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.\n\nPost CPS: 20 minutes following the CPS condition."}, {'id': 'FG002', 'title': 'Stroke Subjects: Modafinil Then Placebo', 'description': "Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients\n\nPlacebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.\n\nPost CPS: 20 minutes following the CPS condition."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Subjects', 'description': "Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.\n\nPost CPS: 20 minutes following the CPS condition."}, {'id': 'BG001', 'title': 'Stroke Subjects', 'description': "Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline, CPS, and Post CPS and then are randomized to modafinil or placebo.\n\nBaseline: Observations made at baseline before any intervention\n\nCPS: Submerging each participant's foot into ice water (36-44 F) for 50 seconds.\n\nPost CPS: 20 minutes following the CPS condition. Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients\n\nPlacebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.286', 'spread': '21.462', 'groupId': 'BG000'}, {'value': '71.429', 'spread': '9.914', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '15.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2010-03-09', 'resultsFirstSubmitDate': '2016-07-25', 'studyFirstSubmitQcDate': '2010-03-11', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-17', 'studyFirstPostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'P50 Percent Habituation Score', 'timeFrame': 'baseline and after three days of intervention', 'description': 'This is an electrophysiological measure of arousal - a percent change in the P50 evoked response potential amplitudes with a 250 ms inter stimulus interval. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).'}], 'secondaryOutcomes': [{'measure': 'PVT Fastest 10 Percent of Reaction Times', 'timeFrame': 'baseline and after three days of intervention', 'description': 'This is a behavioral measure of arousal - the fastest 10 percent of all cued reaction time trials. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).'}, {'measure': 'Power Function Exponent for Oral Bolus Estimation', 'timeFrame': 'baseline and after three days of intervention', 'description': "This is a behavioral measure of sensation in the oral cavity. The power function exponent is equal to the slope of a regression equation relating bolus size to a person's estimate of that size. An exponent below one implies an underestimate of bolus size. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only)."}, {'measure': 'Time to Swallow Puree Food', 'timeFrame': 'baseline and after three days of intervention', 'description': 'This is a behavioral measure of swallowing - the time it takes for pureed food to transition across a part of the throat. The difference score is calculated as CPS - placebo and as modafinil - placebo (for stroke subjects only).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Spatial Neglect', 'Dysphagia', 'Arousal', 'Modafinil', 'Stroke'], 'conditions': ['Spatial Neglect', 'Dysphagia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine how stroke can alter arousal, alertness, neglect and dysphagia, and whether a medication, modafinil, can improve arousal.', 'detailedDescription': "Neglect and dysphagia are two of the most problematic behavioral disorders encountered in stroke rehabilitation with 300,000 patients affected annually in the US. Both disorders impede progress in therapy and both lead to costly medical complications, like falls which are associated with neglect and aspiration pneumonia and malnutrition which are associated with dysphagia. No widely accepted pharmacological treatment exists for either disorder.\n\nA new direction of this application is to view neglect and dysphagia as different disorders that share a common deficit in magnitude estimation (ME). ME refers to one's ability to perceive the intensity of sensory stimulation. Deficits in ME explain how much of a stimulus is neglected by stroke patients. Sensory deficits are also known to produce dysphagia. Perceptual deficits influence how patients response to stimuli like failing to act on all stimuli present (neglect) and failing to generate swallowing reflexes sufficient for normal bolus flow (dysphagia).\n\nWe know from previous work that ME is altered by change in cortical arousal following stroke (decreased or hypoarousal). Hypoarousal is evidenced by objective and subjective post-stroke fatigue and daytime sleepiness which occurs in 50% of stroke patients and can persist chronically. Increasing arousal could potentially reverse the perceptual deficits associated with hypoarousal and improve neglect and dysphagia. This proposal manipulates arousal in two ways. Cold pressor stimulation (CPS), immersing the foot in cold water for 50 seconds, is used to increase arousal and reverse neglect and dysphagia temporarily. A brief, 3-day trial of modafinil (Provigil) versus placebo is then used in stroke patients to learn if a positive response to cold-pressor stimulation can predicts patients who respond positively to modafinil."