Effects of Antimuscarinics on Cognition in Spinal Cord Injury

Mild Cognitive Impairment Clinical Trial

Official title:

Effects of Antimuscarinic Drugs on the Cognition of Patients With Acute Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600404
• Other study ID #: 2011-25
• Status: Completed
• Phase: N/A
• First received: May 10, 2012
• Last updated: November 16, 2015
• Start date: December 2011
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment
• Spinal Cord Injuries

Intervention

Drug:
• antimuscarinic treatment

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	d2 Test		change from enrollement to 3 months	No
Secondary	International Spinal Cord Injury Pain Basic Data Set		day 0 and at 3 months	No
Secondary	Beck Depression Inventory Score		day 0 and at 3 months	No
Secondary	patient characteristics	age	day 0	No
Secondary	type of neurologic lower urinary tract dysfunction		day 0	No
Secondary	Stroop Test		day 0 and at 3 months	No
Secondary	California Verbal Learning Test		day 0 and at 3 months	No
Secondary	Verbal Fluency Test according to Thurstone		day 0 and at 3 months	No
Secondary	visuospatial performance	subtests from Wechsler Adult Intelligence Scale	day 0 and at 3 months	No
Secondary	divided attention	subtests from test battery according to Zimmermann and Fimm	day 0 and at 3 months	No
Secondary	patient characteristics	sex	day 0	No
Secondary	patient characteristics	date of injury	day 0	No
Secondary	patient characteristics	tpe of accident	day 0	No
Secondary	patient characteristics	Glasgow Coma Scale	day 0	No
Secondary	patient characteristics	lesion level	day 0	No
Secondary	patient characteristics	completeness of injury	day 0	No
Secondary	patient characteristics	ASIA impairment score	day 0	No