None listed
Conditions
Interventions
Group 1 Type of group
Patients receive transcranial laser therapy
Group name:Group 2 Type of group
Patients receive simulated transcranial laser therapy (placebo)
Sponsors
PHOTOTHERA INC.,
Eligibility
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Clinical diagnosis of acute ischemic stroke • Subject is not a candidate for treatment with neurothrombectomy • Initiation of the TLT procedure begins between 4.5 and 24 hours • Baseline NIHSS score range: 7-17 • Full functional independence just prior to the present stroke episode • Negative pregnancy test in females of childbearing potential • Subject Informed Consent obtained prior to enrollment into this study
Exclusion criteria
Exclusion criteria: • Evidence of an intracranial, subdural, or subarachnoid hemorrhage • Acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small deep infarctions, or massive hemispheric strokes • Seizure at stroke onset or within the 7 days prior to stroke onset • Sustained blood glucose >300 or 220 mmHg or DBP >140 mmHg) • Sustained hypotension (SBP <80 mmHg or DBP <50 mmHg) • A presumed and/or confirmed septic embolus • History of CNS vascular disease (e.g. aneurysm, AVM) or history of CNS disease or damage (e.g. neoplasm or dementia) which may influence the subject´s outcome assessment. • Head implant of any kind • Significant skin condition of the scalp (eg. psoriasis) • Use of any intravenous or intra-arterial thrombolytic medication • Use of any diagnostic or therapeutic interventional neurovascular procedure • Female who is pregnant or lactating or who is of childbearing potential and not using a medically acceptable method of birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Specifically, the analysis will be performed using a hierarchical model that incorporates previous data from the NEST-2 study designed to prevent exacerbation of type I error, in accordance with the FDA Guide for the use of Bayesian statistics in clinical trials with medical devices ( February 5, 2006). Measure:Dichotomized result of the 90-day mRS score Timepoints:90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:For the result in which the mRS ordinal scale is used, the null hypothesis is that there is no difference between the SCG and TLTG groups with respect to the underlying distribution of the mRS scores as stated in the contingency tables of 2 by 6 stratified according to baseline NIHSS score, TESO and age. Measure:Distribution of mRS scores at day 90 (Change in Rankin test) Timepoints:90 days | — |
Countries
Austria, Canada, Finland, France, Germany, Peru, Spain, Sweden, Switzerland, United States
Contacts
Public ContactYngrid Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed