Effect of Transcutaneous Electrical Auricular Stimulation of the Vagus Nerve in Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Levels of blood inflammatory cytokines in kidney transplant recipients after transcutaneous auricular electrical vagus nerve stimulation.
研究概览
简要总结
Kidney transplantation entails the implantation of a live or deceased organ into a recipient. As a result of this event, there is an inflammatory response in the recipient elicited by the transplanted organ.
At the present time, immunosuppressive treatments are routinely used to avoid rejection of the transplanted organ. Although effective in this goal, there is currently an unmet need to develop new strategies to control the innate inflammatory responses and to reduce the injury caused to the organs being transplanted.
The investigators propose a novel approach to the management of this inflammatory response. The investigators will explore the "cholinergic anti-inflammatory pathway" as a potential target, a pathway first characterized in the basic science laboratories of the Feinstein Institute for Medical Research. In short, the vagus nerve activates the splenic nerve which activates choline acetyltransferase expressing T cells in the spleen. Stimulation of the alpha7 nicotinic acetylcholine receptor (alpha7nAChR) on macrophages by acetylcholine reduces production of multiple pro-inflammatory cytokines.
Currently, vagus nerve stimulation is used to treat a number of human diseases, including epilepsy, depression and migraine headaches. Many of these treatments activate the vagus nerve non-invasively by stimulating a branch of the vagus that innervates the ear. In this study, the investigators will stimulate this branch of the vagus nerve, and look for changes in inflammatory markers in the blood of kidney transplant recipients of both live and deceased donors.
Successful completion of this study will allow for future studies in organ transplant recipients.
详细描述
Intervention and comparators:
Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes in the OR already under anesthesia. Subjects will be blinded to their treatment arm.
The device to be used will include a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin overlying the cymba conchae of the ear canal.
Anatomical landmarks and cutaneous innervation of the external ear. Three nerves contribute to the cutaneous innervation of the lateral aspect of the ear: the auricular branch of the vagus nerve (ABVN), the auriculotemporal nerve (ATN) and the great auricular nerve (GAN). There is a variable degree of overlap in the distribution of these cutaneous nerves.
Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch. The handheld electrical pulse generator (e.g. Roscoe Medical, TENS 7000) will be programmed to deliver stimulation pulses to the electrodes. The electrodes will be made of conductive material facilitating trans-cutaneous electrical stimulation. All subjects will be told that they may or may not sense the stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
A randomization schema will be generated by the BU-FIMR by study strata (recipients of a kidney from a living donor and recipients of a kidney from a deceased donor) using the method of permuted blocks. For those receiving their kidneys from living donors, subjects will be randomly assigned in a 1:1 ratio to either 'aVNS' or 'sVNS. For those receiving their kidneys from deceased donors, subjects will also be randomly assigned in a 1:1 ratio to either 'aVNS' or 'sVNS'. Details of the randomization procedure, including required record keeping will be further developed upon approval of the protocol.
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
- •Kidney transplant recipients of both live and deceased donors
排除标准
- •Refusal to participate in the study
结局指标
主要结局
Levels of blood inflammatory cytokines in kidney transplant recipients after transcutaneous auricular electrical vagus nerve stimulation.
时间窗: 24 months
The present study will measure systemic cytokines IL-1, IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, IL-17, IL-22, IL-23, TNF, IFN-gamma, HMGB1, TGF-beta, GM-CSF, CXCL8, G-CSFas well as complement 1-9 in the blood of kidney transplant recipients who have undergone transcutaneous auricular electrical vagus nerve stimulation.
次要结局
未报告次要终点