Structural and Functional Connectivity as Outcome Markers of Cranioplasty Following Decompressive Craniectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in Mean Diffusivity values:
研究概览
简要总结
An Exploratory Interventional study to assess the effects of cranioplasty on brain network connectivity, neuropsychological and motor functioning in patients with severe acquired brain injury with pre-, post-cranioplasty and 6 months follow-up assessments.
详细描述
BACKGROUND: Cranioplasty (CP) refers to the surgical reconstruction of the cranial defect secondary to Decompressive Craniectomy (DC). The aim of this intervention is not only to restore cranial cosmesis and the normal cerebral protection, but also to facilitate neurological rehabilitation.
Clinical improvements after CP, may occur as early as 4 days after the surgical reconstruction of the cranial vault and may include vigilance/consciousness, sensorimotor and cognitive functioning. In particular, several studies showed relevant neurological improvement of motor and cognitive impairments as well as in the disability level in severe acquired brain injury (sABI) patients treated with DC in the acute phase. To date, it is not possible to predict the extent of the expected improvement after CP, and the effects in terms of long-term functional outcome appears to be variable from subject to subject.
The CO-CRAN (COnnectivity in CRANioplasty) study is based on the experimental hypothesis that the extent of recovery could be significantly correlated with the degree of integrity of the neural network, in relation to the primary damage, of the cerebral hemisphere ipsilateral to craniectomy. It is assumed that if the neural network is relatively intact, the extent of the recovery could be maximal. Conversely, when there is an extensive functional impairment of the underlying craniectomy flap, the impairment of the neural network does not allow a maximum recovery.
AIM: The aim of the study is to investigate possible morpho-functional neuroimaging determinants that may be predictive of post-cranioplasty recovery in patients with sABI undergoing DC.
METHODS: Exploratory clinical trial with pre-test, post-test, and 6 months follow-up assessments. Medical drugs and device are not involved in the study. The design provides only one group of patients who underwent CP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of sABI, a neurological condition due to a severe acquired brain damage (i.e., traumatic brain injury, ischemic stroke, hemorrhagic stroke) with a coma lasting at least 24 hours, according to a Glasgow Coma Scale equal or lower than 8 and/or complex and severe neurological disabilities treatable only in high specialty neurehabilitative settings.
- •Early DC, within 24 h;
- •Age between 18 and 75 years;
- •Intra-hospital rehabilitation setting (ordinary hospitalization or day hospithal);
- •Informed consent agreement.
排除标准
- •Medical instability at enrollment, defined as the acute onset of an unexplained derangement of vital parameters (i.e., temperature, blood pressure, pulse rate, respiratory rate, oxygen saturation, level of responsiveness) outside the normal range (for example, fever, acute internist conditions, etc.) and/or the onset of any new medical condition requiring unexpected additional diagnostic procedures and treatments (for example, severe pain, reduction of urinary output, etc.);
- •Post-traumatic agitation;
- •Dehiscence, in progress, of the DC surgical wound;
- •CP already performed;
- •Magnetic Resonance Imaging (MRI) absolute contraindications.
研究组 & 干预措施
CP group
Pre- post-cranioplasty and 6 months follow-up MRI assessment. Each MRI session lasts about 60 minutes and will measure Diffusion Tensor Imaging, Tractography and resting state fMRI
干预措施: CP group (Procedure)
结局指标
主要结局
Changes in Mean Diffusivity values:
时间窗: pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP
- Mean diffusivity (MD) from the Diffusion Tensor Imaging (DTI) data: a measure of brain structural integrity which describes the rotationally invariant magnitude of water diffusion within brain tissues. Higher values indicate worse tissue injury.
次要结局
- Changes in motor autonomy(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in Ambulation(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in Cognitive functioning(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in disability level(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in functional independence(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in level of consciousness(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in walking abilities(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in motor abilities(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in EEG connectivity and continuity(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in trunk control(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in quantitative EEG(Frame: pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in fractional anisotropy values(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in functional abilities(Frame: pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in cognitive level(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in neuropsychological functions(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in Structured neuropsychological assessment(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in balance control(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)
- Changes in walking handicap(pre-test: within 10 days before CP - post-test: from 30 to 40 days after CP - follow-up: from 170 to 190 days after CP)