Effects of Antimuscarinics on Cognition in Spinal Cord Injury
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Purpose
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 | Intervention |
|---|---|
|
Mild Cognitive Impairment Spinal Cord Injuries |
Drug: antimuscarinic treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Antimuscarinic Drugs on the Cognition of Patients With Acute Spinal Cord Injury |
- d2 Test [ Time Frame: change from enrollement to 3 months ] [ Designated as safety issue: No ]
- International Spinal Cord Injury Pain Basic Data Set [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]
- Beck Depression Inventory Score [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]
- patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]age
- type of neurologic lower urinary tract dysfunction [ Time Frame: day 0 ] [ Designated as safety issue: No ]
- Stroop Test [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]
- California Verbal Learning Test [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]
- Verbal Fluency Test according to Thurstone [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]
- visuospatial performance [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]subtests from Wechsler Adult Intelligence Scale
- divided attention [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]subtests from test battery according to Zimmermann and Fimm
- patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]sex
- patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]date of injury
- patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]tpe of accident
- patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]Glasgow Coma Scale
- patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]lesion level
- patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]completeness of injury
- patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]ASIA impairment score
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: antimuscarinic treatment
antimuscarinic treatment
|
Drug: antimuscarinic treatment |
| No Intervention: no antimuscarinic treatment (control) |
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Jürgen Pannek, Prof | +41419395922 | jürgen.pannek@paranet.ch |
| Switzerland | |
| Swiss Paraplegic Centre | Recruiting |
| Nottwil, LU, Switzerland, 6207 | |
| Contact: Jürgen Pannek, Prof +41419395922 jürgen.pannek@paranet.ch | |
| Principal Investigator: Jürgen Pannek, Prof | |
| Principal Investigator: | Jürgen Pannek, Prof | Swiss Paraplegic Centre |
More Information
No publications provided
| Responsible Party: | Swiss Paraplegic Centre Nottwil |
| ClinicalTrials.gov Identifier: | NCT01600404 History of Changes |
| Other Study ID Numbers: | JP-004 |
| Study First Received: | May 10, 2012 |
| Last Updated: | October 2, 2012 |
| Health Authority: | Switzerland: Ethikkommission |
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:
|
Spinal Cord Injuries Cognition Disorders Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013