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

NeuroThera® Effectiveness and Safety Trial - 2 (NEST-2) A Double Blind, Randomized, Controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Effectiveness of the Treatment of Acute Ischemic Stroke With the NeuroThera® Laser System Within 24 Hours From Stroke Onset

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00419705

Enrollment

660

Registered

2007-01-09

Start date

2006-12-31

Completion date

2008-07-31

Last updated

2011-06-09

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

Conditions

Ischemic Stroke

Keywords

acute stroke, infrared laser therapy, clinical trial, safety, effectiveness

Brief summary

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.

Detailed 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.

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 90 Years

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)

Design outcomes

Primary

Measure	Time frame
Disability scale (mRS)score at 90 days; safety of the treatment procedure	at baseline, day 5, 30, 60 and 90 post treatment

Secondary

Measure	Time frame
Functional neurological scale(NIHSS)over time	at baseline, Day 5, 30, 60 and 90

Countries

Germany, Peru, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026