Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT01600404
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2012-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Antimuscarinics on Cognition in Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-16', 'studyFirstSubmitDate': '2012-05-10', 'studyFirstSubmitQcDate': '2012-05-15', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'd2 Test', 'timeFrame': 'change from enrollement to 3 months'}], 'secondaryOutcomes': [{'measure': 'International Spinal Cord Injury Pain Basic Data Set', 'timeFrame': 'day 0 and at 3 months'}, {'measure': 'Beck Depression Inventory Score', 'timeFrame': 'day 0 and at 3 months'}, {'measure': 'patient characteristics', 'timeFrame': 'day 0', 'description': 'age'}, {'measure': 'type of neurologic lower urinary tract dysfunction', 'timeFrame': 'day 0'}, {'measure': 'Stroop Test', 'timeFrame': 'day 0 and at 3 months'}, {'measure': 'California Verbal Learning Test', 'timeFrame': 'day 0 and at 3 months'}, {'measure': 'Verbal Fluency Test according to Thurstone', 'timeFrame': 'day 0 and at 3 months'}, {'measure': 'visuospatial performance', 'timeFrame': 'day 0 and at 3 months', 'description': 'subtests from Wechsler Adult Intelligence Scale'}, {'measure': 'divided attention', 'timeFrame': 'day 0 and at 3 months', 'description': 'subtests from test battery according to Zimmermann and Fimm'}, {'measure': 'patient characteristics', 'timeFrame': 'day 0', 'description': 'sex'}, {'measure': 'patient characteristics', 'timeFrame': 'day 0', 'description': 'date of injury'}, {'measure': 'patient characteristics', 'timeFrame': 'day 0', 'description': 'tpe of accident'}, {'measure': 'patient characteristics', 'timeFrame': 'day 0', 'description': 'Glasgow Coma Scale'}, {'measure': 'patient characteristics', 'timeFrame': 'day 0', 'description': 'lesion level'}, {'measure': 'patient characteristics', 'timeFrame': 'day 0', 'description': 'completeness of injury'}, {'measure': 'patient characteristics', 'timeFrame': 'day 0', 'description': 'ASIA impairment score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mild Cognitive Impairment', 'Muscarinic Antagonists', 'Spinal Cord Injuries', 'Urinary Bladder, Neurogenic', 'Urinary Bladder, Overactive', 'Overactive Detrusor'], 'conditions': ['Mild Cognitive Impairment', 'Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'Prospective evaluation of the cognitive function of in-house patients suffering from an acute traumatic spinal cord injury before and three months after the initiation of antimuscarinic treatment.\n\nThe following hypothesis will be tested: Antimuscarinic treatment results in significantly worse cognitive test results three months after traumatic spinal cord injury compared to the pre-treatment results and the results of the control group.', 'detailedDescription': 'There will be two groups: 1) patients receiving antimuscarinic treatment 2) patients without antimuscarinic treatment (control).\n\nThe control group will be investigated in order to determine the effects of traumatic spinal cord injury on cognition and the natural history of potential cognitive impairment within the first three months after spinal cord injury.\n\nSix to eight weeks after traumatic spinal cord injury, patients are examined in order to determine the type of neurogenic bladder dysfunction they are suffering from. Patients suffering from an overactive bladder will receive antimuscarinic treatment in order to prevent high urine storage and voiding pressures, that put the kidneys at risk.\n\nPrior to the urologic examination, patients fulfilling inclusion criteria will be contacted. If informed consent is given, cognitive function will be evaluated in both patient groups using different standard neuropsychologic tests. The same neuropsychologic tests will be repeated three months later. Evaluation will take place under standardized conditions (e.g. time of day).\n\nFurthermore,different factors influencing cognition, e.g. depression, pain, medication, will be assessed at the beginning and end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with acute (4-8 week post-injury) traumatic spinal cord injury during first rehabilitation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute traumatic spinal cord injury\n* primary rehabilitation / in-house patient\n* 18-65 years of age\n* treatment group: indication for antimuscarinic treatment (oxybutynin, tolterodine\n* willingness and motivation to participate in study\n\nExclusion Criteria:\n\n* lesion level above C4\n* traumatic brain injury (initial Glasgow Coma Score \\< 13)\n* pre-existing dementia\n* pre-existing impaired cognitive function\n* previous antimuscarinic treatment\n* treatment group: antimuscarinic treatment other than oxybutynin, tolterodine\n* acute psychologic disorders, diseases, schizophrenia\n* alcohol abuse, consumption of illegal drugs (incl. marijuana)\n* moderate to severe depression (Beck Depression Inventory Score \\> 18)\n* moderate to severe pain (International Spinal Cord Injury Pain Basic Data Set)\n* progressive disease\n* tricyclic antidepressant\n* color blindness, impaired sight, blindness\n* insufficient German language skills\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT01600404', 'briefTitle': 'Effects of Antimuscarinics on Cognition in Spinal Cord Injury', 'organization': {'class': 'NETWORK', 'fullName': 'Swiss Paraplegic Research, Nottwil'}, 'officialTitle': 'Effects of Antimuscarinic Drugs on the Cognition of Patients With Acute Spinal Cord Injury', 'orgStudyIdInfo': {'id': '2011-25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'antimuscarinic treatment', 'description': 'antimuscarinic treatment', 'interventionNames': ['Drug: antimuscarinic treatment']}, {'label': 'no antimuscarinic treatment (control)'}], 'interventions': [{'name': 'antimuscarinic treatment', 'type': 'DRUG', 'armGroupLabels': ['antimuscarinic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6207', 'city': 'Nottwil', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Swiss Paraplegic Centre', 'geoPoint': {'lat': 47.13469, 'lon': 8.13774}}], 'overallOfficials': [{'name': 'Jürgen Pannek, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Paraplegic Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Paraplegic Research, Nottwil', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}