To demonstrate safety of low frequency transcranial ultrasound (300 KHz, NeuroFlow) in combination with intravenous rt-PA in acute ischemic stroke patients.
- Tissue plasminogen activator (Activase®)Drug
Other Names: Alteplase; tPA Intervention Desc: Thrombolytic
Controlled pilot study with alternating patient allocation.
Patients are screened using MRI, MR angiography, DWI, PWI and TCD. NeuroFlow ultrasound is administered for 75 minutes during and after t-PA infusion. Patients assessed using MRI, MR angiography, DWI, PWI and TCD at 3 and 24 hours post-treatment and CT at 24 hours. Clinical follow-up at 24 and 72 hours and 7, 30 and 90 days.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Incidence of intracerebral hemorrhage (ICH) with clinical worsening (>4 NIHSS points) within 24 hours of rt-PA infusion, death within 3 months after treatment.|
|Secondary||Secondary endpoints include: recanalization on TCD, NIHSS (neurologic deficit), Barthel Index (disability), modified Rankin Scale (dependence), Stroke Impact Scale (quality of life), secondary intracerebral hemorrhage, mortality.|