Effects of Antimuscarinics on Cognition in Spinal Cord Injury
NCT ID: NCT01600404
Last Updated: 2015-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
32 participants
OBSERVATIONAL
2011-12-31
2015-11-30
Brief Summary
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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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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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antimuscarinic treatment
antimuscarinic treatment
antimuscarinic treatment
no antimuscarinic treatment (control)
No interventions assigned to this group
Interventions
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antimuscarinic treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Swiss Paraplegic Research, Nottwil
NETWORK
Responsible Party
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Principal Investigators
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Jürgen Pannek, Prof
Role: PRINCIPAL_INVESTIGATOR
Swiss Paraplegic Centre
Locations
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Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, Switzerland
Countries
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Other Identifiers
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2011-25
Identifier Type: -
Identifier Source: org_study_id