Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial_ Bridging and Adjunctive Neuroprotection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Primary Safety Outcome- Number of Participants With Symptomatic Intracranial Hemorrhage (SICH)
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 before and after 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 undergoing recanalization procedure. 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. All patients will be receiving the first dose (stimulation cycle) after the recanalization procedure and patients at dose tiers 5-6 will also be receiving stimulation cycles before the recanalization procedure begins.
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
- Single (Participant)
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
- •ICA or M1 or M2 MCA occlusion on pre-thrombectomy MRA or CTA
- •Onset (last-seen-well) time to randomization time within 24 hours
- •Pre-stroke modified Rankin Scale≤
- •Patient ineligible for IV tPA, per national AHA/ASA Guidelines.
- •Having undergone endovascular thrombectomy with less than a complete reperfusion (<TICI 2c, 3) for receiving post-thrombectomy adjunct C-tDCS.
- •Undergoing endovascular thrombectomy, per national AHA/ASA Guidelines for patients who are assigned to pre-thrombectomy bridging session at Tiers 5,
- •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 ml
- •Presence of tDCS contraindications - electrically or magnetically activated intracranial metal and non-metal implants.
- •Pregnancy
- •Severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention.
- •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 a platelet count of ≤ 100, INR ≥ 3, PTT ≥ 90.
研究组 & 干预措施
Stimulation arm
Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. There will be 6 dose tiers:
Tier 1 - 1 mA, and Tier 2- 2 mA: Consist of a single stimulation cycle (20min) after the endovascular procedure (EVT) in patients with TICI<2c,3 and negative immediate post-EVT CT scan for definitive evidence of ICH.
Tier 3 - 1 mA and Tier 4- 2mA consist of 2 treatment cycles after the EVT in patients with TICI<2c and 3, and negative immediate post-EVT CT scan for definitive evidence of ICH.
Tier 5 - 1 mA and tier 6- 2 mA consist of 3 treatment cycles. The first cycle will be up to 20 min cycle, after initial imaging and prior to arterial puncture, the second and third cycles after EVT in patients with TICI<2c and 3 and negative immediate post-EVT CT scan for definitive evidence of ICH.
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
Sham arm
Patients in the sham stimulation arm at all the tiers will have the cap and electrodes in place, and sham switch moved but without delivery of electrical stimulation.
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
Primary Safety Outcome- Number of Participants With Symptomatic Intracranial Hemorrhage (SICH)
时间窗: At 24-hour post-stimulation
Symptomatic intracranial hemorrhage (SICH) is defined as an increase of 4 or more points on the National Institute of Health Stroke Scale (NIHSS) total score within 24 hours of stimulation associated with parenchymal hematoma type 1 (PH1), parenchymal hematoma type 2 (PH2), remote intraparenchymal hemorrhage (RIH), subarachnoid hemorrhage (SAH), or intraventricular hemorrhage (IVH). The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. Accordingly, 0 is the lowest and 42 is the highest total score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
Primary Tolerability Outcome-Number of Participants Completing the Protocol-assigned Stimulation
时间窗: After 5 minutes of stimulation period
The percentage of the patients completing the protocol-assigned stimulation treatment with no intolerability.
Primary Feasibility Outcome- Assessing the Speed of Stimulation Implementation From Randomization.
时间窗: Median time from randomization to tDCS initiation
The median times from randomization to bridging C-tDCS initiation and the time form end of endovascular thrombectomy procedure to adjunctive C-tDCS initiation in the last 10 enrolled patients.
次要结局
- Secondary Safety Outcome-Number of Participants With All Serious Adverse Events (Anticipated and Unanticipated)(At 90 days post-stimulation)
- Secondary Safety Outcome-Number of Participants With Asymptomatic Intracranial Hemorrhage (AICH)(At 24-hour post-stimulation)
- Secondary Safety Outcome-Number of Participants With Early Neurologic Deterioration(At 24-hour post-stimulation)
- Secondary Safety Outcome-Number of Participants With Mortality(At 90 days post-stimulation)
研究者
Mersedeh Bahr Hosseini, MD
Principal Investigator
University of California, Los Angeles