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临床试验/CTRI/2024/08/072873
CTRI/2024/08/072873招募中不适用

Quantification of Ischemic Lesion using Intravoxel Incoherent Motion and prediction of Motor Outcome with Diffusion Kurtosis Imaging in Acute Stroke

Manipal College of Health Professions1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2024年9月2日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
176
试验地点
1
主要终点
phase 1

研究概览

简要总结

Objectives

Phase 1

To assess the utility of the hybrid IVIM sequence to differentiate the ischemic core from the penumbra

To determine the association between the IVIM parameters and stroke severity

Phase 2

To analyze whether DKI parameters predict motor outcomes 1 and 3 months after acute ischemic stroke

To compare the DKI parameters in the lesioned and the contralateral hemispheres along the pathway in the brain

Procedure

Phase 1

The thoroughly signed informed consent from the patient, if conscious, if not from the patient’s legal guardian, and later, once the patient is stable, the patient’s signature will also be obtained. Those who meet the inclusion criteria will undergo an MRI brain-stroke protocol. The IVIM raw data will be post-processed using in-built software to acquire parametric maps for relative Cerebral blood flow (rCBF), Diffusion Coefficient (D), pseudo-diffusion coefficient (D*), and perfusion fraction (f). An ellipse ROI will be placed in the core. A symmetrical ROI will be placed in the contralateral normal hemisphere of the brain, and the third ROI will be placed in the penumbra. The numerical values obtained as Mean ± SD will then be tabulated. The baseline NIHSS score will be noted.

Phase 2

Those fitting the inclusion criteria will undergo the MRI brain stroke protocol after signing an informed consent. The obtained DKI raw data will be post-processed using the Diffusion analysis software. Ellipse ROI will be placed in the following regions of the affected as well as the contralateral hemisphere: ischemic lesion, precentral gyrus, supplementary motor area, post-central gyrus, Posterior Limb of Internal Capsule, corona radiata, corpus callosum, and perilesional white matter. The parametric values from each Mean Diffusivity (MD), Fractional Anisotropy (FA), Mean Kurtosis (MK), Radial Kurtosis (RK), Axial Kurtosis (AK), and Kurtosis Anisotropy (KA) will be obtained for all the ROIs. A physiotherapist will evaluate the baseline Fugl Meyer assessment (FMA) score for the upper and lower limbs. When the patient arrives for the standard 1-month follow-up, the FMA score will be noted. At 3rd month follow-up FMA score will again be noted.

Significance of the study

This study will aid in the early detection of salvageable tissue in cases of acute ischemic stroke, which then, if treated immediately, will prevent the further deterioration of tissue that would otherwise lead to catastrophic complications. It will also aid in determining the amount of motor damage already caused in the acute setting, thereby enabling appropriate treatment and rehabilitation measures to be taken accordingly, leading to a better prognosis.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Phase 1 Patients with first ever stroke and early stroke symptoms like Upper or lower limb weakness slurring of speech or blurring of vision Time between the onset of symptoms and MRI scan less than 24 hours Phase 2 1 Unilateral first-ever stroke occurred due to middle cerebral artery occlusion.

排除标准

  • Phase 1 Presence of any hemorrhage traumatic or space-occupying lesion in the brain Ischemic lesions smaller than 0.5 cm Those having a non-penumbra core on imaging Phase 2 Multiple Focal infarcts Patients with a history of motor disability due to other underlying causes.

结局指标

主要结局

phase 1

时间窗: baseline, 1 and 3 months after stroke

IVIM parameters and NIHSS score

时间窗: baseline, 1 and 3 months after stroke

Phase 2

时间窗: baseline, 1 and 3 months after stroke

DKI parameters and Fugl-Meyer assessment score at baseline, 1 and 3 months after stroke

时间窗: baseline, 1 and 3 months after stroke

次要结局

  • NA(NIL)

研究者

发起方
Manipal College of Health Professions
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Tancia Pires

Manipal College of Health Professions

研究点 (1)

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