Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-31 @ 8:18 PM
Study NCT ID:
NCT04551092
Status:
TERMINATED
Last Update Posted:
2025-11-10
First Post:
2020-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neurofeedback-EEG-VR System for Non-opioid Pain Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gayle@quasarusa.com', 'phone': '858 412 1839', 'title': 'Gayle Guy', 'organization': 'Quantum Applied Science & Research, QUASAR Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'NEVR Study', 'description': 'Single group to receive intervention\n\nNEVR: a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Patients Completing the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NEVR Study', 'description': 'Single group to receive intervention\n\nNEVR: a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 6 months', 'description': 'The researchers will calculate the percentage of patients who complete all 20 sessions of the study without any adverse effects nor any discomfort from the device or VR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Shortly after recruitment commenced, the study site was shut down for COVID and when re-opened it was a vaccine test site. The vaccine tests received priority and the study was not able to be conducted before the project period ended. No subjects completed the protocol and thus analysis was not able to be conducted.'}, {'type': 'PRIMARY', 'title': 'Patient Tolerance of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NEVR Study', 'description': 'Single group to receive intervention\n\nNEVR: a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.'}], 'classes': [{'title': 'Pressure Points', 'categories': [{'measurements': [{'value': '3', 'spread': '.71', 'groupId': 'OG000'}]}]}, {'title': 'Helmet Weight', 'categories': [{'measurements': [{'value': '5.25', 'spread': '1.48', 'groupId': 'OG000'}]}]}, {'title': 'Headset Tightness', 'categories': [{'measurements': [{'value': '6', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Neck Muscle Tightness', 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.66', 'groupId': 'OG000'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '6.5', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Overall Comfort', 'categories': [{'measurements': [{'value': '6.75', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 6 months', 'description': 'The researchers will survey the subjects about their comfort of wearing the device after each session on a scale of 1-10, where 1 is intolerable, 5 is just tolerable, and 10 is most comfortable. The researchers refer to this as the Comfort Scale.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "4 subjects only completed 1 session and no further sessions were conducted. Each subject reported on the 1-10 Comfort Scale for 6 measures. Subjects were asked to rate comfort for each of the 6 items on a scale from 1-10, where 1 was intolerable, 5 was just tolerable and 10 most comfortable. Higher values indicate a better comfort rating for that item. The mean values indicate the mean of the subjects' scores, as the goal is to produce a comprehensive comfort score per subject on a 1-10 scale."}, {'type': 'PRIMARY', 'title': 'Adverse Effect on Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NEVR Study', 'description': 'Single group to receive intervention\n\nNEVR: a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.'}], 'timeFrame': 'up to 6 months', 'description': "Subjects' back pain will be assessed prior to and after the first, 10th and last sessions via the following standardized subjective, objective, behavioral and functional evaluation tests: 1) Numerical Rating Scale (NRS, or Visual Analog Pain Score (VAS), 2) The DALLAS scale; 3) Patient Assessment Global Change. The researchers will compare the before and after session results to determine if the sessions had a negative impact on the patients' perceived pain.", 'reportingStatus': 'POSTED', 'populationDescription': 'The assessments were not conducted prior to and after Session 1 for the 4 subjects who completed one session. The subject testing site was also a COVID treatment and vaccine testing site and the Subject Matter Expert was not available to conduct these assessments. There are no data for this measure.'}, {'type': 'SECONDARY', 'title': 'Changes in Pain Perception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NEVR Study', 'description': 'Single group to receive intervention\n\nNEVR: a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.'}], 'timeFrame': '6 months', 'description': 'The researchers will evaluate changes in pain perception over the course of the 20 sessions as determined by the pain questionnaires listed above. The researchers will plot the changes and calculate the percent change between the first to last measurement.', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 4 subjects completed any sessions and each of these only completed one session. Thus it was not possible to plot a change from session to session. There are no data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Changes in EEG Activity Patterns', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NEVR Study', 'description': 'Single group to receive intervention\n\nNEVR: a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.'