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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| antimuscarinic treatment | antimuscarinic treatment |
| |
| no antimuscarinic treatment (control) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antimuscarinic treatment | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| d2 Test | change from enrollement to 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients with acute (4-8 week post-injury) traumatic spinal cord injury during first rehabilitation
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| Name | Affiliation | Role |
|---|---|---|
| Jürgen Pannek, Prof | Swiss Paraplegic Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Paraplegic Centre | Nottwil | Canton of Lucerne | 6207 | Switzerland |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D013119 | Spinal Cord Injuries |
| D001750 | Urinary Bladder, Neurogenic |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013118 | Spinal Cord Diseases |
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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 |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |