Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-05 @ 8:47 AM
Study NCT ID:
NCT02615535
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058765', 'term': 'Neurofeedback'}], 'ancestors': [{'id': 'D001676', 'term': 'Biofeedback, Psychology'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ginger.polich@mgh.harvard.edu', 'phone': '617 952 5000', 'title': 'Dr. Ginger Polich', 'organization': 'Spaulding Rehabilitation Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse effects from meditation were not anticipated. Subjects practiced meditation for six weeks each. If adverse effects occurred during the six weeks, they contacted our group. At our post-intervention assessment at six weeks, we asked specifically about adverse events. Adverse events were not monitored beyond the intervention period of six weeks.', 'description': 'Definitions are consistent.', 'eventGroups': [{'id': 'EG000', 'title': 'EEG Neurofeedback-assisted Meditation', 'description': 'EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.\n\nEEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-EEG Feedback-assisted Meditation', 'description': 'Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.\n\nNon-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Neurobehavioral Symptom Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EEG Neurofeedback-assisted Meditation', 'description': 'EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.\n\nEEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status'}, {'id': 'OG001', 'title': 'Non-EEG Feedback-assisted Meditation', 'description': 'Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.\n\nNon-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '35.2', 'spread': '3', 'groupId': 'OG000'}, {'value': '33.1', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': '6 weeks', 'categories': [{'measurements': [{'value': '27.7', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and six weeks', 'description': 'Measures common symptoms after head injury. This scales ranges from 0-4 on 22 items, for a minimum score of 0 and a maximum score of 88. Higher scores mean a greater severity of symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Wechsler Adult Intelligence Scale-IV Digit Span', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EEG Neurofeedback-assisted Meditation', 'description': 'EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.\n\nEEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status'}, {'id': 'OG001', 'title': 'Non-EEG Feedback-assisted Meditation', 'description': 'Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.\n\nNon-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '10.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'six weeks', 'categories': [{'measurements': [{'value': '10.9', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and six weeks', 'description': 'Tests participants digit span, repeating forward sequences of digits from 2 to 8. Scale ranges from 0 to 16. Higher scores mean a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EEG Neurofeedback-assisted Meditation', 'description': 'EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.\n\nEEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status'}, {'id': 'OG001', 'title': 'Non-EEG Feedback-assisted Meditation', 'description': 'Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.\n\nNon-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '11.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'six weeks', 'categories': [{'measurements': [{'value': '13.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and six weeks', 'description': 'A subject is provided with a key matching nine numbers to nine unique symbols. Numbers are then provided in random order and subjects have 120 seconds to match as many numbers with symbols as possible. All correct responses are scored. Scores range from 0 to 135. Scores are later scaled from 1 to 19. Higher scores mean a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Trail Making Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EEG Neurofeedback-assisted Meditation', 'description': 'EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.\n\nEEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status'}, {'id': 'OG001', 'title': 'Non-EEG Feedback-assisted Meditation', 'description': 'Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.\n\nNon-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '10.9', 'spread': '1', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'six weeks', 'categories': [{'measurements': [{'value': '12.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and six weeks', 'description': 'Subjects are asked to sequence numbers and letters represented on a page as quickly as then can. Results are measured in seconds, ranging from 0 (hypothetically) to an infinite number (hypothetically). Results are scaled from 1 to 19. Lower scores mean a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Beck Anxiety Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EEG Neurofeedback-assisted Meditation', 'description': 'EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.\n\nEEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status'}, {'id': 'OG001', 'title': 'Non-EEG Feedback-assisted Meditation', 'description': 'Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.\n\nNon-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '15.9', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'six weeks', 'categories': [{'measurements': [{'value': '11.5', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and six weeks', 'description': 'Subjects rate on a 0-3 likert scales responses to questions about anxiety. Scores range from 0-63. Lower scores mean a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Beck Depression Inventory-II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EEG Neurofeedback-assisted Meditation', 'description': 'EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.\n\nEEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status'}, {'id': 'OG001', 'title': 'Non-EEG Feedback-assisted Meditation', 'description': 'Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.