Investigating the Tolerability and Feasibility of Transcutaneous Vagus Nerve Stimulation Following Aneurysmal Subarachnoid Haemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Monitor tolerability for tVNS
研究概览
简要总结
After a subarachnoid haemorrhage, complications are common and increase the overall rate of disability and death from the condition. Despite some advances in preventing, detecting and treating these complications, the rates of complications and associated risks remain high. Further research into ways to reduce complications of subarachnoid haemorrhage.
Transcutaneous vagus nerve stimulation (tVNS) is a technique where a small handheld device is attached to an earpiece which stimulates the nerves to the ear. This is given for short periods and may help improve blood flow and reduce inflammation in the brain. The intervention has been safely used and licensed in seizures, headache and severe depression.
This study will look to see if it is feasible and tolerable to have tVNS twice daily for 5 days after subarachnoid haemorrhage, and whether it can help reduce the risk of complications from subarachnoid haemorrhage.
The participant will be randomly allocated to receive either tVNS or a dummy intervention, known as sham.
The researchers will collect some personal and clinical details such as diagnosis, medications, age, blood test results, as well as some details about the subarachnoid haemorrhage.
The researchers will also complete brief questionnaires with the participant to assess symptoms. They will take measurements of heart rate, pupil response, and brain activity using a cap. The participant will then be randomly allocated to either receive the tVNS or sham intervention.
Next, the research team will apply the earpiece to their ear twice a day for 45 minutes, for a total of 5 days.
At the end of the 5-day study period, the intervention will be complete. The researchers will arrange a follow-up meeting on discharge and at 6 weeks, to assess the participants symptoms and recovery.
Previous studies have shown that tVNS is safe and well tolerated, including a recent review of tVNS studies which evaluated the side effects experienced by 1322 patients receiving tVNS.
The main side effects include localised tingling/numbness/pain/redness around the ear (17%), headaches (3%), dizziness (1%), facial droop (1%), nausea (1%), nasal discharge (2%). Rarely, palpitations or a slow heart rate may occur.
They will continue to receive full medical treatment and observation alongside the study. They are free to withdraw from this study if they find it too demanding on top of their other activities.
详细描述
The aims of the study will be to conduct a pilot RCT to investigate whether tVNS is a tolerable and feasible treatment for acute aSAH. To understand this the investigators will recruit participants who have recently undergone acute securing procedures follow acute aSAH (coiling or clipping of aneurysm) to a 5 day programme of intervention (active tVNS vs sham) and collect outcome data (primary and secondary as per outcomes section). The investigators will evaluate whether pre-defined success criteria are achieved for tolerability and feasibility and explore signals of effect on clinical outcome measures and mechanistic measures. Non-invasive vagal nerve stimulation has not been studied in the acute period following aSAH outside of the remit of reducing headache. This should offer critical insights as to whether this intervention has potential to take forward to a larger phase 2/3 clinical study.
This is a single centre, pilot, randomised controlled trial. 30 participants who have suffered an aneurysmal subarachnoid haemorrhage and had their aneurysm secured (coiled or clipped successfully).
The intervention will take place for 45 minutes twice a day for 5 days after securing the aneurysm. The placebo group will receive the same intervention, but the device will be in 'sham' mode (i.e. attached to the earlobe).
It is not known whether tVNS is tolerable, and feasible in aSAH, but standard device settings will be used in accordance with a majority of other studies. Similarly, the optimal therapeutic duration is not known - 45 minutes twice a day is a similar usage to other studies. A 5-day course has been chosen because it covers the highest risk period for DCI and is feasible for the research team to deliver.
This is a single centre pilot, single blind, randomised, placebo - controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Age >18
- •Admitted to STH (Sheffield Teaching Hospital) neurosurgery department
- •Confirmed aneurysmal SAH on vascular imaging
- •Within 5 days of 'Securing' aneurysm (i.e., successfully coiled or surgically following rupture)
排除标准
- •Current or prior use of a vagus nerve stimulation
- •Symptomatic bradycardia or PPM insertion
- •Complete heart block
- •Implantation of any other electrical stimulator (e.g. DBS)
结局指标
主要结局
Monitor tolerability for tVNS
时间窗: 4 weeks
Symptom severity scores of mild or moderate in less than 1/3 of participants able to report symptoms
Assess study feasibility
时间窗: 24 months
recruit \>1 patient per month of recruitment, and \>80% of recruited patients completing primary outcome measures
次要结局
- Headache scores(4 weeks)
- Heart rate variability(Baseline and 5 days)
- Monitor safety criteria for tVNS(4 weeks)
- Rates of delayed cerebral ischaemia (DCI)(4 weeks)
- Inpatient mortality(4 weeks)
- Length of inpatient stay(From the date of admission to the date of discharge from hospital up to 100 months)
- Rates of inpatient complications(From the date of admission to the date of discharge from hospital up to 100 months)
- Modified rankin score(4 weeks)
- Barthel Index(4 weeks)
- Inflammatory markers(Baseline and end of intervention (day 5))
- Cerebral functional near-infrared spectroscopy(Baseline and 5 days)
- Pupillary light reactivity(Baseline and 5 days)