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Completed

NCT Number: NCT01600404

Effects of Antimuscarinics on Cognition in Spinal Cord Injury

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antimuscarinic treatment

Drug

Primary outcomes

  1. d2 Test

    Time frame: change from enrollement to 3 months

Secondary outcomes

  1. International Spinal Cord Injury Pain Basic Data Set

    Time frame: day 0 and at 3 months

  2. Beck Depression Inventory Score

    Time frame: day 0 and at 3 months

  3. patient characteristics

    Time frame: day 0

    age

  4. type of neurologic lower urinary tract dysfunction

    Time frame: day 0

  5. Stroop Test

    Time frame: day 0 and at 3 months

  6. California Verbal Learning Test

    Time frame: day 0 and at 3 months

  7. Verbal Fluency Test according to Thurstone

    Time frame: day 0 and at 3 months

  8. visuospatial performance

    Time frame: day 0 and at 3 months

    subtests from Wechsler Adult Intelligence Scale

  9. divided attention

    Time frame: day 0 and at 3 months

    subtests from test battery according to Zimmermann and Fimm

  10. patient characteristics

    Time frame: day 0

    sex

  11. patient characteristics

    Time frame: day 0

    date of injury

  12. patient characteristics

    Time frame: day 0

    tpe of accident

  13. patient characteristics

    Time frame: day 0

    Glasgow Coma Scale

  14. patient characteristics

    Time frame: day 0

    lesion level

  15. patient characteristics

    Time frame: day 0

    completeness of injury

  16. patient characteristics

    Time frame: day 0

    ASIA impairment score

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

Effects of Antimuscarinic Drugs on the Cognition of Patients With Acute Spinal Cord Injury

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 17, 2012
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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