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Completed

NCT Number: NCT01120301

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AKH Linz, Linz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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 <60 mg/dl
  • Sustained hypertension (SBP >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.

Treatment and study plan

NeuroThera® Laser System

Device

Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp

Primary outcomes

  1. Disability assessed using the dichotomous modified Rankin Scale (mRS)

    Time frame: Day 90

  2. Adverse event differences between transcranial laser therapy and sham

    Time frame: Day 90

Secondary outcomes

  1. Distribution of scores across the ordinal mRS

    Time frame: Day 90

  2. Binary outcome measure of the National Institute of Health Stroke Scale (bNIH)

    Time frame: Day 90

Sponsors and collaborators

Lead sponsor

PhotoThera, Inc

Industry

Registry information

Official study 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

Acronym: NEST-3

Important dates

Study start
2010
Primary completion
2012
First posted
May 10, 2010
Registry last updated
Nov 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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