Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-02-10 @ 7:15 PM
Study NCT ID:
NCT01598532
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2012-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of LEDs on Memory in TBI Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001924', 'term': 'Brain Concussion'}], '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': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rzafonte@partners.org', 'phone': '617-952-5227', 'title': 'Ross D. Zafonte, DO', 'organization': 'Spaulding Rehabilitation Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Small sample size \\& Open Protocol'}}, 'adverseEventsModule': {'timeFrame': 'Over a period of 2 years 11 participants were studied with no adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Transcranial LED Treatment', 'description': 'Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light and laser). Each session was 30 minutes in duration.', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stroop Test for Executive Function - Trial 3 - Inhibition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial LED Treatment', 'description': 'MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.'}], 'classes': [{'title': 'Pre-test data', 'categories': [{'measurements': [{'value': '-0.7407', 'spread': '1.1561', 'groupId': 'OG000'}]}]}, {'title': '1 Week post test data', 'categories': [{'measurements': [{'value': '.036', 'spread': '.7407', 'groupId': 'OG000'}]}]}, {'title': '1 Month post test data', 'categories': [{'measurements': [{'value': '.718', 'spread': '1.0133', 'groupId': 'OG000'}]}]}, {'title': '2 Months post test data', 'categories': [{'measurements': [{'value': '.815', 'spread': '.9499', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.004', 'groupIds': ['OG000'], 'groupDescription': 'linear trend over time for the effect of LED treatments', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Univariate, one-way, repeated measure ANOVA with trend analysis', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1-Week, 1-month and 2-months after final LED Treatment', 'description': 'Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.', 'unitOfMeasure': '# of SD units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the Transcranial LED Treatment Group'}, {'type': 'PRIMARY', 'title': 'Stroop Test for Executive Function - Trial 4 Inhibition Switching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial LED Treatment', 'description': 'Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.'}], 'classes': [{'title': 'Pre-test data', 'categories': [{'measurements': [{'value': '-1.050', 'spread': '1.1058', 'groupId': 'OG000'}]}]}, {'title': '1 week post test data', 'categories': [{'measurements': [{'value': '-0.100', 'spread': '1.3994', 'groupId': 'OG000'}]}]}, {'title': '1 Month post test data', 'categories': [{'measurements': [{'value': '.553', 'spread': '1.167', 'groupId': 'OG000'}]}]}, {'title': '2 Month post test data', 'categories': [{'measurements': [{'value': '.854', 'spread': '1.3544', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.003', 'groupIds': ['OG000'], 'groupDescription': 'linear trend over time for the effect of LED treatments', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Univariate, one-way, repeated measure ANOVA with trend analysis', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment', 'description': 'Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.', 'unitOfMeasure': '# of SD Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in Transcranial LED Treatment Group'}, {'type': 'PRIMARY', 'title': 'California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial LED Treatment', 'description': 'Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light and laser). Each session was 30 minutes in duration.'}], 'classes': [{'title': 'Pre-test Data', 'categories': [{'measurements': [{'value': '-.409', 'spread': '.7687', 'groupId': 'OG000'}]}]}, {'title': '1 Week post test data', 'categories': [{'measurements': [{'value': '.364', 'spread': '.809', 'groupId': 'OG000'}]}]}, {'title': '1 Month post test data', 'categories': [{'measurements': [{'value': '.630', 'spread': '.7015', 'groupId': 'OG000'}]}]}, {'title': '2 Month post test data', 'categories': [{'measurements': [{'value': '.780', 'spread': '.9724', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.003', 'groupIds': ['OG000'], 'groupDescription': 'linear trend over time for effect of LED treatments', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Univariate, one-way, repeated measure ANOVA with trend analysis', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment', 'description': 'California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.', 'unitOfMeasure': '# of SD Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in Real Intervention Group'}, {'type': 'PRIMARY', 'title': 'California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial LED Treatment', 'description': 'Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.'