Magnetic Resonance Imaging of Cerebral Connectivity and Volume in Neurodegeneration and Glaucoma (EVOLUTION)
調査の概要
詳細な説明
Glaucoma is a neurodegenerative disease characterised by a progressive loss of retinal ganglion cells, typical optic neuropathy with a loss of visual field and visual function. High intraocular pressure is it's main risk factor, but the patophysiology hasn't been clearely understood, as there exist forms with normal ocular pressure (NTG - normal tension glaucoma) or mixed forms. Studies have shown that the degeneration is not limited to retinal ganglion cells only, but rather it affects the whole visual pathway including the occipital cortex. The ENVOL study has been able to show microstructural alterations of the optic radiations in glaucoma. Furthermore, glaucomatous patients have been found to be more at risk of developing other neurodegenerative diseases, namely Alzheimer's disease.
The EVOLUTION study is set to repeat 3T brain MRI in patients previously enrolled in ENVOL in order to compare brain microstructure between glaucomatous and matched healthy subjects, assess their ocular status and glaucoma progression over time, as well as compare them with orignal imagery from 10 years prior.
gression over time, as well as compare them with orignal imagery from 10 years prior.
Study subjects will undergo a typical non-invasive ophthalmic screening comprised of best-corrected visual acuity testing, slit-lamp biomicroscopy, gonioscopy, indirect opthalmoscopy, fundus photography, 30° visual field testing and optical coherence tomography of the optic nerve. They will also answer a questionnaire concerning their medical treatment, cardiovascular health and tobacco use. Next, they will undergo a 3T brain MRI comprised of a T1-weighted 3D morphological sequence, 3D FLAIR, resting state fMRI and diffusion tensor imaging.
fMRI and diffusion tensor imaging
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Cedrick Schweitzer, MD, PhD
- 電話番号：+335 56 79 55 30
- メール：cedric.schweitzer@chu-bordeaux.fr
研究場所
-
-
-
Bordeaux、フランス
- 募集
- CHU Bordeaux
-
コンタクト：
- Cedrick Schweitzer, MD, PhD
- 電話番号：+335 56 79 55 30
- メール：cedric.schweitzer@chu-bordeaux.fr
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- having been previously included and completed the ENVOL study
- Ability and willingness to provide informed consent
- Having a valid health insurance in France
In glaucoma group :
- Glaucomatous optic neuropathy, being able to be graded by the vertical C/D ratio
- Open angle on gonioscopy in a dark-room testing according to Shaffer's classification (grade 3 or grade 4)
Visual field impairement (at least one of the following) :
- 3 adjacent points with at least 5dB loss
- one point with a loss of 10dB
- a difference of at least 10 dB for 2 adjacent points on either side of the horizontal meridian of the nasal visual field
- Mini Mental State Score of at least 28
In control group :
- No personal or family history of glaucoma or ocular hypertension (IOP > 21 mmHg)
- Open angle on gonioscopy in a dark-room testing according to Shaffer's classification (grade 3 or grade 4)
- Intraocular pressure of ≤ 21 mmHg
- Absence of glaucomatous neuropathy
- Normal visual field
Exclusion Criteria:
- Inability/unwillingness to provide informed consent
- Other causes of ocular hypertension (trauma, uveitis)
- Non-glaucomatous optic neuropathy (infectious, inflammatory, compressive, ischemic)
- Unreliable visual field (>15% false positives, >33% false negatives or >20% loss of fixation)
- Severe corneal pathology preventing access to fundus, visual field testing or altering ocular tonometry
- Contraindications to MRI testing (pacemakers or neurosensory stimulators, cochlear implants, ferromagnetic foreign bodies, claustrophobia)
- Patients under guardianship or other form of legal protection
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
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Patient with glaucoma
|
MRI
|
|
アクティブコンパレータ：Patient without glaucoma
|
MRI
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
structural and functional connectivity matrices
時間枠：Baseline
|
10-year whole brain comparison of structural and functional connectivity matrices (Hub Disruption Index) on 3T MRI in glaucoma patients and controls from the ENVOL study
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Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
microstructural changes
時間枠：Baseline
|
Comparison of microstructural changes on diffusion MRI within the whole brain and by specific regions (white matter, gray matter, hippocampus, amygdala, occipital cortex) between the 2 groups (voxel-by-voxel analysis)
|
Baseline
|
|
cerebral volumes
時間枠：Baseline
|
Comparison of cerebral volumes (total volume of cerebral parenchyma), and volumes of specific regions (white matter, gray matter, hippocampus, amygdala, occipital cortex) between the 2 groups
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Baseline
|
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Evolution of the above parameters
時間枠：Baseline
|
Comparison of evolution of the above parameters over a 10-year period between the ENVOL study and EVOLUTION follow-up study (microstructural changes on diffusion MRI within the whole brain and by specific regions (white matter, gray matter, hippocampus, amygdala, occipital cortex), cerebral volumes (total volume of cerebral parenchyma), and volumes of specific regions (white matter, gray matter, hippocampus, amygdala, occipital cortex)).
|
Baseline
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Demographic factors
時間枠：Baseline
|
Identication of demographic that could be associated with overall degenerative impairment as measured in the primary objective and secondary objectives above
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Baseline
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Ophthalmological factors
時間枠：Baseline
|
Ophthalmological factors, notably characterization of the type of glaucoma (normal pressure, high pressure) that could be associated with overall degenerative impairment as measured in the primary objective and secondary objectives above
|
Baseline
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- CHUBX 2024/90
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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