Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-27 @ 4:47 AM
Study NCT ID:
NCT03281759
Status:
UNKNOWN
Last Update Posted:
2017-09-13
First Post:
2017-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial LED Therapy for Severe Acute Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070625', 'term': 'Brain Injuries, Diffuse'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D020833', 'term': 'Diffuse Axonal Injury'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-11', 'studyFirstSubmitDate': '2017-09-04', 'studyFirstSubmitQcDate': '2017-09-11', 'lastUpdatePostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE).', 'timeFrame': 'Before stimulation and 1, 3 and 6 months after first stimulation', 'description': 'Evaluation of improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE) after stimulation in comparison to the placebo group.'}], 'secondaryOutcomes': [{'measure': 'Improvement effects of transcranial LED in followup images measured by Marshall computed tomography scale and Adams grading scale for diffuse axonal injury.', 'timeFrame': 'Before stimulation and 1, 3 and 6 months after first stimulation', 'description': 'Evaluation of early and delayed effects of Transcranial LED Therapy (TCLT) to improve followup computed tomography or magnetic resonance of DAI patients after Traumatic Brain Injury, measured by Marshal computed tomography scale, Adams grading scale for diffuse axonal injury and a protocol published by Hamdeh et al. (doi: 10.1089/neu.2016.4426) which graduates the magnitude of diffuse axonal lesion.'}, {'measure': 'Hemodynamic improvement effect of transcranial LED measured by transcranial doppler (systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values).', 'timeFrame': 'Before stimulation and 1, 3 and 6 months after first stimulation', 'description': 'Improvement evaluation of effects of LED therapy in hemodynamic change through transcranial doppler, measuring systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain Injuries, Traumatic;', 'Diffuse Axonal Injury', 'Low-Level Light Therapy', 'Neurologic Manifestations', 'Quality of Life', 'Rehabilitation'], 'conditions': ['Diffuse Axonal Brain Injury', 'Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '29690927', 'type': 'DERIVED', 'citation': 'Santos JGRPD, Zaninotto ALC, Zangaro RA, Carneiro AMC, Neville IS, de Andrade AF, Teixeira MJ, Paiva WS. Effects of transcranial LED therapy on the cognitive rehabilitation for diffuse axonal injury due to severe acute traumatic brain injury: study protocol for a randomized controlled trial. Trials. 2018 Apr 24;19(1):249. doi: 10.1186/s13063-018-2632-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate early and delayed effects of Transcranial LED Therapy (TCLT) and determinate whether this therapy is effective for cognitive rehabilitation of Diffuse Axonal Injury patients after Traumatic Brain Injury.', 'detailedDescription': 'This is a randomized clinical trial of patient with diffuse axonal injury (DAI) secondary to severe Traumatic Brain Injury in its acute stage (less than 8h). It will be recruited thirty adult patients who will receive thirty minutes at three times per week for 6 weeks (18 sessions) of transcranial stimulation. Fifteen of them will be stimulated with LED helmet and the rest with a sham helmet identical to the LED one, but only with a similar red light emission. Patient who meet inclusion criteria will be assessed with Glasgow Outcome Scale Extended (GOS-E) evaluation in at least five different periods (Admission, before and after each stimulation, and at 3 and 6 months later in outpatient followup).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) Patient victims of Traumatic Brain Injury with Glasgow Coma Scale ≤8 on admission:\n\n1. Head CT scan showing diffuse axonal lesion.\n2. CT scan without focal surgical lesions (Marshall I and II) and no signs of intracranial hypertension.\n3. Transcranial Doppler and optic nerve sheath US with no signs of intracranial hypertension.\n4. Admission less than 8 hours of trauma.\n\nExclusion Criteria:\n\n1. History of drug or narcotic abuse.\n2. Emergence of surgical lesions or signs of intracranial hypertension in followup CTs.\n3. Transcranial Doppler or optic nerve sheath US presenting signs of intracranial hypertension.\n4. Psychiatric disorders.\n5. Injury severity score ≥3, according to the Abbreviated Injury Scale'}, 'identificationModule': {'nctId': 'NCT03281759', 'acronym': 'LED-TBI', 'briefTitle': 'Transcranial LED Therapy for Severe Acute Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Effects of Transcranial LED Therapy on the Cognitive Rehabilitation for Diffuse Axonal Injury Due to Severe Acute Traumatic Brain Injury: Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '15425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Coil Helmet', 'description': 'The patients will undergo 18 sessions (627 nm, 70 mW/cm2, 10 J/cm2) at four points of the frontal and parietal region for 30 s each, totaling 120 s three times per week for 6 weeks, lasting 30 minutes of transcranial LED stimulation.', 'interventionNames': ['Device: Transcranial LED Therapy (Active coil helmet)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Inactive Coil Helmet', 'description': 'The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions.', 'interventionNames': ['Device: Transcranial LED Therapy (Inactive coil helmet)']}], 'interventions': [{'name': 'Transcranial LED Therapy (Active coil helmet)', 'type': 'DEVICE', 'description': 'The patients will undergo 18 sessions of repetitive transcranial LED stimulation.', 'armGroupLabels': ['Active Coil Helmet']}, {'name': 'Transcranial LED Therapy (Inactive coil helmet)', 'type': 'DEVICE', 'description': 'The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions, only a similar red light color.', 'armGroupLabels': ['Inactive Coil Helmet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05401-000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Joao G Santos, MD', 'role': 'CONTACT', 'email': 'joao.gustavo.rps@gmail.com', 'phone': '+5511941989876'}], 'facility': 'University of Sao Paulo General Hospital', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Joao G Santos, MD', 'role': 'CONTACT', 'email': 'joao.gustavo.rps@gmail.com', 'phone': '+5511941989876'}, {'name': 'Wellingson S Paiva, PHD', 'role': 'CONTACT', 'phone': '+5511975992245'}], 'overallOfficials': [{'name': 'Wellingson S Paiva, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sao Paulo General Hospital'}, {'name': 'Joao G Santos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}