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

Trial ID or NCT#

NCT01120301

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

NeuroThera® Efficacy and Safety Trial - 3 (NEST-3) A Double-blind, Randomized, Sham-controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Efficacy of Transcranial Laser Therapy With the NeuroThera® Laser System for the Treatment of Acute Ischemic Stroke Within 24 Hours of Stroke Onset

Eligibility Criteria

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Clinical diagnosis of acute ischemic stroke 2. Subject is not a candidate for treatment with neurothrombectomy 3. Initiation of the TLT procedure begins between 4.5 and 24 hours 4. Baseline NIHSS score range: 7-17 5. Full functional independence just prior to the present stroke episode 6. Negative pregnancy test in females of childbearing potential 7. Subject Informed Consent obtained prior to enrollment into this study
Exclusion Criteria:
  1. 1. Evidence of an intracranial, subdural, or subarachnoid hemorrhage 2. Acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small deep infarctions, or massive hemispheric strokes 3. Seizure at stroke onset or within the 7 days prior to stroke onset 4. Sustained blood glucose >300 or <60 mg/dl 5. Sustained hypertension (SBP >220 mmHg or DBP >140 mmHg) 6. Sustained hypotension (SBP <80 mmHg or DBP <50 mmHg) 7. A presumed and/or confirmed septic embolus 8. 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. 9. Head implant of any kind 10. Significant skin condition of the scalp (eg. psoriasis) 11. Use of any intravenous or intra-arterial thrombolytic medication 12. Use of any diagnostic or therapeutic interventional neurovascular procedure 13. Female who is pregnant or lactating or who is of childbearing potential and not using a medically acceptable method of birth control.
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Investigator(s)

Anna Finley Caulfield, MD
Anna Finley Caulfield, MD
Neurocritical care specialist
Clinical Professor, Neurology & Neurological Sciences
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Stroke and vascular neurologist, Neurocritical care specialist
Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery
Maarten Lansberg, MD, PhD
Maarten Lansberg, MD, PhD
Stroke and vascular neurologist, General neurologist
Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery

Contact us to find out if this trial is right for you.

Contact

Stephanie Kemp
6507234481

View on ClinicalTrials.gov