Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00419705
Status:
COMPLETED
Last Update Posted:
2011-06-09
First Post:
2007-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 660}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-07', 'studyFirstSubmitDate': '2007-01-05', 'studyFirstSubmitQcDate': '2007-01-05', 'lastUpdatePostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disability scale (mRS)score at 90 days; safety of the treatment procedure', 'timeFrame': 'at baseline, day 5, 30, 60 and 90 post treatment'}], 'secondaryOutcomes': [{'measure': 'Functional neurological scale(NIHSS)over time', 'timeFrame': 'at baseline, Day 5, 30, 60 and 90'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute stroke', 'infrared laser therapy', 'clinical trial', 'safety', 'effectiveness'], 'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '19233936', 'type': 'RESULT', 'citation': 'Zivin JA, Albers GW, Bornstein N, Chippendale T, Dahlof B, Devlin T, Fisher M, Hacke W, Holt W, Ilic S, Kasner S, Lew R, Nash M, Perez J, Rymer M, Schellinger P, Schneider D, Schwab S, Veltkamp R, Walker M, Streeter J; NeuroThera Effectiveness and Safety Trial-2 Investigators. Effectiveness and safety of transcranial laser therapy for acute ischemic stroke. Stroke. 2009 Apr;40(4):1359-64. doi: 10.1161/STROKEAHA.109.547547. Epub 2009 Feb 20.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of Acute Ischemic Stroke within 24 hours\n2. Clinical diagnosis of Acute Ischemic Stroke after exclusion of hemorrhage by a CT scan or susceptibility weighted MRI sequences\n3. NIHSS ≥7 - ≤22\n\nExclusion Criteria:\n\n1. \\>24hours from symptom onset to time of treatment\n2. Evidence of intracranial, subdural, or subarachnoid hemorrhage\n3. Clinical presentation of intracranial hemorrhage\n4. Pre stroke ≥3 mRS\n5. The presence of a brainstem or cerebellar stroke\n6. Transient Ischemic Attack (TIA)\n7. Seizure at stroke onset\n8. Blood glucose \\>400 or \\<60\n9. Sustained systolic BP \\>220mmHG \\< 80mmHG or diastolic \\>140mmHG \\<50mmHG\n10. Septic embolus\n11. CNS tumor (except asymptomatic meningioma)\n12. Dermatologic condition of the scalp (e.g. Psoriasis)\n13. Thrombolytic therapy\n14. Head implant (e.g. Clipped aneurysm, Hakim valve)'}, 'identificationModule': {'nctId': 'NCT00419705', 'briefTitle': 'Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'PhotoThera, Inc'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NTS-INT06-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial Laser Therapy', 'interventionNames': ['Device: NeuroThera® Laser System']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham control procedure', 'interventionNames': ['Device: NeuroThera® Laser System']}], 'interventions': [{'name': 'NeuroThera® Laser System', 'type': 'DEVICE', 'description': 'Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp', 'armGroupLabels': ['Sham control procedure', 'Transcranial Laser Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72901', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Sparks Regional Medical Center', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Encinitas Hospital', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Grossmont Hospital', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Tri City Medical Center', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Hospital and Clinics', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Healthcare', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Neurology Medical Group of Diablo Valley', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish Medical Center', 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'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Munroe Regional Medical Center', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Fawcett Memorial Hospital', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dekalb Medical Center', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dekalb Neurology Associates LLC', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '92822', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': "The Queen's Medical Center", 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Intensive Care Unit, Northwestern 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