--- title: Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2) nct_id: NCT00419705 overall_status: COMPLETED phase: PHASE3 sponsor: PhotoThera, Inc study_type: INTERVENTIONAL primary_condition: Ischemic Stroke countries: United States, Germany, Peru, Sweden canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00419705.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00419705" ct_last_update_post_date: 2011-06-09 last_seen_at: "2026-05-12T06:21:45.151Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2) **Official Title:** 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 **NCT ID:** [NCT00419705](https://clinicaltrials.gov/study/NCT00419705) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 660 - **Lead Sponsor:** PhotoThera, Inc - **Conditions:** Ischemic Stroke - **Start Date:** 2006-12 - **Completion Date:** 2008-07 - **CT.gov Last Update:** 2011-06-09 ## 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. ## Eligibility - **Minimum age:** 40 Years - **Maximum age:** 90 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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) ``` ## Arms - **Transcranial Laser Therapy** (EXPERIMENTAL) - **Sham control procedure** (SHAM_COMPARATOR) ## Interventions - **NeuroThera® Laser System** (DEVICE) — Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp ## Primary Outcomes - **Disability scale (mRS)score at 90 days; safety of the treatment procedure** _(time frame: at baseline, day 5, 30, 60 and 90 post treatment)_ ## Secondary Outcomes - **Functional neurological scale(NIHSS)over time** _(time frame: at baseline, Day 5, 30, 60 and 90)_ ## Locations (58) - Sparks Regional Medical Center, Fort Smith, Arkansas, United States - Alta Bates Summit Medical Center, Berkeley, California, United States - Scripps Encinitas Hospital, Encinitas, California, United States - Grossmont Hospital, La Mesa, California, United States - UCLA Medical Center, Los Angeles, California, United States - Tri City Medical Center, Oceanside, California, United States - Stanford Hospital and Clinics, Palo Alto, California, United States - Sharp Healthcare, San Diego, California, United States - Neurology Medical Group of Diablo Valley, Walnut Creek, California, United States - Swedish Medical Center, Englewood, Colorado, United States - The Stroke Center at Hartford Hospital, Hartford, Connecticut, United States - North Broward Medical Center, Deerfield Beach, Florida, United States - Holy Cross Hospital, Fort Lauderdale, Florida, United States - Health First Holmes Regional Medical Center, Melbourne, Florida, United States - Naples Community Hospital, Naples, Florida, United States - Munroe Regional Medical Center, Ocala, Florida, United States - Fawcett Memorial Hospital, Port Charlotte, Florida, United States - Dekalb Medical Center, Decatur, Georgia, United States - Dekalb Neurology Associates LLC, Decatur, Georgia, United States - The Queen's Medical Center, Honolulu, Hawaii, United States - Intensive Care Unit, Northwestern Memorial Hospital, Chicago, Illinois, United States - Loyola University Chicago, Maywood, Illinois, United States - Parkview Hospital, Fort Wayne, Indiana, United States - University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States - Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States - University Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States - North Memorial Medical Center, Robbinsdale, Minnesota, United States - St. Luke's Hospital, Kansas City, Missouri, United States - Saint Louis University, St Louis, Missouri, United States - Benefis Healthcare East Campus, Great Falls, Montana, United States - Virtua Memorial Hospital of Burlington County, Mount Holly, New Jersey, United States - The Valley Hospital, Ridgewood, New Jersey, United States - Mission Hospitals - Memorial Campus, Asheville, North Carolina, United States - UNC Health Care, Chapel Hill, North Carolina, United States - Duke University Medical Center, Durham, North Carolina, United States - The Moses H. Cone Memorial Hospital, Greensboro, North Carolina, United States - Forsyth Medical Center, Winston-Salem, North Carolina, United States - The University Hospital, Cincinnati, Ohio, United States - The Cleveland Clinic Foundation, Cleveland, Ohio, United States - Providence Portland Hospital, Portland, Oregon, United States - Oregon Health & Science University - Oregon Stroke Center, Portland, Oregon, United States - Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States - Hospital of University of Pennsylvania, Philadelphia, Pennsylvania, United States - Roper