- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07720206
Abnormality of the Central Canal of the Spinal Cord in Syringomyelia in a Patient With a Basal Skull Malformation (SYRCANAL)
The aim of this study is to analyze the association between a deformity of the cranial portion of the central spinal canal and syringomyelia in patients with a Chiari-type malformation of the craniocervical junction.
The investigators hypothesize that Chiari malformation, defined by the herniation of the cerebellar tonsils through the foramen magnum, may be responsible for a deformation of the cranial portion of the central spinal canal, and that this deformation is associated with the presence of syringomyelia in patients with this malformation.
연구 개요
상세 설명
Chiari Malformation Type I (CM-I) is a congenital anomaly characterized by downward displacement of the cerebellar tonsils through the foramen magnum, which may disrupt cerebrospinal fluid (CSF) circulation at the craniovertebral junction. The condition generally results from underdevelopment of the posterior cranial fossa, leading to insufficient space for the cerebellum. This anatomical abnormality can cause a wide range of heterogeneous symptoms, including occipital headaches triggered by coughing or exertion, neck pain, dizziness, balance disturbances, paresthesia, limb weakness, and swallowing difficulties.
One of the most concerning complications is syringomyelia/hydromyelia, which corresponds to the development of fluid-filled cavities within the spinal cord. These cavities may either be adjacent to the central canal (syringomyelia) or result from dilation of the central canal itself (hydromyelia). Associated spinal cord involvement may lead to specific neurological symptoms and is often a major indication for surgical treatment of Chiari malformation.
The decision to perform surgical decompression of the craniovertebral junction must balance the potential benefits against the associated risks. Furthermore, surgical outcomes remain variable and sometimes uncertain. Some symptoms may persist despite surgery, and syringomyelia regression is inconsistent. A better understanding of the pathophysiology of syringomyelia associated with Chiari malformation is therefore essential to improve patient selection and optimize surgical strategies.
Although the pathophysiology of syringomyelia in Chiari malformation has been investigated in several studies, it remains only partially understood. Recently, the position of the obex has been suggested to be associated with the presence of syringomyelia in patients with Chiari malformation. The obex is the neurological structure located at the cranial end of the central canal. Based on previous findings, investigators hypothesize that a low-lying obex may induce deformation of the central canal, creating a folding or kinking effect that could explain downstream canal dilation. Our primary hypothesis is therefore that the morphology of the central canal at the cervicomedullary junction (including angulation, folding, or compression) is a key factor influencing the presence or absence of associated hydromyelia/syringomyelia and, consequently, clinical severity.
Animal studies support a pathophysiological cascade involving initial mechanical deformation of the central canal followed by pericanal inflammation contributing to syringomyelia formation. According to this novel hypothesis, cerebellar tonsillar descent without associated central canal deformation would confer a lower risk of syringomyelia and unfavorable clinical progression than cases involving deformation of the cranial portion of the central canal.
In vivo visualization and morphological assessment of the cranial portion of the ependymal central canal using MRI therefore offer the potential to identify new risk markers for Chiari malformation that may ultimately assist surgical decision-making. However, when the canal is not dilated, visualization remains challenging, as does the identification of potential pericanal inflammation.
Several years ago, Tourdias et al. developed a specific MRI sequence known as White Matter-nulled (WMn) MPRAGE, which enhances contrast between structures of the central nervous system, including the thalamus, thereby improving the accuracy of thalamic assessment in pathological conditions. More recently, this group demonstrated that the WMn-MPRAGE sequence can be adapted for spinal cord imaging, maximizing the detection of spinal cord lesions. In collaboration with the Anatomy Laboratory of the University of Bordeaux, it was demonstrated that WMn-MPRAGE enables reliable visualization of the spinal cord central canal in healthy subjects when compared with previous anatomical specimen studies. Furthermore, recent advances in spinal cord diffusion MRI, particularly through artificial intelligence-based denoising methods, now enable detailed assessment of spinal cord microstructure and may allow quantification of biomarkers associated with pericanal inflammation.
