Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)

PhotoThera

Status and phase: Completed; Phase 3

Conditions: Ischemic Stroke

Treatments: Device: NeuroThera® Laser System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00419705

NTS-INT06-007

Details and patient eligibility

About

The purpose of this pivotal study is to demonstrate safety and effectiveness of the NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for each Subject within 24 hours of stroke onset.

Full description

This study is a prospective, double blind, randomized, sham controlled, parallel group, multi-center study that will include enrollment of up to 660 Subjects. Subjects will be followed for 90 days post stroke onset. The primary effectiveness endpoint for this study will be the binary endpoint that defines success as a modified Rankin Scale (mRS) score of 0-2 and failure as an mRS score of 3-6 at 90 days or the last rating. The secondary effectiveness endpoint for this study will be the change in NIHSS score from baseline to 90 days or the last rating, analyzed across the full range of scores on the NIHSS. Tertiary effectiveness endpoints include: The 90-day binary endpoint, denoted as the 90-day bNIH score, based on the NIHSS score that defines a successful result as either (i) an improvement of 9 or more points on the NIHSS or (ii) a final NIHSS score of 0 or 1; the score on the mRS at 90 days or the last rating analyzed across the range of scores from 0 to 6 on the mRS scale, SIS-16 at 90 days; mortality at 30, 60 and 90 days.

Enrollment: 660 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of Acute Ischemic Stroke within 24 hours
2. Clinical diagnosis of Acute Ischemic Stroke after exclusion of hemorrhage by a CT scan or susceptibility weighted MRI sequences
3. NIHSS ≥7 - ≤22

Exclusion criteria

1. >24hours from symptom onset to time of treatment
2. Evidence of intracranial, subdural, or subarachnoid hemorrhage
3. Clinical presentation of intracranial hemorrhage
4. Pre stroke ≥3 mRS
5. The presence of a brainstem or cerebellar stroke
6. Transient Ischemic Attack (TIA)
7. Seizure at stroke onset
8. Blood glucose >400 or <60
9. Sustained systolic BP >220mmHG < 80mmHG or diastolic >140mmHG <50mmHG
10. Septic embolus
11. CNS tumor (except asymptomatic meningioma)
12. Dermatologic condition of the scalp (e.g. Psoriasis)
13. Thrombolytic therapy
14. Head implant (e.g. Clipped aneurysm, Hakim valve)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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660 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