Effects of Antimuscarinics on Cognition in Spinal Cord Injury
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01600404 |
Recruitment Status :
Completed
First Posted : May 17, 2012
Last Update Posted : November 17, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 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 |

Group/Cohort | Intervention/treatment |
---|---|
antimuscarinic treatment
antimuscarinic treatment
|
Drug: antimuscarinic treatment |
no antimuscarinic treatment (control) |
- d2 Test [ Time Frame: change from enrollement to 3 months ]
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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
Switzerland | |
Swiss Paraplegic Centre | |
Nottwil, LU, Switzerland, 6207 |
Principal Investigator: | Jürgen Pannek, Prof | Swiss Paraplegic Centre |
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 |