Transcranial Direct Current Stimulation in Acute Ischemic Stroke Treatment - Safety and Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Primary safety outcome: the rate of symptomatic intracranial hemorrhage (SICH) in the active treatment arm compared to sham arm, and between higher and lower dose tiers.
研究概览
简要总结
This prospective interventional single center randomized sham controlled dose-escalation study will assess safety, tolerability, feasibility and potential efficacy of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion who are ineligible for endovascular therapy (EVT). Patients will be randomized in a 3:1 design, to cathodal versus sham (control) tDCS, at each six designed dose tiers. The dose tiers will be increasing in both intensity and duration of the stimulation. The occurrence of symptomatic intracranial hemorrhage will determine the pace of the escalation through the dose tiers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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 years.
- •New focal neurologic deficit consistent with acute ischemic stroke.
- •Baseline NIHSS ≥ 4 or NIHSS < 4 in the presence of disabling deficits (e.g. aphasia)
- •Presence of acute occlusion of ICA or MCA (including MCA peripheral cortical branches) according to clinical picture and baseline CTA/CTP scan.
- •Presence of salvageable penumbra with Tmax > 6 sec/ ischemic core volume (rCBF < 30%) ≥ 1.2 on baseline CTP scan.
- •Patient is ineligible for EVT per current national guidelines (Cerebrovascular Section of Czech Neurological Society ČLS JEP).
- •Subject is able to be treated with tDCS within 24 hours of last known well time.
- •A signed informed consent is obtained from the patient or patient's legally authorized representative (point 30 of Declaration of Helsinki).
排除标准
- •Acute intracranial hemorrhage including suspected subarachnoid hemorrhage.
- •Other than ischemic cause of acute neurological deficit (stroke mimics:postparoxysmal Todd´s palsy, metabolic cause, tumor, meningoencephalitis etc.).
- •Evidence of a large Ischemic core volume on baseline CTP: volume of rCBF<30% ≥ 100ml.
- •Subacute or chronic subdural hematoma or hygroma.
- •Intra-axial malignant brain tumor.
- •History of spontaneous ICH in the past.
- •History of seizure disorder or new seizures with presentation of current stroke.
- •History of intracranial surgery.
- •Presence of tDCS contraindications: skin lesion at the site of stimulation (open wound, acute inflammation of skin or subcutaneous tissue, burns etc.); skull defect at the site of stimulation (e.g. skull fracture, postcraniectomy); implanted electric device (pacemaker, ICD, DBS, cochlear implant etc.); presence of metal material in head (e.g. metal stent, clamps etc.).
- •Thrombocytopenia < 100 000/ul.
- •INR > 3,
- •Heparin or LMWH therapy in last 48 hours with aPTT increased more than 1,5 times over limit of the laboratory.
- •History of acute overdose by DOAC.
- •Known congenital or acquired increased bleeding propensity.
- •Suspected or confirmed pregnancy.
- •Known CT iodine contrast allergy.
- •Known renal dysfunction (eGFR<30 ml/min.).
- •Signs or symptoms of acute myocardial infarction, including ECG findings, on admission.
- •Suspicion of aortic dissection on admission.
- •Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol including attendance at the 3-month follow-up visit.
- •Concomitant experimental therapy.
研究组 & 干预措施
Transcranial Direct Current Stimulation
干预措施: Soterix Medical 1X1 tDCS stimulator (active C-tDCS) (Device)
Sham Stimulation
干预措施: Soterix Medical 1X1 tDCS stimulator (sham stimulation) (Device)
结局指标
主要结局
Primary safety outcome: the rate of symptomatic intracranial hemorrhage (SICH) in the active treatment arm compared to sham arm, and between higher and lower dose tiers.
时间窗: At 24-hour post-stimulation
The presence of SICH will be assessed on 24-hour post-stimulation non-contrast CT scan. SICH will be defined as an intracranial hemorrhage with an increase of ≥ 4 points on the National Institute of Health Stroke Scale (NIHSS) within 24h after stimulation. In case of sudden worsening of neurostatus anytime within first 24 hours after stimulation, first follow-up CT will be performed immediately (earlier). The treatment will be considered to have exhibited adequate safety if tDCS results in lower or equivalent rates of SICH compared to sham.
次要结局
- Secondary safety outcome: the rate of early neurologic deterioration in the active treatment arm compared to sham arm, and between higher and lower dose tiers.(During the 24-hour post-stimulation)
- Secondary safety outcome: the rate of mortality in the active treatment arm compare to sham arm, and between higher and lower dose tiers.(By day 90 post stimulation)
- Secondary safety outcome: the rate of asymptomatic intracranial hemorrhage (AICH) in the active treatment arm compared to sham arm, and between higher and lower dose tiers.(At 24-hour post-stimulation)
- Secondary safety outcome: the rate of all serious adverse events occurring during the 90 days of study participation in the active treatment arm compare to sham arm, and between higher and lower dose tiers.(By day 90 post-stimulation)
研究者
Matej Slovak
MD
General University Hospital, Prague