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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
LU
-
Nottwil, LU, 스위스, 6207
- Swiss Paraplegic Centre
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
antimuscarinic treatment
|
|
|
no antimuscarinic treatment (control)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
d2 Test
기간: change from enrollement to 3 months
|
change from enrollement to 3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
International Spinal Cord Injury Pain Basic Data Set
기간: day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
Beck Depression Inventory Score
기간: day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
환자 특성
기간: 0일
|
나이
|
0일
|
|
type of neurologic lower urinary tract dysfunction
기간: day 0
|
day 0
|
|
|
Stroop Test
기간: day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
California Verbal Learning Test
기간: day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
Verbal Fluency Test according to Thurstone
기간: day 0 and at 3 months
|
day 0 and at 3 months
|
|
|
visuospatial performance
기간: day 0 and at 3 months
|
subtests from Wechsler Adult Intelligence Scale
|
day 0 and at 3 months
|
|
divided attention
기간: day 0 and at 3 months
|
subtests from test battery according to Zimmermann and Fimm
|
day 0 and at 3 months
|
|
환자 특성
기간: 0일
|
섹스
|
0일
|
|
patient characteristics
기간: day 0
|
date of injury
|
day 0
|
|
patient characteristics
기간: day 0
|
tpe of accident
|
day 0
|
|
patient characteristics
기간: day 0
|
Glasgow Coma Scale
|
day 0
|
|
patient characteristics
기간: day 0
|
lesion level
|
day 0
|
|
patient characteristics
기간: day 0
|
completeness of injury
|
day 0
|
|
patient characteristics
기간: day 0
|
ASIA impairment score
|
day 0
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jürgen Pannek, Prof, Swiss Paraplegic Centre
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
antimuscarinic treatment에 대한 임상 시험
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...모병
-
Riphah International University모병
-
Hallym University Medical Center아직 모집하지 않음자살 생각 | 자해 행위 | 자살 위험 | 청소년 정신 건강
-
Memorial Sloan Kettering Cancer Center종료됨
-
Beth Israel Deaconess Medical CenterMassachusetts General Hospital; National Center for Complementary and Integrative Health...모병
-
Assiut University모병
-
Guangdong Provincial People's Hospital아직 모집하지 않음만성 골수성 백혈병 | 무치료 관해