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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01120301

Acronym

NEST-3

Enrollment

1000

Registered

2010-05-10

Start date

2010-09-30

Completion date

Unknown

Last updated

2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

stroke

Brief summary

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.

Interventions

DEVICENeuroThera® Laser System

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

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. 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.

Design outcomes

Primary

Measure	Time frame
Disability assessed using the dichotomous modified Rankin Scale (mRS)	Day 90
Adverse event differences between transcranial laser therapy and sham	Day 90

Secondary

Measure	Time frame
Distribution of scores across the ordinal mRS	Day 90
Binary outcome measure of the National Institute of Health Stroke Scale (bNIH)	Day 90

Countries

Austria, Canada, Finland, France, Germany, Peru, Spain, Sweden, Switzerland, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026