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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01600404
Other study ID # 2011-25
Secondary ID
Status Completed
Phase N/A
First received May 10, 2012
Last updated November 16, 2015
Start date December 2011
Est. completion date November 2015

Study information

Verified date November 2015
Source Swiss Paraplegic Centre Nottwil
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Drug:
antimuscarinic treatment


Locations

Country Name City State
Switzerland Swiss Paraplegic Centre Nottwil LU

Sponsors (1)

Lead Sponsor Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary d2 Test change from enrollement to 3 months No
Secondary International Spinal Cord Injury Pain Basic Data Set day 0 and at 3 months No
Secondary Beck Depression Inventory Score day 0 and at 3 months No
Secondary patient characteristics age day 0 No
Secondary type of neurologic lower urinary tract dysfunction day 0 No
Secondary Stroop Test day 0 and at 3 months No
Secondary California Verbal Learning Test day 0 and at 3 months No
Secondary Verbal Fluency Test according to Thurstone day 0 and at 3 months No
Secondary visuospatial performance subtests from Wechsler Adult Intelligence Scale day 0 and at 3 months No
Secondary divided attention subtests from test battery according to Zimmermann and Fimm day 0 and at 3 months No
Secondary patient characteristics sex day 0 No
Secondary patient characteristics date of injury day 0 No
Secondary patient characteristics tpe of accident day 0 No
Secondary patient characteristics Glasgow Coma Scale day 0 No
Secondary patient characteristics lesion level day 0 No
Secondary patient characteristics completeness of injury day 0 No
Secondary patient characteristics ASIA impairment score day 0 No
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