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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

May 10, 2012
May 17, 2012
November 17, 2015
December 2011
November 2015   (Final data collection date for primary outcome measure)
d2 Test [ Time Frame: change from enrollement to 3 months ]
Same as current
Complete list of historical versions of study NCT01600404 on ClinicalTrials.gov Archive Site
  • International Spinal Cord Injury Pain Basic Data Set [ Time Frame: day 0 and at 3 months ]
  • Beck Depression Inventory Score [ Time Frame: day 0 and at 3 months ]
  • patient characteristics [ Time Frame: day 0 ]
    age
  • type of neurologic lower urinary tract dysfunction [ Time Frame: day 0 ]
  • Stroop Test [ Time Frame: day 0 and at 3 months ]
  • California Verbal Learning Test [ Time Frame: day 0 and at 3 months ]
  • Verbal Fluency Test according to Thurstone [ Time Frame: day 0 and at 3 months ]
  • visuospatial performance [ Time Frame: day 0 and at 3 months ]
    subtests from Wechsler Adult Intelligence Scale
  • divided attention [ Time Frame: day 0 and at 3 months ]
    subtests from test battery according to Zimmermann and Fimm
  • patient characteristics [ Time Frame: day 0 ]
    sex
  • patient characteristics [ Time Frame: day 0 ]
    date of injury
  • patient characteristics [ Time Frame: day 0 ]
    tpe of accident
  • patient characteristics [ Time Frame: day 0 ]
    Glasgow Coma Scale
  • patient characteristics [ Time Frame: day 0 ]
    lesion level
  • patient characteristics [ Time Frame: day 0 ]
    completeness of injury
  • patient characteristics [ Time Frame: day 0 ]
    ASIA impairment score
  • International Spinal Cord Injury Pain Basic Data Set [ Time Frame: day 0 and at 3 months ]
  • Beck Depression Inventory Score [ Time Frame: day 0 and at 3 months ]
  • patient characteristics [ Time Frame: day 0 ]
    age
  • type of neurologic lower urinary tract dysfunction [ Time Frame: day 0 ]
  • Stroop Test [ Time Frame: day 0 and at 3 months ]
  • California Verbal Learning Test [ Time Frame: day 0 and at 3 months ]
  • Verbal Fluency Test according to Thurstone [ Time Frame: day 0 and at 3 months ]
  • visuospatial performance [ Time Frame: day 0 and at 3 months ]
    subtests from Wechsler Adult Intelligence Scale
  • divided attention [ Time Frame: day 0 and at 3 months ]
    subtests from test battery accordng to Zimmermann and Fimm
  • patient characteristics [ Time Frame: day 0 ]
    sex
  • patient characteristics [ Time Frame: day 0 ]
    date of injury
  • patient characteristics [ Time Frame: day 0 ]
    tpe of accident
  • patient characteristics [ Time Frame: day 0 ]
    Glasgow Coma Scale
  • patient characteristics [ Time Frame: day 0 ]
    lesion level
  • patient characteristics [ Time Frame: day 0 ]
    completeness of inury
  • patient characteristics [ Time Frame: day 0 ]
    ASIA impairment score
Not Provided
Not Provided
 
Effects of Antimuscarinics on Cognition in Spinal Cord Injury
Effects of Antimuscarinic Drugs on the Cognition of Patients With Acute 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
patients with acute (4-8 week post-injury) traumatic spinal cord injury during first rehabilitation
  • Mild Cognitive Impairment
  • Spinal Cord Injuries
Drug: antimuscarinic treatment
  • antimuscarinic treatment
    antimuscarinic treatment
    Intervention: Drug: antimuscarinic treatment
  • no antimuscarinic treatment (control)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
40
November 2015
November 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01600404
2011‐25
No
Not Provided
Not Provided
Swiss Paraplegic Centre Nottwil
Swiss Paraplegic Centre Nottwil
Not Provided
Principal Investigator: Jürgen Pannek, Prof Swiss Paraplegic Centre
Swiss Paraplegic Centre Nottwil
November 2015