Thus, the pathophysiology of Chiari Malformation Type I remains incompletely understood. Investigators hypothesize that analysis of the morphology of the cranial portion of the ependymal central canal using WMn-MPRAGE imaging, combined with assessment of the adjacent spinal cord microstructure, may provide novel biomarkers of associated syringomyelia risk and clinical severity.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jean-Rodolphe VIGNES, Pr
- 전화번호: +33 05 57 95 54 43
- 이메일: jean-rodolphe.vignes@chu-bordeaux.fr
연구 연락처 백업
- 이름: Paul ROBLOT, Dr
- 전화번호: +33 05 56 79 55 43
- 이메일: paul.roblot@chu-bordeaux.fr
연구 장소
-
-
-
Bordeaux, 프랑스
- Bordeaux University Hospital
-
연락하다:
- Jean-Rodolphe VIGNES, PR
- 전화번호: +33 05 56 79 55 43
- 이메일: jean-rodolphe.vignes@chu-bordeaux.fr
-
수석 연구원:
- Jean-Rodolphe VIGNES, Pr
-
부수사관:
- Paul ROBLOT, Dr
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adult patients being treated for Chiari malformation or syringomyelia at Bordeaux University Hospital
- Patients admitted for an initial surgical consultation regarding Chiari malformation with or without syringomyelia at Bordeaux University Hospital
- Individuals enrolled in or covered by a social security program.
- Free, informed, and express consent (confirmed in writing) (no later than the day of enrollment and prior to any examination required by the study).
Exclusion Criteria:
- Pregnant or breastfeeding patients
- Contraindications to MRI
- Individuals deprived of their liberty by judicial or administrative order,
- Adults subject to legal protective measures (guardianship, conservatorship, judicial protection).
- Patients who have previously undergone surgery for a Chiari malformation or a posterior fossa malformation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Patients with Chiari malformation with associated syringomyelia
|
Magnetic Resonance Imaging (MRI) using T1, T2, White-Matter nulled (WMn), and diffusion sequences
|
|
실험적: Patients with Chiari malformation without associated syringomyelia
|
Magnetic Resonance Imaging (MRI) using T1, T2, White-Matter nulled (WMn), and diffusion sequences
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Deformation of the central canal of the spinal cord
기간: At inclusion (D0)
|
The central canal deformation index of the spinal cord, calculated based on the angle of the curves and the length of each segment between two curves.
|
At inclusion (D0)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Protrusion of the cerebellar tonsils
기간: at inclusion (day 0)
|
Protrusion of the cerebellar tonsils into the foramen magnum on T2-weighted MRI. Commonly accepted definition of Chiari malformation Type I: cerebellar tonsils extending more than 5 mm below the McRae line on MRI. The McRae line is defined as the anatomical line connecting the basion and the opisthion, corresponding to the anterior and posterior margins of the foramen magnum. |
at inclusion (day 0)
|
|
Presence and dimensions of syringomyelia
기간: At inclusion (day 0)
|
The presence and dimensions of syringomyelia on MRI using T2 and WMn-MPRAGE sequences
|
At inclusion (day 0)
|
|
Distance between the obex and the foramen magnum
기간: At inclusion (Day 0)
|
Distance between the obex and the foramen magnum on T2-weighted and WMn-MPRAGE MRI sequences
|
At inclusion (Day 0)
|
|
Diffusion MRI parameter (1)
기간: At inclusion (Day 0)
|
Diffusion MRI parameter (mean diffusivity) in the pericanalicular region
|
At inclusion (Day 0)
|
|
Diffusion MRI parameter (2)
기간: At inclusion (Day 0)
|
Diffusion MRI (anisotropy fraction) in the pericanalicular region
|
At inclusion (Day 0)
|
공동 작업자 및 조사자
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHUBX 2026/003
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
MRI에 대한 임상 시험
-
Cambridge University Hospitals NHS Foundation Trust모병
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)종료됨
-
Assistance Publique Hopitaux De Marseille모집하지 않고 적극적으로
-
Assistance Publique - Hôpitaux de Paris알려지지 않은
-
Assistance Publique Hopitaux De Marseille완전한
-
American College of Radiology Imaging NetworkNational Cancer Institute (NCI); Eastern Cooperative Oncology Group알려지지 않은
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin완전한