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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
LU
-
Nottwil、LU、スイス、6207
- Swiss Paraplegic Centre
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
antimuscarinic treatment
|
|
|
no antimuscarinic treatment (control)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
d2 Test
時間枠：change from enrollement to 3 months
|
change from enrollement to 3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
International Spinal Cord Injury Pain Basic Data Set
時間枠：day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
Beck Depression Inventory Score
時間枠：day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
患者の特徴
時間枠：0日目
|
年
|
0日目
|
|
type of neurologic lower urinary tract dysfunction
時間枠：day 0
|
day 0
|
|
|
Stroop Test
時間枠：day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
California Verbal Learning Test
時間枠：day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
Verbal Fluency Test according to Thurstone
時間枠：day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
visuospatial performance
時間枠：day 0 and at 3 months
|
subtests from Wechsler Adult Intelligence Scale
|
day 0 and at 3 months
|
|
divided attention
時間枠：day 0 and at 3 months
|
subtests from test battery according to Zimmermann and Fimm
|
day 0 and at 3 months
|
|
患者の特徴
時間枠：0日目
|
セックス
|
0日目
|
|
patient characteristics
時間枠：day 0
|
date of injury
|
day 0
|
|
patient characteristics
時間枠：day 0
|
tpe of accident
|
day 0
|
|
patient characteristics
時間枠：day 0
|
Glasgow Coma Scale
|
day 0
|
|
patient characteristics
時間枠：day 0
|
lesion level
|
day 0
|
|
patient characteristics
時間枠：day 0
|
completeness of injury
|
day 0
|
|
patient characteristics
時間枠：day 0
|
ASIA impairment score
|
day 0
|
協力者と研究者
捜査官
- 主任研究者：Jürgen Pannek, Prof、Swiss Paraplegic Centre
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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