\n\nNon-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '19.9', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '17', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'six weeks', 'categories': [{'measurements': [{'value': '13.1', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and six weeks', 'description': 'Subjects respond to questions on a Likert scale from 0-3 regarding depressive symptoms. There are 21 items. Scores range from 0-63. Lower scores mean a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive and Affective Mindfulness Scale-Revised', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EEG Neurofeedback-assisted Meditation', 'description': 'EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.\n\nEEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status'}, {'id': 'OG001', 'title': 'Non-EEG Feedback-assisted Meditation', 'description': 'Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.\n\nNon-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '24.2', 'spread': '2', 'groupId': 'OG000'}, {'value': '24.7', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'six weeks', 'categories': [{'measurements': [{'value': '27.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '28.3', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and six weeks', 'description': 'Subjects answer questions regarding mindfulness on a Likert Scale from 1-4. There are twelve questions total. Scores range from 4-48. Higher scores mean a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EEG Neurofeedback-assisted Meditation', 'description': 'EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.\n\nEEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status'}, {'id': 'OG001', 'title': 'Non-EEG Feedback-assisted Meditation', 'description': 'Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.\n\nNon-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '49.7', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '32', 'spread': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'six weeks', 'categories': [{'measurements': [{'value': '57.7', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '43.7', 'spread': '9.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and at six weeks', 'description': 'Change in "percent Calm" as determined by Muse device. Equations behind this algorithm to determine "Calm" are proprietary and were not shared by the device manufacturer. Ranges from 0% to 100%. Higher scores mean a better outcome.', 'unitOfMeasure': 'percentage of "Calm"', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EEG Neurofeedback-assisted Meditation', 'description': 'EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.\n\nEEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status'}, {'id': 'FG001', 'title': 'Non-EEG Feedback-assisted Meditation', 'description': 'Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.\n\nNon-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'EEG Neurofeedback-assisted Meditation', 'description': 'EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.\n\nEEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status'}, {'id': 'BG001', 'title': 'Non-EEG Feedback-assisted Meditation', 'description': 'Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.\n\nNon-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.3', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '41.4', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '45.4', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-01', 'size': 185972, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-04T10:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2015-11-18', 'resultsFirstSubmitDate': '2019-08-09', 'studyFirstSubmitQcDate': '2015-11-24', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-19', 'studyFirstPostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Neurobehavioral Symptom Inventory', 'timeFrame': 'baseline and six weeks', 'description': 'Measures common symptoms after head injury. This scales ranges from 0-4 on 22 items, for a minimum score of 0 and a maximum score of 88. Higher scores mean a greater severity of symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change in Wechsler Adult Intelligence Scale-IV Digit Span', 'timeFrame': 'baseline and six weeks', 'description': 'Tests participants digit span, repeating forward sequences of digits from 2 to 8. Scale ranges from 0 to 16. Higher scores mean a better outcome.'}, {'measure': 'Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding', 'timeFrame': 'baseline and six weeks', 'description': 'A subject is provided with a key matching nine numbers to nine unique symbols. Numbers are then provided in random order and subjects have 120 seconds to match as many numbers with symbols as possible. All correct responses are scored. Scores range from 0 to 135. Scores are later scaled from 1 to 19. Higher scores mean a better outcome.'}, {'measure': 'Change in Trail Making Test', 'timeFrame': 'baseline and six weeks', 'description': 'Subjects are asked to sequence numbers and letters represented on a page as quickly as then can. Results are measured in seconds, ranging from 0 (hypothetically) to an infinite number (hypothetically). Results are scaled from 1 to 19. Lower scores mean a better outcome.'}, {'measure': 'Change in Beck Anxiety Inventory', 'timeFrame': 'baseline and six weeks', 'description': 'Subjects rate on a 0-3 likert scales responses to questions about anxiety. Scores range from 0-63. Lower scores mean a better outcome.'}, {'measure': 'Change in Beck Depression Inventory-II', 'timeFrame': 'baseline and six weeks', 'description': 'Subjects respond to questions on a Likert scale from 0-3 regarding depressive symptoms. There are 21 items. Scores range from 0-63. Lower scores mean a better outcome.'}, {'measure': 'Change in Cognitive and Affective Mindfulness Scale-Revised', 'timeFrame': 'baseline and six weeks', 'description': 'Subjects answer questions regarding mindfulness on a Likert Scale from 1-4. There are twelve questions total. Scores range from 4-48. Higher scores mean a better outcome.'