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Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
Summary
Acute ischemic stroke may result in substantial disability despite timely reperfusion therapy because ischemic and reperfusion-related brain injury can continue before, during, and after restoration of blood flow. This investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint trial will evaluate whether a protocolized Stimulation-Temperature-Oxygen-Positioning (STOP) multimodal neuroprotective strategy added to guideline-based reperfusion therapy and stroke-unit care improves 90-day functional outcome compared with standard care alone. A total of 380 adults with acute ischemic stroke treated with intravenous thrombolysis and/or endovascular therapy within 24 hours of symptom onset or last known well will be randomized in a 1:1 ratio to the STOP strategy plus standard care or standard care alone. The STOP strategy comprises transcutaneous auricular vagus nerve stimulation, protocolized normothermia targeting a body temperature of 37.5 °C or lower, high-flow normobaric oxygen, and dynamic head positioning according to reperfusion treatment and recanalization status. The primary outcome is the ordinal distribution of modified Rankin Scale scores at 90 days after randomization. Blinded assessors will evaluate functional outcomes, and a blinded central imaging core laboratory will adjudicate imaging outcomes. Among participants with anterior-circulation large-vessel occlusion who undergo endovascular treatment and achieve successful reperfusion (final mTICI grade 2b-3), eligible and consenting participants may enter an embedded randomized substudy comparing selective intra-arterial hypothermia with no additional intra-arterial infusion. The second randomization will occur only after successful reperfusion has been confirmed.
Official title: Stimulation-Temperature-Oxygen-Positioning (STOP) Multimodal Neuroprotective Strategy for Acute Ischemic Stroke Undergoing Reperfusion Therapy: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
380
Start Date
2026-11-01
Completion Date
2028-12-31
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Stimulation-Temperature-Oxygen-Positioning (STOP) Multimodal Neuroprotective Strategy
The STOP strategy comprises four protocolized nonpharmacological interventions added to guideline-based care: (1) taVNS to the left auricular vagus nerve region (0.5 mA, 25 Hz, 200 μs, 20 min every 12 h for 5 days; first session as early as feasible and within 24 h after final reperfusion treatment); (2) temperature management targeting body temperature ≤37.5 °C through 72 h after final reperfusion treatment; (3) high-flow normobaric oxygen initiated as early as possible, preferably before or at reperfusion treatment, at 10 L/min by reservoir mask in non-intubated patients or FiO2 1.0 in intubated patients, for 4 h; and (4) dynamic head positioning: IVT-only patients will remain supine (0°) for 24 h. EVT patients will remain supine (0°) before thrombectomy when feasible. After EVT, patients with mTICI ≥2b will receive 30° head elevation, while those with mTICI \<2b will receive -20° Trendelenburg positioning for 24 h, when clinically safe and tolerated.
Guideline-Based Reperfusion Therapy and Standard Stroke-Unit Care
Participants receive guideline-based reperfusion therapy, including intravenous thrombolysis and/or endovascular therapy when clinically indicated, together with standard stroke-unit care according to contemporary national and institutional guidelines. Standard care may include physiological monitoring and management, antithrombotic and lipid-lowering therapy, management of cerebral edema, dysphagia and aspiration precautions, venous thromboembolism prevention, rehabilitation, clinically indicated oxygen therapy, antipyretic treatment, positioning adjustments, and other rescue treatments. Clinically necessary treatment will not be withheld because of trial participation.