Transcranial Low-Frequency Ultrasound Mediated Thrombolysis in Brain Ischemia Study "TRUMBI"

Completed

Phase N/A Results

Trial Description

To demonstrate safety of low frequency transcranial ultrasound (300 KHz, NeuroFlow) in combination with intravenous rt-PA in acute ischemic stroke patients.

Interventions

Trial Design

Controlled pilot study with alternating patient allocation.

Patient Involvement

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.

Outcomes

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.

Sponsors

Walnut Technologies, Boston