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Effects of Antimuscarinics on Cognition in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01600404
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

Study Description
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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.


Condition or disease Intervention/treatment
Mild Cognitive Impairment Spinal Cord Injuries Drug: antimuscarinic treatment

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
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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Antimuscarinic Drugs on the Cognition of Patients With Acute Spinal Cord Injury
Study Start Date : December 2011
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
antimuscarinic treatment
antimuscarinic treatment
 Drug: antimuscarinic treatment
no antimuscarinic treatment (control)


Outcome Measures
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Primary Outcome Measures :
  1. d2 Test [ Time Frame: change from enrollement to 3 months ]

Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with acute (4-8 week post-injury) traumatic spinal cord injury during first rehabilitation
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600404


Locations
Switzerland
Swiss Paraplegic Centre
Nottwil, LU, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
Principal Investigator: Jürgen Pannek, Prof Swiss Paraplegic Centre
More Information
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Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT01600404     History of Changes
Other Study ID Numbers: 2011‐25
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by Swiss Paraplegic Centre Nottwil:
Mild Cognitive Impairment
Muscarinic Antagonists
Spinal Cord Injuries
 Urinary Bladder, Neurogenic
Urinary Bladder, Overactive
Overactive Detrusor

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Cognitive Dysfunction
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Cognition Disorders
 Neurocognitive Disorders
Mental Disorders
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs