Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3) "NEST-3"

Completed

Phase 3 Results N/A

Trial Description

The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.

Conditions

Interventions

  • NeuroThera┬« Laser System Device
    Intervention Desc: Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
    ARM 1: Kind: Experimental
    Label: Transcranial Laser Therapy
    ARM 2: Kind: Experimental
    Label: Sham control procedure

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Disability assessed using the dichotomous modified Rankin Scale (mRS) Day 90 No
Primary Adverse event differences between transcranial laser therapy and sham Day 90 Yes
Secondary Distribution of scores across the ordinal mRS Day 90 No
Secondary Binary outcome measure of the National Institute of Health Stroke Scale (bNIH) Day 90 No

Sponsors