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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
LU
-
Nottwil、LU、瑞士、6207
- Swiss Paraplegic Centre
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
antimuscarinic treatment
|
|
|
no antimuscarinic treatment (control)
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
d2 Test
大体时间：change from enrollement to 3 months
|
change from enrollement to 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
International Spinal Cord Injury Pain Basic Data Set
大体时间：day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
Beck Depression Inventory Score
大体时间：day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
患者特征
大体时间：第 0 天
|
年龄
|
第 0 天
|
|
type of neurologic lower urinary tract dysfunction
大体时间：day 0
|
day 0
|
|
|
Stroop Test
大体时间：day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
California Verbal Learning Test
大体时间：day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
Verbal Fluency Test according to Thurstone
大体时间：day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
visuospatial performance
大体时间：day 0 and at 3 months
|
subtests from Wechsler Adult Intelligence Scale
|
day 0 and at 3 months
|
|
divided attention
大体时间：day 0 and at 3 months
|
subtests from test battery according to Zimmermann and Fimm
|
day 0 and at 3 months
|
|
患者特征
大体时间：第 0 天
|
性别
|
第 0 天
|
|
patient characteristics
大体时间：day 0
|
date of injury
|
day 0
|
|
patient characteristics
大体时间：day 0
|
tpe of accident
|
day 0
|
|
patient characteristics
大体时间：day 0
|
Glasgow Coma Scale
|
day 0
|
|
patient characteristics
大体时间：day 0
|
lesion level
|
day 0
|
|
patient characteristics
大体时间：day 0
|
completeness of injury
|
day 0
|
|
patient characteristics
大体时间：day 0
|
ASIA impairment score
|
day 0
|
合作者和调查者
调查人员
- 首席研究员：Jürgen Pannek, Prof、Swiss Paraplegic Centre
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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