Effects of Antimuscarinics on Cognition in Spinal Cord Injury

Swiss Paraplegic Research, Nottwil

Status: Completed

Conditions: Spinal Cord Injuries; Mild Cognitive Impairment

Treatments: Drug: antimuscarinic treatment

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01600404

2011-25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

32 participants in 2 patient groups

antimuscarinic treatment

Description:

antimuscarinic treatment

Treatment:

Drug: antimuscarinic treatment

no antimuscarinic treatment (control)