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Therapeutic Areas: Neurology | Hematology | Cardiology/Vascular Diseases | Family Medicine
Disease Category: Stroke
Location: United States, NC

Clinical Trial Details

Overview

Research Study Summary

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

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.

Primary Outcome Measures:

  • Disability assessed using the dichotomous modified Rankin Scale (mRS) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Adverse event differences between transcranial laser therapy and sham [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

  • Distribution of scores across the ordinal mRS [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Binary outcome measure of the National Institute of Health Stroke Scale (bNIH) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Patient 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

Patient 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.

To Learn more
Phase

3

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

Guilford Neurologic Associates
912 Third St. Suite 101
Greensboro, NC 27405
Phone: 336-275-8671

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Research Center Information: Guilford Neurologic Associates

CW ID: 180655

Date Last Changed: July 19, 2013


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