- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04960540
Multimodal Brain Imaging Study
Multimodal Brain Imaging Study of Language Cognitive Function in Patients With Amyotrophic Lateral Sclerosis
연구 개요
상세 설명
【 Objective 】 To elucide the key brain network nodes and their brain mechanisms of language cognitive impairment and decline in ALS, and to reveal the neural mechanism of the association between language cognitive impairment and motor executive function in ALS, so as to provide potential early diagnostic markers and targeted therapeutic targets for language cognitive impairment in ALS.
[Design] With the help of multi-modal brain imaging methods such as resting-state functional MRI, task-state functional MRI, structural MRI and diffusion tensor imaging, this project will analyze from multiple dimensions such as brain structure, gray matter morphology, white matter fibrous brain functional activation mode and brain functional connectivity network.
In particular, combined with the brain functional activities of ALS patients in the cognitive processing task of language understanding and language use, the brain network damage of ALS patients in motor and executive function was compared, and the neural activities and network mechanism of specific changes in language cognitive processing in ALS patients were investigated. Combined with the clinical neuropsychological behavior evaluation data, To deeply understand the neural mechanism of language cognitive impairment in ALS patients.
The research will be divided into four parts, including: the brain functional network mechanism of ALS language understanding processing injury, ALS language use processing injury, ALS motor executive processing injury, ALS language cognitive injury brain structural network mechanism.
Ten patients with ALS were included in each part of the study, and 40 patients with ALS in four parts were included in the study. Multimodal magnetic resonance scanning and cognitive assessment were performed.
Normal healthy controls for this study will be provided by the research team of Peking University Magnetic Resonance Imaging Research Center of this project group.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Beijing, 중국
- Peking Yniversity Third Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
(I) Study population
1. Inclusion criteria:
- Satisfied clinically possible ALS, laboratory supported suspected ALS, clinically suspected ALS or clinically confirmed ALS in the diagnostic criteria of ALS EL Escorial revised in 1998
- Ages 18-70
- Agree and sign the informed consent
2. Exclusion criteria:
- Severe respiratory dysfunction, unable to cooperate with NMR examination
- Severe dysarthria and limb dysfunction, unable to cooperate with the neuropsychological examination
- Patients with absolute or relative contraindications to MRI, including: a) Patients with cardiac pacemakers, cochlear implants, built-in pumps, nerve stimulators, artificial metal heart valves, etc.; B) After ligation of aneurysm clip (except non-paramagnetic, such as titanium alloy); C) Internal ferromagnetic metal implants (excluding metal IUD and fixed dentures); D) Claustrophobic; E) Patients with epilepsy
- Pregnant patients
- illiterate
설명
Inclusion Criteria:
Entry criteria:
- Satisfied clinically possible ALS, laboratory supported suspected ALS, clinically suspected ALS or clinically confirmed ALS in the diagnostic criteria of ALS EL Escorial revised in 1998
- Ages 18-70
- Agree and sign the informed consent
Exclusion Criteria:
- 1) Severe respiratory dysfunction, unable to cooperate with NMR examination 2) Severe dysarthria and limb dysfunction, unable to cooperate with the neuropsychological examination 3) Patients with absolute or relative contraindications to MRI, including: a) Patients with cardiac pacemakers, cochlear implants, built-in pumps, nerve stimulators, artificial metal heart valves, etc.; B) After ligation of aneurysm clip (except non-paramagnetic, such as titanium alloy); C) Internal ferromagnetic metal implants (excluding metal IUD and fixed dentures); D) Claustrophobic; E) Patients with epilepsy 4) Pregnant patients 5) illiterate
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
impaired speech comprehension processing in ALS
Brain functional network mechanism of impaired speech comprehension processing in ALS
|
In this project, multi-modal brain imaging methods, such as resting-state functional MRI, task-state functional MRI, structural MRI and diffusion tensor imaging, will be used to analyze brain structure, gray matter morphology, white matter fibrous brain functional activation mode and brain functional connectivity network, and other dimensions. In particular, combined with the brain functional activities of ALS patients in the cognitive processing task of language understanding and language use, the brain network damage of ALS patients in motor and executive function was compared, and the neural activities and network mechanism of specific changes in language cognitive processing in ALS patients were investigated. Combined with the clinical neuropsychological behavior evaluation data |
|
language use processing injury in ALS
Brain functional network mechanism of language use processing injury in ALS
|
In this project, multi-modal brain imaging methods, such as resting-state functional MRI, task-state functional MRI, structural MRI and diffusion tensor imaging, will be used to analyze brain structure, gray matter morphology, white matter fibrous brain functional activation mode and brain functional connectivity network, and other dimensions. In particular, combined with the brain functional activities of ALS patients in the cognitive processing task of language understanding and language use, the brain network damage of ALS patients in motor and executive function was compared, and the neural activities and network mechanism of specific changes in language cognitive processing in ALS patients were investigated. Combined with the clinical neuropsychological behavior evaluation data |
|
motor executive processing injury in ALS
Brain functional network mechanism of motor executive processing injury in ALS
|
In this project, multi-modal brain imaging methods, such as resting-state functional MRI, task-state functional MRI, structural MRI and diffusion tensor imaging, will be used to analyze brain structure, gray matter morphology, white matter fibrous brain functional activation mode and brain functional connectivity network, and other dimensions. In particular, combined with the brain functional activities of ALS patients in the cognitive processing task of language understanding and language use, the brain network damage of ALS patients in motor and executive function was compared, and the neural activities and network mechanism of specific changes in language cognitive processing in ALS patients were investigated. Combined with the clinical neuropsychological behavior evaluation data |
|
anguage cognitive impairment in ALS
Brain structural network mechanism of language cognitive impairment in ALS
|
In this project, multi-modal brain imaging methods, such as resting-state functional MRI, task-state functional MRI, structural MRI and diffusion tensor imaging, will be used to analyze brain structure, gray matter morphology, white matter fibrous brain functional activation mode and brain functional connectivity network, and other dimensions. In particular, combined with the brain functional activities of ALS patients in the cognitive processing task of language understanding and language use, the brain network damage of ALS patients in motor and executive function was compared, and the neural activities and network mechanism of specific changes in language cognitive processing in ALS patients were investigated. Combined with the clinical neuropsychological behavior evaluation data |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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ALSFRS-R score
기간: After 1 year of recruitment
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Amyotrophic lateral sclerosis rating scale
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After 1 year of recruitment
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공동 작업자 및 조사자
수사관
- 연구 의자: Shan Ye, Peking Yniversity Third Hospital Medical
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .