- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06636994
동측 반맹증 환자의 실시 능력에 대한 해부학적 및 기능적 예측 (PRE-SIGHT)
Homonymous lateral hemianopia (HLH) is characterized by loss of vision in half the visual field, and is the most common neurovisual disorder following stroke.
Numerous behavioral and neuroanatomical studies have focused on the phenomenon of blindsight, corresponding to patients' unconscious residual visual capacities in the blind hemifield. Cohort studies of patients have highlighted different types of blindsight, and a low occurrence of the phenomenon initially described: (1) type 1 blindsight (≈12%), unconscious visual abilities; (2) type 2 blindsight, visual abilities associated with sensations in the blind field (≈18%); (3) blindsense, sensations in the blind field without visual abilities (≈30%); and (4) no blindsight (≈40%). The heterogeneity of these blindsight abilities in the HLH population is closely related to patients' neuroanatomical and functional profiles.
In particular, resting-state functional imaging (r-fMRI) and default mode network analysis have highlighted a significant correlation between the degree of inter-hemispheric connection (between the healthy and injured hemispheres) and the rate of spontaneous visual field recovery. To our knowledge, this degree of functional connectivity has not yet been studied in relation to blindsight abilities. However, this functional MRI measurement tool represents a potential predictive factor for patients' residual performance in their blindsight field, in order to assess the level of visuo-cognitive impairment and, ultimately, to adapt care.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Amelie Yavchitz, Dr
- 전화번호: 0148036454
- 이메일: ayavchitz@for.paris
연구 연락처 백업
- 이름: Sadia MEDAOURI
- 전화번호: 0148036277
- 이메일: smedaouri@for.paris
연구 장소
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Paris, 프랑스, 75019
- Hopital Fondation Adolphe de Rothschild
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연락하다:
- clementine GARRIC
- 이메일: clgarric@for.paris
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients over 18 years of age with homonymous lateral hemianopia undergoing cerebral MRI for follow-up and rehabilitation following stroke
설명
Inclusion Criteria:
- Subjects aged 18 and over
- with homonymous visual field amputation sequelae of a retrochiasmatic lesion of vascular origin (stroke), including the occipital region (primary visual cortex, optic radiations, associated occipital areas)
- Requires follow-up brain MRI as part of treatment
- Able to perform experimental tasks on computer
- Express consent to participate in the study
- Member or beneficiary of a social security scheme
Exclusion Criteria:
- Severe neuropsychological disorders (language, memory, attention, vigilance, reasoning)
- Severe ophthalmological disorders or visual acuity below 3/10 prior to stroke
- Progressive ophthalmological disorders (cataract or glaucoma) likely to bias measurements
- Major psychiatric or behavioral disorders making care impossible
- Patient benefiting from a legal protection measure
- Pregnant or breast-feeding women (declarative information)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: CROSS_SECTIONAL
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Description of resting-state functional MRI measurement of the degree of Resting State Functional Connectivity (RSFC) between left and right hemisphere regions.
기간: DAY 0
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Comparison of the degree of inter-hemispheric Resting State Functional Connectivity between the four patient groups: absence of blindsight, type I blindsight, type II blindsight and blindsense. |
DAY 0
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Correlation between inter-hemispheric functional connectivity and blindsight performance
기간: DAY 0
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Resting-state functional MRI measurement of the degree of RSFC between left and right hemisphere regions of interest. Blindsight performance assessed by measuring the sensitivity of discrimination of spatial orientation (horizontal/vertical) of lines presented in the patient's blind field (blindsight). |
DAY 0
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Density and intensity of visual and attentional default networks in each type of blindsight
기간: DAY 0
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Calculation (Graph Theory) of neural network matrices, weighted and created on the basis of correlations of activations in different brain regions during resting-state functional MRI measurement . |
DAY 0
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Blindsight performance according to the laterality of the lesion (left or right hemisphere)
기간: DAY 0
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Blindsight performance assessed by measuring the sensitivity of discrimination of spatial orientation (horizontal/vertical) of lines presented in the patient's blind field (blindsight) |
DAY 0
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Correlation between the level of inter-hemispheric functional connectivity and blindsight performance
기간: DAY 0
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Resting-state functional MRI measurement of the degree of Resting State Functional Connectivity (RSFC) between left and right hemisphere regions of interest, blindsight performance assessed by measuring the sensitivity of spatial orientation discrimination (horizontal/vertical) of lines presented in the blindsight field. |
DAY 0
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Correlation between visual default network density and intensity and blindsight performance
기간: DAY 0
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Computation (Graph Theory) of neural network matrices, weighted and created on the basis of correlations of activations of different brain regions during Resting-state functional MRI measurement. Blindsight performance assessed by measuring the sensitivity of discrimination of spatial orientation (horizontal/vertical) of lines presented in the patient's blind field (blindsight). |
DAY 0
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Correlation between lesion volume and blindsight performance
기간: DAY 0
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Blindsight performance assessed by measuring the sensitivity of spatial orientation discrimination (horizontal/vertical) of lines presented in the patient's blind field (blindsight). |
DAY 0
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공동 작업자 및 조사자
수사관
- 수석 연구원: Clémentine GARRIC, Integrative Neuroscience and Cognition Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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. .