NCT06614400已完成不适用
MonitoRing the Effect of TRAnscutaneous Functional electrIcal Stimulation of the Common Peroneal Nerve on Cerebral Haemodynamics in Patients With Ischaemic Strokes. A Single Centre Prospective Study (Phase 1).
Countess of Chester NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年10月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Primary outcome
研究概览
简要总结
The primary objective is to investigate in stroke patients the impact of geko™ NMES treatment, when used as standard of care for VTE prevention, on brain haemodynamics at different stimulation levels and in three different postural positions (supine, semi-supine [45° seated] and seated). The aim is to identify the optimal stimulation level and postural position for the maximum response (NMES versus no NMES) with regard to relative total haemoglobin concentration (i.e., the sum of relative deoxyhaemoglobin and oxyhaemoglobin concentrations) using fNIRS and EEG.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult over 18
- •Patient with ischaemic stroke diagnosis confirmed by a stroke physician.
- •No intracerebral haemorrhage as ruled out by computerised tomography (CT) or MRI scan.
- •Able to achieve a supine, sitting and semi-sitting position of 45° with the help of another person.
- •Receiving geko™ NMES treatment as standard of care for VTE prevention
排除标准
- •Inability to gain consent from the patient.
- •A transient ischaemic attack (TIA).
- •Stroke survivors with ischaemic stroke less than 7 days from onset.
- •History of epilepsy.
- •Below/above knee amputation.
- •History of established peripheral neuropathy.
- •Too unwell to participate as judged by physician.
- •Use of any other neuromodulation device that may interact with NMES
结局指标
主要结局
Primary outcome
时间窗: 3 hours
a change in brain haemodynamics (or blood flow) in terms of oxygenated and de-oxygentated blood from baseline to end of study participation.
次要结局
- Secondary objective(3 hours)
研究者
研究点 (1)
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