Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety Outcome: Rate of Symptomatic Intracranial Hemorrhage (SICH) in the Active Treatment Arms Compared to Sham Arm
研究概览
简要总结
This proposal is a prospective, single-center, dose-escalation safety, tolerability, feasibility and potential efficacy study of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion who are ineligible for intravenous thrombolysis and endovascular therapy.
详细描述
This is a single center, sham-controlled, dose escalation study where cathodal tDCS is delivered to threatened but not yet irreversibly damaged (penumbral) tissue in patients with large vessel occlusion who are not eligible for blood flow restoring recanalization procedures. Patients will be randomized in a 3:1 design, to cathodal versus sham (control) stimulation, 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
- •New focal neurologic deficit consistent with AIS
- •NIHSS≥4 or NIHSS <4 in the presence of disabling deficits
- •Presence of any cortical vessel occlusion including ICA, branches of MCA, Anterior Cerebral artery (ACA), Posterior Cerebral artery (PCA), Posterior-Inferior cerebellar artery (PICA);
- •Presence of salvageable penumbra with Tmax> 6 sec/ ischemic core volume (ADC < 620 μm2/s or rCBF< 30%) ≥ 1.2
- •Patient ineligible for IV tPA, per national AHA/ASA Guidelines
- •Patient ineligible for endovascular therapy per AHA/ASA national Guidelines - one or more of: poor prestroke functional status (mRS score >1), mild neurological symptoms (NIHSS <6), large ischemic core (ASPECTS <6), thrombectomy not technically performable due to severe vessel tortuosity, cervical artery chronic occlusion, or other unfavorable angioarchitectural features that preclude endovascular access to the target intracranial vessel. 8) 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
排除标准
- •Acute intracranial hemorrhage
- •Evidence of a large Ischemic core volume (ADC < 620 μm2/s or rCBF< 30%) ≥ 100
- •Presence of tDCS contraindications - electrically or magnetically activated intracranial metal and non-metal implants.
- •Severe MR contrast allergy or renal dysfunction with eGFR<30ml/min, precluding MRI gadolinium or CT iodine contrast
- •Signs or symptoms of acute myocardial infarction, including EKG findings, on admission
- •Suspicion of aortic dissection on admission
- •History of seizure disorder or new seizures with presentation of current stroke
- •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
- •Preexisting scalp lesion at the site of the stimulation or presence of skull defects (may alter current flow pattern)
- •Preexisting coagulopathy, consist of platelet count of ≤ 100, INR ≥ 3, PTT ≥ 90.
研究组 & 干预措施
Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation
干预措施: Transcranial Direct Current Stimulation (Device)
Sham Stimulation
Sham Stimulation
干预措施: Sham Stimulation (Other)
结局指标
主要结局
Safety Outcome: Rate of Symptomatic Intracranial Hemorrhage (SICH) in the Active Treatment Arms Compared to Sham Arm
时间窗: At 24-hour post-stimulation
The presence of SICH will be assessed on 24-hour post-stimulation scan. SICH will be defined as an intracranial parenchymal hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage with an increase of 4 or more points on the National Institute of Health Stroke Scale (NIHSS) within 24 hours of stimulation.The treatment will be considered to have exhibited adequate safety if tDCS results in lower or equivalent rates of SICH compared to sham. The NIHSS is a validated quantitative assessment tool to measure stroke-related neurological deficits and ranges from 0 (no neurological deficits) to a maximum of 42, indicative of a very severe level of impairment.
Feasibility Outcome: Speed With Which HD C-tDCS Was Implemented
时间窗: Time from randomization to tDCS initiation assessed up to 30 minutes
The median time from enrollment to HD C-tDCS initiation in the last 4 enrolled patients included three Active-Tier 2 patients and one sham.
Tolerability Outcome: Percentage of the Patients Completing the Protocol-assigned Stimulation Treatment
时间窗: After 20 minutes of stimulation period
Percentage of the patients completing the protocol-assigned stimulation treatment
次要结局
- Secondary Safety Outcome: Rate of Early Neurologic Deterioration in All Active Patients Compared to Sham Arm(During the 24-hour post-stimulation)
- Secondary Safety Outcome: Rate of Mortality in All Active Patients Compared to Sham Arm,(By day 90 post stimulation)
- Secondary Safety Outcome: Rate of All Serious Adverse Events Occured During the 90 Days of Study Participation in All Active Patients Compared to Sham.(By day 90 post-stimulation)
研究者
Mersedeh Bahr Hosseini, MD
Principal Investigator
University of California, Los Angeles