Effects of Antimuscarinics on Cognition in Spinal Cord Injury

Study Overview
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Brief Summary
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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. The 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.

Detailed Description
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There will be two groups: 1) patients receiving antimuscarinic treatment 2) patients without antimuscarinic treatment (control). The 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. Six 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. Prior 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). Furthermore,different factors influencing cognition, e.g. depression, pain, medication, will be assessed at the beginning and end of the study.

Official Title
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Effects of Antimuscarinic Drugs on the Cognition of Patients With Acute Spinal Cord Injury

Conditions
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Mild Cognitive Impairment, Spinal Cord Injuries

Intervention / Treatment
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* Drug: antimuscarinic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute traumatic spinal cord injury primary rehabilitation / in-house patient 18-65 years of age treatment group: indication for antimuscarinic treatment (oxybutynin, tolterodine willingness and motivation to participate in study Exclusion Criteria: lesion level above C4 traumatic brain injury (initial Glasgow Coma Score < 13) pre-existing dementia pre-existing impaired cognitive function previous antimuscarinic treatment treatment group: antimuscarinic treatment other than oxybutynin, tolterodine acute psychologic disorders, diseases, schizophrenia alcohol abuse, consumption of illegal drugs (incl. marijuana) moderate to severe depression (Beck Depression Inventory Score > 18) moderate to severe pain (International Spinal Cord Injury Pain Basic Data Set) progressive disease tricyclic antidepressant color blindness, impaired sight, blindness insufficient German language skills no informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| antimuscarinic treatment<br>antimuscarinic treatment | Drug: antimuscarinic treatment<br> <br> |
| no antimuscarinic treatment (control)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| d2 Test |  | change from enrollement to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Spinal Cord Injury Pain Basic Data Set |  | day 0 and at 3 months | 
| Beck Depression Inventory Score |  | day 0 and at 3 months | 
| patient characteristics | age | day 0 | 
| type of neurologic lower urinary tract dysfunction |  | day 0 | 
| Stroop Test |  | day 0 and at 3 months | 
| California Verbal Learning Test |  | day 0 and at 3 months | 
| Verbal Fluency Test according to Thurstone |  | day 0 and at 3 months | 
| visuospatial performance | subtests from Wechsler Adult Intelligence Scale | day 0 and at 3 months | 
| divided attention | subtests from test battery according to Zimmermann and Fimm | day 0 and at 3 months | 
| patient characteristics | sex | day 0 | 
| patient characteristics | date of injury | day 0 | 
| patient characteristics | tpe of accident | day 0 | 
| patient characteristics | Glasgow Coma Scale | day 0 | 
| patient characteristics | lesion level | day 0 | 
| patient characteristics | completeness of injury | day 0 | 
| patient characteristics | ASIA impairment score | day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Cognitive Impairment, Muscarinic Antagonists, Spinal Cord Injuries, Urinary Bladder, Neurogenic, Urinary Bladder, Overactive, Overactive Detrusor