Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-27 @ 4:10 PM
Study NCT ID:
NCT04252261
Status:
UNKNOWN
Last Update Posted:
2020-05-19
First Post:
2020-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Sulforaphane on Cognitive Function in Patients With Frontal Brain Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C016766', 'term': 'sulforaphane'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and researchers are blind to the treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-17', 'studyFirstSubmitDate': '2020-01-27', 'studyFirstSubmitQcDate': '2020-01-31', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline cognitive tests scores at 3 months', 'timeFrame': 'Week 1 and week 12.', 'description': 'The battery of cognitive tests include different domains of cognitive tests, higher scores indicates better cognition.'}], 'secondaryOutcomes': [{'measure': 'the resting state MRI (rsMRI)', 'timeFrame': 'Week 0 and 12.', 'description': 'It can be served as a powerful tool to map networks of "functional connectivity" in the brain even in the absence of task activation or stimulation.'}, {'measure': 'T1-weighted spin-echo MRI', 'timeFrame': 'Week 0, 4, and 12.', 'description': 'It can be used as outcome measures in therapeutic trials'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sulforaphane', 'frontal brain damage', 'cognitive deficits', 'cognitive function', 'brain metabolites', 'gut microbiota'], 'conditions': ['Frontal Lobe Dysfunction']}, 'referencesModule': {'references': [{'pmid': '33067279', 'type': 'DERIVED', 'citation': 'Liu F, Huang J, Hei G, Wu R, Liu Z. Effects of sulforaphane on cognitive function in patients with frontal brain damage: study protocol for a randomised controlled trial. BMJ Open. 2020 Oct 16;10(10):e037543. doi: 10.1136/bmjopen-2020-037543.'}]}, 'descriptionModule': {'briefSummary': 'High rates of patients with frontal brain damage show serious cognitive functional deficits, which negatively impact their quality of life and are linked with poor clinical outcomes. Sulforaphane has shown significant antioxidant and cellular protective effects in animal models associated with oxidative stress, such as focal cerebral ischemia, brain inflammation, and intracranial hemorrhage. Preclinical research has shown that sulforaphane can significantly improve spatial localization and working memory impairment after brain damage. The primary aim of this clinical trial is to assess the efficacy of sulforaphane for improving cognitive function in patients with frontal brain damage.', 'detailedDescription': '90 patients aged 18-65 years, of both genders, who have incurred cognitive deficits after frontal brain damage will be recruited in the neurosurgery department in Xiangya hospital. All focal lesions were confined to the frontal brain, which is verified by CT or MRI. Cognitive deficits will be diagnosed using the Chinese version of the Montreal Cognitive Assessment (MoCA-C). All eligible recruited patients will be randomly divided into two groups in a 2:1 ratio. Participants will receive a battery of cognitive tests at baseline and again after 4 and 12 weeks to determine the effect of sulforaphane on cognition. T1-weighted brain magnetic resonance images and resting-state functional MRI will be carried out using 3 Tesla (3T) brain MRI at these timepoints. Brain magnetic resonance spectrum will be applied to detect MRI markers of brain metabolites and gut microbiota will also be assessed over this period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old\n* Focal lesions were confined to the frontal brain, which is verified by CT or MRI\n* Clinical diagnosis of Cognitive deficits using the Chinese version of the Montreal Cognitive Assessment (MoCA-C) with scores \\< 26 will be assessed as having cognitive deficits (\\<25 for patients educated \\<12 years)\n* be adherent to the continued sulforaphane treatment medication\n\nExclusion Criteria:\n\n* Previous history of cognitive impairment\n* Brain MRI indicating damage was not restricted to the frontal lobe.\n* Inability to cooperate with cognitive testing for disturbance of consciousness or mental disorder\n* Pregnancy or maternal lactation\n* Life expectancy \\< 3 months\n* CO poisoning, autoimmune encephalitis, intracranial infection, or other types of diffuse intracranial disease.\n* plan to receive radiotherapy during the trial period\n* Laboratory examination showing liver and kidney insufficiency or other severe complications; the presence of diseases which may interfere with the results of the evaluation\n* Involvement in other trials 1 month prior to the start of the trial or during the trial period'}, 'identificationModule': {'nctId': 'NCT04252261', 'briefTitle': 'Effects of Sulforaphane on Cognitive Function in Patients With Frontal Brain Damage', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': 'Effects of Sulforaphane on Cognitive Function in Patients With Frontal Brain Damage: Study Protocol for a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '202001005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sulforaphane', 'description': 'To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage', 'interventionNames': ['Drug: sulforaphane']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage', 'interventionNames': ['Drug: placedo']}], 'interventions': [{'name': 'sulforaphane', 'type': 'DRUG', 'description': 'To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage', 'armGroupLabels': ['sulforaphane']}, {'name': 'placedo', 'type': 'DRUG', 'description': 'To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhixiong Liu', 'role': 'CONTACT', 'email': 'zhixiongliu@csu.edu.cn', 'phone': '+8615874290600'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': '2021-2022', 'ipdSharing': 'YES', 'description': 'The study protocol and informed consent form are available on request to the corresponding author.', 'accessCriteria': 'The sharing data for this study are available on request to the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}