Clinical trial NCT01600404: Effects of Antimuscarinics on Cognition in Spinal Cord Injury
Official title: Effects of Antimuscarinic Drugs on the Cognition of Patients With Acute Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Spinal Cord Injuries
Keywords: Mild Cognitive Impairment
Muscarinic Antagonists
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Urinary Bladder, Overactive
Overactive Detrusor
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2012-05-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with acute (4-8 week post-injury) traumatic spinal cord injury during first rehabilitation

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.

Eligibility criteria: 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

Primary outcomes:
measure: d2 Test
timeFrame: change from enrollement to 3 months
Secondary outcomes:
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
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
measure: divided attention
timeFrame: day 0 and at 3 months
measure: patient characteristics
timeFrame: day 0
measure: patient characteristics
timeFrame: day 0
measure: patient characteristics
timeFrame: day 0
measure: patient characteristics
timeFrame: day 0
measure: patient characteristics
timeFrame: day 0
measure: patient characteristics
timeFrame: day 0
measure: patient characteristics
timeFrame: day 0
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
affiliation: Swiss Paraplegic Centre
name: Jürgen Pannek, Prof
role: PRINCIPAL_INVESTIGATOR
References: