Effects of Antimuscarinic Drugs on the Cognition of Patients With Acute Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- d2 Test
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
antimuscarinic treatment
antimuscarinic treatment
Intervention: antimuscarinic treatment (Drug)
Outcomes
Primary Outcomes
d2 Test
Time Frame: change from enrollement to 3 months
Secondary Outcomes
- Beck Depression Inventory Score(day 0 and at 3 months)
- divided attention(day 0 and at 3 months)
- International Spinal Cord Injury Pain Basic Data Set(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)
- patient characteristics(day 0)
- type of neurologic lower urinary tract dysfunction(day 0)
- Stroop Test(day 0 and at 3 months)
- visuospatial performance(day 0 and at 3 months)