Hospital, Charleston, South Carolina, United States - Erlanger Health System, Chattanooga, Tennessee, United States - The Methodist Hospital, Houston, Texas, United States - Virginia Commonwealth University Medical Center, Richmond, Virginia, United States - Sentara Virginia Beach General Hospital, Virginia Beach, Virginia, United States - Winchester Medical Center, Winchester, Virginia, United States - Charleston Area Medical Center (CAMC) General Hospital, Charleston, West Virginia, United States - University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States - Neurologische Klinik des Universitatsklinikum Erlangen, Erlangen, Germany - Neurologische Klinik des Universitatsklinikum Heidelberg, Heidelberg, Germany - Klinik und Poliklinik fur Neurologic Leipzig, Leipzig, Germany - Neurologische Klinik und Poliklinik Westfalische Wilhelms Universitat, Münster, Germany - Hospital Nacional "Dos de Mayo", Lima, Peru - Sahlgrenska University Hospital, Gothenburg, Sweden - Sjukhuset i Lidkoping, Lidköping, Sweden ## Recent Field Changes (last 30 days) - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.sparks regional medical center|fort smith|arkansas|united states` — added _(2026-05-12)_ - `locations.alta bates summit medical center|berkeley|california|united states` — added _(2026-05-12)_ - `locations.scripps encinitas hospital|encinitas|california|united states` — added _(2026-05-12)_ - `locations.grossmont hospital|la mesa|california|united states` — added _(2026-05-12)_ - `locations.ucla medical center|los angeles|california|united states` — added _(2026-05-12)_ - `locations.tri city medical center|oceanside|california|united states` — added _(2026-05-12)_ - `locations.stanford hospital and clinics|palo alto|california|united states` — added _(2026-05-12)_ - `locations.sharp healthcare|san diego|california|united states` — added _(2026-05-12)_ - `locations.sjukhuset i lidkoping|lidköping||sweden` — added _(2026-05-12)_ - `locations.neurology medical group of diablo valley|walnut creek|california|united states` — added _(2026-05-12)_ - `locations.swedish medical center|englewood|colorado|united states` — added _(2026-05-12)_ - `locations.the stroke center at hartford hospital|hartford|connecticut|united states` — added _(2026-05-12)_ - `locations.north broward medical center|deerfield beach|florida|united states` — added _(2026-05-12)_ - `locations.holy cross hospital|fort lauderdale|florida|united states` — added _(2026-05-12)_ - `locations.health first holmes regional medical center|melbourne|florida|united states` — added _(2026-05-12)_ - `locations.naples community hospital|naples|florida|united states` — added _(2026-05-12)_ - `locations.munroe regional medical center|ocala|florida|united states` — added _(2026-05-12)_ - `locations.fawcett memorial hospital|port charlotte|florida|united states` — added _(2026-05-12)_ - `locations.dekalb medical center|decatur|georgia|united states` — added _(2026-05-12)_ - `locations.dekalb neurology associates llc|decatur|georgia|united states` — added _(2026-05-12)_ - `locations.the queen's medical center|honolulu|hawaii|united states` — added _(2026-05-12)_ - `locations.intensive care unit, northwestern memorial hospital|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.loyola university chicago|maywood|illinois|united states` — added _(2026-05-12)_ - `locations.parkview hospital|fort wayne|indiana|united states` — added _(2026-05-12)_ - `locations.university of kentucky chandler medical center|lexington|kentucky|united states` — added _(2026-05-12)_ - `locations.beth israel deaconess medical center|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.university massachusetts memorial medical center|worcester|massachusetts|united states` — added _(2026-05-12)_ - `locations.north memorial medical center|robbinsdale|minnesota|united states` — added _(2026-05-12)_ - `locations.st. luke's hospital|kansas city|missouri|united states` — added _(2026-05-12)_ - `locations.saint louis university|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.benefis healthcare east campus|great falls|montana|united states` — added _(2026-05-12)_ - `locations.virtua memorial hospital of burlington county|mount holly|new jersey|united states` — added _(2026-05-12)_ - `locations.the valley hospital|ridgewood|new jersey|united states` — added _(2026-05-12)_ - `locations.mission hospitals - memorial campus|asheville|north carolina|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00419705.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00419705* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*