}], 'classes': [{'title': 'Pre-test data', 'categories': [{'measurements': [{'value': '-1.136', 'spread': '1.4334', 'groupId': 'OG000'}]}]}, {'title': '1 Week post test data', 'categories': [{'measurements': [{'value': '-0.136', 'spread': '1.1851', 'groupId': 'OG000'}]}]}, {'title': '1 Month post test data', 'categories': [{'measurements': [{'value': '-0.200', 'spread': '1.249', 'groupId': 'OG000'}]}]}, {'title': '2 Month post test data', 'categories': [{'measurements': [{'value': '0.050', 'spread': '1.15', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.006', 'groupIds': ['OG000'], 'groupDescription': 'linear trend over time for the effects of LED treatments', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Univariate, one-way, repeated measure ANOVA with trend analysis', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment', 'description': 'California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.', 'unitOfMeasure': '# of SD Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in Transcranial LED Treatment Group'}, {'type': 'PRIMARY', 'title': 'Controlled Oral Word Association Test (FAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial LED Treatment', 'description': 'All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.\n\nMedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.'}], 'classes': [{'title': 'Pre-test data', 'categories': [{'measurements': [{'value': '-.318', 'spread': '1.54', 'groupId': 'OG000'}]}]}, {'title': '1 Week post test data', 'categories': [{'measurements': [{'value': '.136', 'spread': '1.45', 'groupId': 'OG000'}]}]}, {'title': '1 Month post test data', 'categories': [{'measurements': [{'value': '.114', 'spread': '1.58', 'groupId': 'OG000'}]}]}, {'title': '2 Month post test data', 'categories': [{'measurements': [{'value': '.285', 'spread': '1.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment', 'description': 'Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.', 'unitOfMeasure': '# of SD units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the Transcranial LED Treatment Group'}, {'type': 'PRIMARY', 'title': 'Digit Span, Forwards and Backwards', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial LED Treatment', 'description': 'Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.'}], 'classes': [{'title': 'Pre-test data', 'categories': [{'measurements': [{'value': '-.182', 'spread': '1.45', 'groupId': 'OG000'}]}]}, {'title': '1 Week post test data', 'categories': [{'measurements': [{'value': '.318', 'spread': '1.31', 'groupId': 'OG000'}]}]}, {'title': '1 Month post test data', 'categories': [{'measurements': [{'value': '.444', 'spread': '1.42', 'groupId': 'OG000'}]}]}, {'title': '2 Month post test data', 'categories': [{'measurements': [{'value': '.650', 'spread': '1.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment', 'description': 'Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.', 'unitOfMeasure': '# of SD units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the Transcranial LED Treatment Group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transcranial LED Treatment', 'description': 'Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Recruitment for the study began in April 2010. Potential subjects were recruited through several different methods - Spaulding Rehabilitation Hospital outpatient clinic, advertisements in local area newspapers, Brain Injury Association of MA and other area organizations that provide services to TBI survivors, flyers, on-line and social media.', 'preAssignmentDetails': '22 study subjects signed the consent but only 11 completed the study. The 11 that did not completed the study either did not meet the inclusion criteria at Screening or were lost to follow-up after they screened for the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Transcranial LED Treatment', 'description': 'All study subjects received LED treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy. Each session was 30 minutes in duration. Neuropsychological testing was administered at the following time points: within 1 week of the first LED treatment and within 1 week, 1 month \\& 2 months following the last LED treatment.\n\nThe neuropsychological testing included: 1)Stroop test, 2) California Verbal Learning Test-II (CVLT- II), Short Delay Free \\& Cued Recall, Long Delay Free \\& Cued Recall, 3) Delis-Kaplan Executive Function (D-KEF) -Trails Test, 4) Controlled Oral Word Association Test (FAS), \\& 5) Digit Span, Forwards \\& Backwards.\n\nThe following tests were not analyzed due to collinearity with other measures (r \\> .8): Short Delay Free \\& Cued Recall, Long Delay Cued Recall, \\& Delis-Kaplan Executive Function (D-KEF) -Trails Test.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time Post TBI', 'classes': [{'categories': [{'measurements': [{'value': '3.12', 'spread': '2.50', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'This calculates the time elapsed since injury', 'unitOfMeasure': 'years post TBI', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Years of Education', 'classes': [{'categories': [{'measurements': [{'value': '15.72', 'spread': '2.97', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Numbers of years of education', 'unitOfMeasure': 'Years of Education', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-23', 'studyFirstSubmitDate': '2012-05-04', 'resultsFirstSubmitDate': '2016-05-16', 'studyFirstSubmitQcDate': '2012-05-10', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-12', 'studyFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroop Test for Executive Function - Trial 3 - Inhibition', 'timeFrame': 'Baseline and 1-Week, 1-month and 2-months after final LED Treatment', 'description': 'Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.'