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent\n* Willingness to complete study procedures\n* Ability to comprehend and sign informed consent\n* Evidence of unilateral, ischemic stroke based on:\n\n * Neuroimaging (clinically obtained imaging studies showing evidence of stroke)\n\n * Acceptable categories of stroke include:\n * Unilateral ischemic stroke\n * Atherothrombotic stroke\n * Cardioembolic stroke\n * Lacunar stroke \\>1.5 cm\n * Chronic stable, unilateral hemorrhagic stroke\n* Or Behavioral evidence of stroke including:\n\n * Hemiplegia\n * Unilateral sensory impairment\n * Localized higher cortical dysfunction (e.g. neglect,dysphagia, apraxia)\n\nExclusion Criteria:\n\n* Cardiac valvular disease\n* Left heart hypertrophy\n* Poorly controlled hypertension\n* Active variant angina\n* Pre-menopausal women capable of having children, including those using active contraception (precaution for study medication and not applicable to normal subjects)\n* Severe renal or hepatic disease\n* History of psychosis or substance abuse\n* Patients on other Central Nervous System (CNS) stimulants, dopamine agonists or antagonists (antipsychotics)\n* Severe speech comprehension deficit and/or inability to communicate responses\n* Allergies that could put the research subject at risk during the course of the study\n* Cannot speak English\n* Active cerebral neurologic disease other than stroke such as multiple sclerosis or Alzheimer's Disease\n* Active psychiatric illness except past history of treated depression or anxiety disorders\n* For persons needing an MRI - standard MRI exclusion criteria (cardiac pacemaker or defibrillator, artificial heart valves, metallic aneurysm clips eye or ear implants, implanted insulin or infusion pumps, battery activated stimulators, and history of claustrophobia)\n* Concomitant medications excluded: Based on recommendations of manufacturer, the following concomitant medications are excluded: Tricyclic antidepressants and Monoamine oxidase (MAO) inhibitors. Any other CNS stimulation producing medications. Antifungal agents Itraconazole or Ketoconazole as plasma concentrations of modafinil may be increased.\n* Stroke patients will be excluded from the modafinil trial if they cannot swallow a capsule.\n* Stroke patients are excluded if they are able to become pregnant\n* Any other criteria that the PI or study physicians feel would put the volunteer's health at risk during the course of the study"}, 'identificationModule': {'nctId': 'NCT01085903', 'briefTitle': 'Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia', 'orgStudyIdInfo': {'id': '110644'}, 'secondaryIdInfos': [{'id': 'R21HD055677', 'link': 'https://reporter.nih.gov/quickSearch/R21HD055677', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'normal subjects', 'description': 'Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.', 'interventionNames': ['Behavioral: Baseline', 'Behavioral: CPS', 'Behavioral: Post CPS', 'Behavioral: Follow up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'stroke subjects', 'description': 'Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.', 'interventionNames': ['Drug: Modafinil', 'Drug: Placebo', 'Behavioral: Baseline', 'Behavioral: CPS', 'Behavioral: Post CPS', 'Behavioral: Follow up']}], 'interventions': [{'name': 'Modafinil', 'type': 'DRUG', 'otherNames': ['Provigil'], 'description': '200 mg once daily with morning meal for three days administered only to stroke patients', 'armGroupLabels': ['stroke subjects']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['inert'], 'description': 'Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients', 'armGroupLabels': ['stroke subjects']}, {'name': 'Baseline', 'type': 'BEHAVIORAL', 'otherNames': ['baseline observation'], 'description': 'Observations made at baseline before any intervention', 'armGroupLabels': ['normal subjects', 'stroke subjects']}, {'name': 'CPS', 'type': 'BEHAVIORAL', 'otherNames': ['cold pressor stimulation'], 'description': "Submerging each participant's foot into ice water (36-44 F) for 50 seconds.", 'armGroupLabels': ['normal subjects', 'stroke subjects']}, {'name': 'Post CPS', 'type': 'BEHAVIORAL', 'otherNames': ['post cold pressor stimulation'], 'description': '20 minutes following the CPS condition.', 'armGroupLabels': ['normal subjects', 'stroke subjects']}, {'name': 'Follow up', 'type': 'BEHAVIORAL', 'otherNames': ['three month follow up'], 'description': 'Follow up testing occurred at 3 months', 'armGroupLabels': ['normal subjects', 'stroke subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72035', 'city': 'Conway', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Conway Regional Rehabilitation Hospital', 'geoPoint': {'lat': 35.0887, 'lon': -92.4421}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Mark S Mennemeier, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}, {'name': 'Gary McCullough, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Central Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}