Transcranial Laser Therapy and Infarct Volume

Abstract

Background and Purpose— Two randomized trials suggested that transcranial laser therapy (TLT) may benefit patients with acute ischemic stroke, although efficacy has not been confirmed. Supportive proof of concept could be demonstrated if TLT reduces the volume of cortical infarction. Methods— The NeuroThera Efficacy and Safety Trial-2 (NEST-2) was a randomized trial of TLT versus sham in patients with acute ischemic stroke treated within 24 hours of onset. Infarct volumes were measured quantitatively and semiquantitatively on all protocol-required computed tomography (or MRI, if clinically indicated) scans performed on day 5 (±2). Two approaches assessed treatment effects on cortex: (1) indirectly, by analyzing total infarct volume among patients with clinical presentations suggesting cortical involvement; and (2) directly, by assessing the cortical Alberta Stroke Program Early CT Score (cASPECTS) components (M1-M6, anterior, posterior) on a 0- to 8-point modified scale. Results— A total of 640 subjects had scans (576 computed tomography, 64 MRI) on day 5. The reliability of ASPECTS (intraclass correlation coefficient=0.85) and cASPECTS (intraclass correlation coefficient=0.82) was excellent, and total ASPECTS was correlated with total infarct volume ( r =0.71). In the overall study population, there was no impact of TLT on total infarct volume ( P =0.30), total ASPECTS ( P =0.85), or cASPECTS ( P =0.89). Similarly, no effect was seen in any of the following prespecified subgroups selected to indicate cortical involvement: baseline National Institutes of Health Stroke Scale score >10, Oxfordshire Total Anterior Circulation Syndrome, subjects with aphasia or extinction at baseline, or subjects with radiographic involvement of cortex. Conclusions— TLT was not associated with a reduction in overall or cortical infarct volume as measured on computed tomography in the subacute phase.

Laser Therapy and Stroke: Quantification of Methodological Requirements in Consideration of Yellow Laser

“…Scientists try to demonstrate a possible therapeutic success with the collection of complex clinical scores and by using highly complicated measuring methods (e.g., nearinfrared spectroscopy) [4,5]. The studies with laser and partly "light-emitting diodes" (LED) [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21] are currently being conducted worldwide with different success.…”

Transcranial Near-Infrared Laser Transmission (NILT) Profiles (800 nm): Systematic Comparison in Four Common Research Species

“…Based upon efficacy in 2 species, 3 NeuroThera Effectiveness and Safety Trial (NEST) clinical trials [ 15 – 17 ] were mounted consecutively to evaluate the efficacy of CW TLT [ 15 – 17 , 26 ] in stroke patients. In the 3 randomized and blinded trials, NEST-1 [ 15 ], NEST-2 [ 16 , 17 ] and NEST-3 [ 18 ], continuous wave CW TLT was used within approximately 24 hours of an ischemic stroke, although this was variable amongst the 3 trials.…”

Fast Neuroprotection (Fast-NPRX) for Acute Ischemic Stroke Victims: the Time for Treatment Is Now

“…: SAINT, DIAS, NEST) and their cosmic repercussions. For example, the development of novel drugs approaches(19–22), thrombolytics(23–26) and devices(27–29) has slowed or halted due to late stage clinical trial futility even with some efficacy in early rounds of clinical trials. With the exception of tissue plasminogen activator (rt-PA)(30) and tenecteplase(31, 32) [but also see(33)], which has a higher fibrin binding specificity that rt-PA and possibly greater resistance to inactivation by plasminogen activator inhibitor-1 (PAI-1; serpin-1), an endogenous inhibitor of plasminogen activator compared to rt-PA, there continues to be lack of significant efficacy of all forms of treatment in a diverse and heterogeneous patient population.…”

“…Within the current DTN for rt-PA, it can be estimated that a stroke patient loses 120 × 10 6 neurons if treated with 60 minutes. To put this neuronal loss into perspective, the recent SAINT trial used a mean time to treatment of 3.76 hours(19, 20) (7.52 million neurons) and the NEST trial (16 hours or 32 million neurons)(27–29, 83). Clearly, we should strive to provide patients with a neuroprotective therapy that can be administered a soon as possible after confirmation of a stroke, and if possible, it should not be dependent upon the type of stroke with which the patient presents.…”