}], 'timeFrame': 'up to 6 months', 'description': 'The researchers will calculate synchrony in electroencephalographic (EEG) alpha band (at 10Hz) across the temporal and central electrodes over the course of the 20 sessions. The researchers will compare the percentage of synchrony changes inter- and intra-sessions.', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects completed the protocol. Only 4 subjects did one session each. The data from these subjects were not adequate to conduct this calculation and no further sessions were conducted in which to revise the collection methodology to ensure adequate collection. Comfort survey data were collected but EEG data were not properly saved by the researchers and thus were not usable.'}, {'type': 'SECONDARY', 'title': 'Dose Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NEVR Study', 'description': 'Single group to receive intervention\n\nNEVR: a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.'}], 'timeFrame': 'up to 6 months', 'description': 'The researchers will analyze the relationship between the number of sessions completed and the reported pain score of each of the three pain scales, as well as the EEG alpha synchrony. The research team will calculate a trendline to determine if there is a positive or negative trend and calculate a correlation index.', 'reportingStatus': 'POSTED', 'populationDescription': 'No subjects completed the protocol. No subjects completed more than one session. Calculation not able to be conducted.'}, {'type': 'SECONDARY', 'title': 'Signal Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NEVR Study', 'description': 'Single group to receive intervention\n\nNEVR: a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.'}], 'timeFrame': 'up to 6 months', 'description': 'The researchers will also calculate the percentage of the acquired EEG signal that is deemed to be unusable due to contamination by noise or artifacts (other than EMG or blink artifacts), as defined by regions where the root mean square (RMS) signal amplitude exceeds 100 microV.', 'reportingStatus': 'POSTED', 'populationDescription': 'A researcher error in using the data collection software meant that EEG data for the 4 participants who did one session were not saved properly to be transmitted to QUASAR scientists for analysis. Training for the researcher was rectified once the issue was identified but no more sessions were conducted after that. There are no data for this outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NEVR Study', 'description': 'Single group to receive intervention\n\nNEVR: a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'NEVR Study', 'description': 'Single group to receive intervention\n\nNEVR: a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected about 5 subjects. Signed consent but contact was lost after that.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected for 5 subjects. Subjects signed consent but follow up contact was unsuccessful.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-07', 'size': 337292, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-24T17:16', 'hasProtocol': True}, {'date': '2021-03-06', 'size': 3502165, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-24T17:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Period of performance expired', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-24', 'studyFirstSubmitDate': '2020-07-13', 'resultsFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2020-09-10', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-24', 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Patients Completing the Study', 'timeFrame': 'up to 6 months', 'description': 'The researchers will calculate the percentage of patients who complete all 20 sessions of the study without any adverse effects nor any discomfort from the device or VR.'}, {'measure': 'Patient Tolerance of Device', 'timeFrame': 'up to 6 months', 'description': 'The researchers will survey the subjects about their comfort of wearing the device after each session on a scale of 1-10, where 1 is intolerable, 5 is just tolerable, and 10 is most comfortable. The researchers refer to this as the Comfort Scale.'}, {'measure': 'Adverse Effect on Pain', 'timeFrame': 'up to 6 months', 'description': "Subjects' back pain will be assessed prior to and after the first, 10th and last sessions via the following standardized subjective, objective, behavioral and functional evaluation tests: 1) Numerical Rating Scale (NRS, or Visual Analog Pain Score (VAS), 2) The DALLAS scale; 3) Patient Assessment Global Change. The researchers will compare the before and after session results to determine if the sessions had a negative impact on the patients' perceived pain."}], 'secondaryOutcomes': [{'measure': 'Changes in Pain Perception', 'timeFrame': '6 months', 'description': 'The researchers will evaluate changes in pain perception over the course of the 20 sessions as determined by the pain questionnaires listed above. The researchers will plot the changes and calculate the percent change between the first to last measurement.'