}, {'measure': 'Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device', 'timeFrame': 'baseline and at six weeks', 'description': 'Change in "percent Calm" as determined by Muse device. Equations behind this algorithm to determine "Calm" are proprietary and were not shared by the device manufacturer. Ranges from 0% to 100%. Higher scores mean a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['traumatic brain injury'], 'conditions': ['Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '24109463', 'type': 'BACKGROUND', 'citation': 'Brandmeyer T, Delorme A. Meditation and neurofeedback. Front Psychol. 2013 Oct 7;4:688. doi: 10.3389/fpsyg.2013.00688. eCollection 2013. No abstract available.'}, {'pmid': '21183265', 'type': 'BACKGROUND', 'citation': 'Chiesa A, Calati R, Serretti A. Does mindfulness training improve cognitive abilities? A systematic review of neuropsychological findings. Clin Psychol Rev. 2011 Apr;31(3):449-64. doi: 10.1016/j.cpr.2010.11.003. Epub 2010 Dec 1.'}, {'pmid': '21440699', 'type': 'BACKGROUND', 'citation': 'Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.'}, {'pmid': '20350028', 'type': 'BACKGROUND', 'citation': 'Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.'}, {'pmid': '32783645', 'type': 'DERIVED', 'citation': 'Polich G, Gray S, Tran D, Morales-Quezada L, Glenn M. Comparing focused attention meditation to meditation with mobile neurofeedback for persistent symptoms after mild-moderate traumatic brain injury: a pilot study. Brain Inj. 2020 Aug 23;34(10):1408-1415. doi: 10.1080/02699052.2020.1802781. Epub 2020 Aug 12.'}]}, 'descriptionModule': {'briefSummary': 'Spaulding Rehabilitation Hospital is conducting a research study evaluating the effectiveness of the brain-training product, MUSE, an EEG-guided neurofeedback device designed to assist in cultivating a relaxed, attentive state of mind during meditation. The investigators study aims to evaluate whether such a tool could be useful in treating persistent traumatic brain injury symptoms such as inattention, impulsivity, irritability, or dysregulated mood.', 'detailedDescription': 'Twenty subjects in total will participate in this study. Subjects will be randomized to focused-attention meditation training with or without the neurofeedback device, MUSE. Subjects will be asked to practice \\~10 min of daily meditation for 6-8 weeks. Neuropsychological testing will be performed at the beginning of the study and after six weeks of training. At this time point, those randomized to the non-MUSE group will be given a device and asked to train for an additional two weeks. At the conclusion of the study, all subjects will also undergo a brief telephone or in-person exit interview regarding their experiences using the MUSE device.\n\nPrimary endpoint: change in Neurobehavioral Symptom Inventory\n\nSecondary endpoints: change in the following: Wechsler Adult Intelligence Scale-IV Digit Span and Symbol-Digit Coding, Trail-Making Test, Beck Anxiety Inventory, Beck Depression Inventory, Cognitive and Affective Mindfulness Scale-Revised, percentage of EEG activity associated with alpha, beta, or theta activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. history of mild-moderate traumatic brain injury\n2. impaired attention or concentration\n3. \\>1 year since traumatic brain injury\n4. ability to participate in neurofeedback and mindfulness meditation\n5. daily access to a smart phone\n6. on stable dosage of neuropsychological medications with no significant changes planned for the duration of the study\n7. no prior history of a meditation practice\n\nExclusion Criteria:\n\n1. severe mental illness or psychological symptoms (severe depression, suicidality, disabling anxiety, PTSD, psychosis, dissociation)\n2. significant pre-morbid learning disability\n3. current or recent (in past year) history of significant drug or alcohol abuse\n4. medical illness severe enough to result in an attentional disorder\n5. neurodegenerative disease\n6. non-fluency in English.'}, 'identificationModule': {'nctId': 'NCT02615535', 'briefTitle': 'Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'Neurofeedback-enhanced Mindfulness Meditation for the Treatment of Affective and Attentional Disturbances in Patients With Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '2015P002184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EEG neurofeedback-assisted meditation', 'description': 'EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.', 'interventionNames': ['Device: EEG neurofeedback-assisted meditation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-EEG feedback-assisted meditation', 'description': 'Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.', 'interventionNames': ['Device: Non-EEG feedback-assisted meditation']}], 'interventions': [{'name': 'EEG neurofeedback-assisted meditation', 'type': 'DEVICE', 'otherNames': ['MUSE'], 'description': 'meditation with auditory feedback regarding EEG status', 'armGroupLabels': ['EEG neurofeedback-assisted meditation']}, {'name': 'Non-EEG feedback-assisted meditation', 'type': 'DEVICE', 'otherNames': ['MUSE without EEG feedback'], 'description': 'meditation without auditory feedback regarding EEG status', 'armGroupLabels': ['Non-EEG feedback-assisted meditation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Charlestown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Hospital Boston', 'geoPoint': {'lat': 42.37787, 'lon': -71.062}}], 'overallOfficials': [{'name': 'Mel B Glenn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spaulding Rehabilitation Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'If participants request their outcome data, we will provide this to them with a brief discussion of its meaning and limitations on interpretation.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'InteraXon, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Outpatient and Community Brain Injury Rehabilitation', 'investigatorFullName': 'Mel B. Glenn', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}