Computational Model of SNS Using Tractography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Implanting a lead around a nerve for finer details of tissues surrounding a sacral nerve stimulation lead.
研究概览
简要总结
This study aims to obtain finer details of tissues surrounding a lead in the pelvis using a combination of high-resolution anatomical MRI sequences and diffusion tensor imaging (DTI). DTI is a non-invasive technique sometimes described as fiber tractography that enables visualization of the pathways and integrity of nerves. In this feasibility study, we plan to use DTI to assess the sacral plexus and its peripheral nerves. A model will be constructed by superimposing SNS lead from a CT scan onto the DTI imaging to map out the electrode position. It is hoped that this study will lead to a better understanding of both therapeutic and adverse stimulation effects and enable patient-specific adjustments of stimulation parameters.
详细描述
Patients who have had successful temporary SNS and awaiting permanent SNS will be approached. An assessment will be made to determine whether the patient meets the inclusion/exclusion criteria. Patients will be given a consent form to sign.
The investigators will recruit from the outpatient clinic a total of ten patients for this study.
A physical examination will be performed as per standard practice. Patients will be asked to fill in questionnaires probing the severity of faecal incontinence symptoms. Included questionnaires are ICIQ-B4, Wexner's and St Mark's.
Incontinence score (see appendix). It will also evaluate any existing pain symptoms.
The patient will undergo an MRI scan (3 Tesla) of the pelvis using sequences including anatomical sequences and diffusion tensor imaging technique for construction of sacral nerve tractography prior to permanent SNS. This will be performed at Mount Vernon Hospital over an hour: first 30 minutes for anatomical sequences and the second 30 minutes for DTI sequencing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are psychologically stable and suitable for intervention and able to provide informed consent
- •Patients with symptoms of faecal incontinence for solid or liquid stool
- •Patients who have had successful outcome from temporary SNS
- •Patients who are willing and competent to fill in questionnaires and undergo an extra CT and MRI scan during the study
排除标准
- •Patients who are claustrophobic to undertake MRI scan
- •Patients who had previous devices implanted that may be magnetically, electrically, mechanically activated or affected by MRI scan
- •Pregnant patients
- •Patients who are breastfeeding
- •Patients who are psychologically unstable and unsuitable for intervention and unable to provide informed consent
- •Patients who did not successfully pass the trial of SNS temporary SNS)
研究组 & 干预措施
MRI sequences and (DTI)
The aim of this study is to obtain finer details of tissues surrounding a lead in the pelvis using a combination of high resolution anatomical MRI sequences and diffusion tensor imaging (DTI). To do so, the patient will undergo a MRI scan (3 Tesla) of the pelvis using sequences including anatomical sequences and diffusion tensor imaging technique for construction of sacral nerve tractography prior to permanent SNS. This will be performed over an hour: first 30 minutes for anatomical sequences and the second 30 minutes for DTI sequencing.
CT scan
Three to 4 weeks after the procedure the patient will undergo a limited CT scan of the pelvis to visualise the position of the SNS lead. The scan will focus only on the sacrum, implanted lead, and rectum and will not be extended beyond this area. Imaging from this CT will be superimposed to the MRI imaging the patient had pre-operatively, and a computational simulation will be performed.
干预措施: CT scan (Radiation)
结局指标
主要结局
Implanting a lead around a nerve for finer details of tissues surrounding a sacral nerve stimulation lead.
时间窗: 12 months
Size and distance of the sacral nerves from the implanted lead measured in millimetres (mm).
次要结局
- Stimulation of the sacral nerve using computational model induced electrical current to establish therapeutic range of SNS(12 months)