}, {'measure': 'Changes in EEG Activity Patterns', 'timeFrame': 'up to 6 months', 'description': 'The researchers will calculate synchrony in electroencephalographic (EEG) alpha band (at 10Hz) across the temporal and central electrodes over the course of the 20 sessions. The researchers will compare the percentage of synchrony changes inter- and intra-sessions.'}, {'measure': 'Dose Response', 'timeFrame': 'up to 6 months', 'description': 'The researchers will analyze the relationship between the number of sessions completed and the reported pain score of each of the three pain scales, as well as the EEG alpha synchrony. The research team will calculate a trendline to determine if there is a positive or negative trend and calculate a correlation index.'}, {'measure': 'Signal Quality', 'timeFrame': 'up to 6 months', 'description': 'The researchers will also calculate the percentage of the acquired EEG signal that is deemed to be unusable due to contamination by noise or artifacts (other than EMG or blink artifacts), as defined by regions where the root mean square (RMS) signal amplitude exceeds 100 microV.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pain Management']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.quasarusa.com', 'label': 'Lead organization website'}, {'url': 'https://actri.ucsd.edu/index.html', 'label': 'Subaward research site'}, {'url': 'http://heal.nih.gov', 'label': 'NIH Funding Initiative'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the feasibility of developing the Neurofeedback-EEG-VR (NEVR) system for non-opioid pain therapy. Subjects suffering from pain will undergo sessions involving VR and Neurofeedback training and their pain will be assessed.', 'detailedDescription': "QUASAR and UCSD are conducting a clinical trial on 25 subjects to evaluate the feasibility of a novel Neurofeedback electroencephalography (EEG) Virtual Reality (VR) system aimed at reducing chronic pain. The NEVR device consists of a dry electrode EEG headset combined with a VR Head-Mounted Display (VR-HMD) device and neurofeedback software. This approach relies on retraining the brain's networks to reduce the perception of pain and does not involve pharmaceutical drugs. Patients with chronic lower back pain will be recruited by UCSD at its Altman Clinical \\& Translational Research Institute. Patients that meet the recruitment criteria will be asked to conduct 20 1-hour long sessions of EEG-based Neurofeedback in VR over the course of a couple of months. Pain assessment and device usability questionnaires will be conducted prior to and after the first and last sessions, and at intermediate time points. This will be a single arm clinical trial aimed at demonstrating the safety and viability of the NEVR device, with the primary outcome measure being the ability of patients to conduct all 20 sessions safely and comfortably. Secondary outcome measures include assessment of changes in pain perception, and of changes in EEG activity patterns."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic back pain that can be of multifactorial etiology inclusive of axial and radicular back pain\n* Report a Numerical Rating Scale (NRS, or Visual Analog Score VAS) score of greater than 6/10\n* Must be willing to for the duration of the study make no pharmacological adjustments or have additional Interventional therapies, as reported by the patient\n* Must have the cognitive capacity to provide consent/assent\n* Must be able to sit up in a chair during the recording session\n* Must demonstrate understanding of the protocol, its purpose and subject participation\n* Must be fluent in English\n\nExclusion Criteria:\n\n* Measured head size too small or too large for the EEG equipment\n* Any significant skull defect\n* History of a recent craniotomy (within the last six months)\n* Any signs of scalp inflammation, irritation, or abnormal skin conditions\n* History of epilepsy or seizures\n* Known allergies to any material to be used in this project\n* Sight disabilities that make participation impractical\n* Hair styles with thick braids or dread locks'}, 'identificationModule': {'nctId': 'NCT04551092', 'acronym': 'NEVR', 'briefTitle': 'Neurofeedback-EEG-VR System for Non-opioid Pain Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Quantum Applied Science & Research, Inc.'}, 'officialTitle': 'Neurofeedback-EEG-VR (NEVR) System for Non-opioid Pain Therapy', 'orgStudyIdInfo': {'id': 'R43DA050380', 'link': 'https://reporter.nih.gov/quickSearch/R43DA050380', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single', 'description': 'Single group to receive intervention', 'interventionNames': ['Device: NEVR']}], 'interventions': [{'name': 'NEVR', 'type': 'DEVICE', 'description': 'a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.', 'armGroupLabels': ['Single']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Altman Clinical and Translational Research Institute', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Walid Soussou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quantum Applied Science & Research (QUASAR), Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quantum Applied Science & Research, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of California, San Diego', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}