2021年12月14日

2021年12月14日10:10am缺血性中風係統的植入電極提供電刺激神經的鼻子一天幾次,目的是增加腦血流量在急性缺血性中風。(FDA)近兩年BrainsGate後提交了FDA批準上市前的植入式神經刺激器,一個顧問小組的機構達成了一項重大打擊以色列公司的計劃。缺血性中風係統的電極植入口腔內部,他們提供電刺激一天幾次蝶齶骨的神經節,鼻子和背後的一群神經細胞位於與疼痛和其他感官體驗。設備旨在促進急性缺血性中風後血液流向大腦。在一次會議上,橫跨幾個小時12月10日,美國食品藥品監督管理局的專家小組的神經係統設備討論一些問題與缺血性中風的性能係統,或國際空間站,BrainsGate-sponsored臨床與研究本身的參數研究。最終,盡管專家組一致同意的安全係統,絕大多數都無法肯定它是一個有效的治療中風和它的好處大於風險。而谘詢委員會投票法案僅作為一個不具約束力的建議FDA的決定是否批準許可,一個設備或藥物,該機構兩邊的麵板在絕大多數情況下,瘦身BrainsGate獲得批準國際空間站的機會。會議之前,美國食品和藥物管理局列出了問題(PDF)的臨床試驗的結果。試驗旨在證明當係統植入在24小時內發病,與刺激在四個小時會議申請五天,中風後殘疾將降至三個月。許多研究機構的關注源於本身。 For one, 12% of patients enrolled in the study had to be excluded from the treatment group because the stimulator couldn’t be implanted or didn’t correctly administer stimulation. Meanwhile, none of the participants in the sham group had to be excluded, an imbalance the FDA said “raises serious doubts about the results of the study.” Other issues raised by the FDA questioned the study’s overall measure of effectiveness. Success in the trial was measured by comparing patients’ disability ratings to a predictive model derived from previous trial data, which the agency said contained an “unexpected degree of inaccuracy.” Additionally, the trial’s protocol, statistical analysis plan, primary outcome and even the device used were changed after the study had already begun, all of which can increase uncertainty in a study’s results. In another of its listed discussion points, the FDA said it was “concerned about the risk associated with direct and indirect consequences of implantation of the device,” which it feared may have been underrepresented in the study results. Potential side effects include airway endangerment, laryngospasm, microaspiration and chronic neuropathic pain caused by the process of puncturing the roof of the mouth to implant the device as well as risks of hemorrhagic transformation, brain swelling, hematoma formation, a spike in blood pressure, infection at the implantation site and more—none of which were reported in the clinical trials.