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

PhotoThera

Status and phase: Completed; Phase 3

Conditions: Acute Ischemic Stroke

Treatments: Device: NeuroThera® Laser System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01120301

NTS-INT08-009

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,000 participants in 2 patient groups

Transcranial Laser Therapy

Experimental group

Treatment:

Device: NeuroThera® Laser System

Sham control procedure

Sham Comparator group

Treatment:

Device: NeuroThera® Laser System