}, {'measure': 'Stroop Test for Executive Function - Trial 4 Inhibition Switching', 'timeFrame': 'Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment', 'description': 'Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.'}, {'measure': 'California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5', 'timeFrame': 'Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment', 'description': 'California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.'}, {'measure': 'California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall', 'timeFrame': 'Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment', 'description': 'California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.'}, {'measure': 'Controlled Oral Word Association Test (FAS)', 'timeFrame': 'Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment', 'description': 'Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.'}, {'measure': 'Digit Span, Forwards and Backwards', 'timeFrame': 'Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment', 'description': 'Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mild traumatic brain injury', 'mild TBI', 'mTBI'], 'conditions': ['Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '21172691', 'type': 'RESULT', 'citation': 'Hashmi JT, Huang YY, Osmani BZ, Sharma SK, Naeser MA, Hamblin MR. Role of low-level laser therapy in neurorehabilitation. PM R. 2010 Dec;2(12 Suppl 2):S292-305. doi: 10.1016/j.pmrj.2010.10.013.'}, {'pmid': '21182447', 'type': 'RESULT', 'citation': 'Naeser MA, Saltmarche A, Krengel MH, Hamblin MR, Knight JA. Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports. Photomed Laser Surg. 2011 May;29(5):351-8. doi: 10.1089/pho.2010.2814. Epub 2010 Dec 23.'}], 'seeAlsoLinks': [{'url': 'http://pmr.hms.harvard.edu/pages/10/119/', 'label': 'Department of Physical Medicine and Rehabilitation at Spaulding Hospital - Research'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate whether transcranial, high-intensity LED placed on the scalp can improve working memory in people who have sustained a concussion with lingering effects or a mild brain injury.', 'detailedDescription': "This is a four month, outpatient, single center study investigating whether transcranial, high intensity LED applied outside the skull can improve frontal lobe executive function and working memory in participants with chronic, mild Traumatic Brain Injury (TBI), with or without mild posttraumatic stress disorder (PTSD), due to closed head injury.\n\nParticipants will sign the Informed Consent Form(ICF) before Neuropsychological Screening test are administered. If the participant's neuropsychological screening test scores meet the Inclusion/Exclusion criteria and the participant meets the other Inclusion/Exclusion criteria, then he/she will be tested again on the tests that are part of the Neuropsychological Outcome Measures, the week before the Transcranial LED treatments, and during the week after the last LED treatment and again at one and two months after the last LED treatment. Treatment with Transcranial LED will be for 6 weeks. Participants will be treated three times per week: Monday, Wednesday and Friday. A total of 18 Transcranial LED treatments will be administered."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, Ages 18-65\n* sustained a mild traumatic brain injury(mTBI) at least 6 months ago\n* mTBI is defined as \\< 30 minutes loss of consciousness and \\<30 minutes, post trauma amnesia\n* since the injury patient continues having problems with memory and thinking ability\n\nExclusion Criteria:\n\n* Younger than 18 or older than 65\n* mTBI occured less than 6 months ago\n* moderate to severe Traumatic Brain Injury (TBI)\n* non-closed head injury\n* presence of craniotomy, craniectomy, or ventriculoperitoneal shunt\n* Non-English speaking subjects - Neuropsychological Tests only in English\n* Neuropsychological Screening Test Scores not at least 2 SD below norm on one of the neuropsychological tests or not 1 SD below norm on at least two of the tests administered during screening)'}, 'identificationModule': {'nctId': 'NCT01598532', 'acronym': 'LED', 'briefTitle': 'Effects of LEDs on Memory in TBI Patients', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'Treatment of Cognitive Dysfunction in Mild TBI With Transcranial Light Emitting Diodes- An Open Protocol, Pilot Study', 'orgStudyIdInfo': {'id': '2009-P-001552'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial LED Treatment', 'description': 'All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.', 'interventionNames': ['Device: MedX Health Phototherapy (light therapy)']}], 'interventions': [{'name': 'MedX Health Phototherapy (light therapy)', 'type': 'DEVICE', 'description': 'The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.', 'armGroupLabels': ['Transcranial LED Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Ross D Zafonte, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spaulding Rehabilitation Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President Medical Affairs, Research and Education Spaulding Rehabilitation Network', 'investigatorFullName': 'Ross D. Zafonte, MD', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}