Safety of tPA + Transcranial Emission of Low-Energy Lasers for Acute Stroke Recovery - Results (P4.219)

Objective: To assess the safety and preliminary efficacy of combining intravenous tPA with transcranial laser therapy (TLT) in subjects treated for acute ischemic stroke. Background: Neuroprotection with TLT had shown promise in preliminary clinical trials without thrombolysis. The Safety of tPA + Transcranial Emission of Low-Energy Lasers for Acute Stroke Recovery (StELLAR) study aimed to assess the safety and preliminary efficacy of combining intravenous tPA with TLT using the NeuroThera® Laser System in subjects treated for acute ischemic stroke. We present the only data on the combined use of TLT and thrombolysis in humans. Methods: StELLAR was a double-blind, randomized, sham-controlled, multi-center, safety and preliminary efficacy study of IV tPA, within 3 hours, versus IV tPA plus transcranial laser therapy (TLT). Patients (age 40-80, baseline NIHSS 7-17) were randomized (1:1) to receive sham TLT procedure or active TLT. Primary endpoints for the study were rate of symptomatic intracranial hemorrhages at 36 hours (safety) and mRS 0-1 at 90 days (efficacy). We compared frequency of serious adverse events (SAE) especially recurrent stroke between groups. We aimed to enroll 200 patients, however, the study was prematurely stopped after the maker of the TLT system, PhotoThera™ declared bankruptcy. Results: Of 12 subjects, 7 received tPA only, 5 tPA+TLT. Baseline demographics, including NIHSS (12.3±3.2 v 15.0±2.4) were well balanced. No patient experienced sICH, the frequency patients experiencing at least one SAE (3 versus 2) were not significantly different between groups. We found no recurrent stroke within 90 days, one patient in the TLT group died (NS). Good 90-day (mRS 0-1) outcome was found in 3 versus 2 patients (42.9 v 40%, NS). Conclusion: Transcranial Laser in this small exploratory study was well tolerated in combination with IV tPA. Larger studies are needed to explore if the combination of LASER therapy plus tPA is safe and shows better outcome than IV tPA alone. Study supported by NIH Grant P50 NS044148 Clinical Trial Registry: NCT01220739