Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT04295720
Status:
TERMINATED
Last Update Posted:
2023-03-03
First Post:
2020-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Post-Chemo Cognitive Impairment w/Transcranial Magnetic Stimulation (Chemobrain TMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084202', 'term': 'Chemotherapy-Related Cognitive Impairment'}], 'ancestors': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pkuo@arizona.edu', 'phone': '520-626-1957', 'title': 'Phillip H. Kuo, MD, PhD', 'organization': 'University of Arizona'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '14 days', 'description': 'Adverse events were monitored/assessed beginning at initiation of treatment (day 1) through treatment completion, 14 days. Adverse events were monitored by Non-Systematic Assessment method; self-reported by participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Transcranial Magnetic Stimulation (TMS)', 'description': 'We propose to test the efficacy of rTMS for the treatment of PCCI. Efficacy measures will include baseline and post-rTMS neuropsychological testing, functional MRI and biometry data using body worn sensors.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Memory Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Magnetic Stimulation (TMS)', 'description': 'Efficacy measures will include baseline and post-rTMS neuropsychological testing, functional MRI and biometry data using body worn sensors.\n\nThis is an open label trial with only a treatment arm (no placebo group).'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': 'NA', 'comment': 'Standard Deviation is not calculable for 1 participant', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'Efficacy measures will include baseline and post-rTMS neuropsychological testing. The Outcome Measure is the difference between the pre and post scores of the following Neuropsychological tests. The score from each test was added together to come up with a single value.\n\nA higher score indicates better performance. Minimum is score of 0 and maximum is not applicable (a timed test).\n\nThe Neuropsychological tests we analyzed:\n\nForward Digit Span Backward Digit Span Rey Auditory Verbal Learning Test Verbal Fluency Task Stroop Color-Word Interference Task', 'unitOfMeasure': 'items recalled correctly', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant was analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transcranial Magnetic Stimulation (TMS)', 'description': "We propose to test the efficacy of rTMS for the treatment of PCCI. Efficacy measures will include baseline and post-rTMS neuropsychological testing, functional MRI and biometry data using body worn sensors.\n\nTranscranial magnetic stimulation (TMS): Subjects will undergo testing at baseline prior to TMS treatments and once more at the end of the 2-week intervention.After the conclusion of baseline data acquisition, the research team will analyze each participant's unique structural and functional connectivity patterns to determine stimulation site for TMS in future study sessions.\n\nThe subjects will receive 10-sessions (1 session per day, M-F over 2 consecutive weeks).\n\nThe treatment itself lasts approximately only 190 seconds."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Transcranial Magnetic Stimulation (TMS)', 'description': "We propose to test the efficacy of rTMS for the treatment of PCCI. Efficacy measures will include baseline and post-rTMS neuropsychological testing, functional MRI and biometry data using body worn sensors.\n\nTranscranial magnetic stimulation (TMS): Subjects will undergo testing at baseline prior to TMS treatments and once more at the end of the 2-week intervention. After the conclusion of baseline data acquisition, the research team will analyze each participant's unique structural and functional connectivity patterns to determine stimulation site for TMS in future study sessions."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', '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': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'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': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Neuropsychological testing', 'classes': [{'categories': [{'measurements': [{'value': '130', 'spread': 'NA', 'comment': 'Standard Deviation is not calculable for 1 participant', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Baseline Measure is the combined score of the following Neuropsychological tests prior to the treatment. The score from each test was added together to come up with a single value for comparison with the post treatment assessments.\n\nA higher score indicates better performance. Minimum is score of 0 and maximum is not applicable (timed test).\n\nThe Neuropsychological tests we analyzed:\n\nForward Digit Span Backward Digit Span Rey Auditory Verbal Learning Test Verbal Fluency Task Stroop Color-Word Interference Task', 'unitOfMeasure': 'total number of items recalled correctly', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-03', 'size': 323372, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-19T17:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '12 participants with PCCI will be recruited to participate in this trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Stopped due to the risk of COVID-19 variants to our subject base of cancer patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2020-02-27', 'resultsFirstSubmitDate': '2022-12-19', 'studyFirstSubmitQcDate': '2020-03-02', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-28', 'studyFirstPostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Memory Testing', 'timeFrame': '14 days', 'description': 'Efficacy measures will include baseline and post-rTMS neuropsychological testing. The Outcome Measure is the difference between the pre and post scores of the following Neuropsychological tests. The score from each test was added together to come up with a single value.\n\nA higher score indicates better performance. Minimum is score of 0 and maximum is not applicable (a timed test).\n\nThe Neuropsychological tests we analyzed:\n\nForward Digit Span Backward Digit Span Rey Auditory Verbal Learning Test Verbal Fluency Task Stroop Color-Word Interference Task'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Chemo-brain', 'Post-Chemotherapy cognitive impairment', 'PCCI', 'Transcranial magnetic stimulation', 'TMS'], 'conditions': ['Chemo-brain']}, 'descriptionModule': {'briefSummary': 'In this pilot study, the investigators propose to test the efficacy of rTMS for the treatment of PCCI. Efficacy measures will include baseline and post-rTMS neuropsychological testing, functional MRI and biometry data using body worn sensors.', 'detailedDescription': 'Transcranial magnetic stimulation (TMS) is a safe and non-invasive brain stimulation technique. It uses a magnetic coil to stimulate brain tissue painlessly using only a magnet (no electrodes or electrical wires) in a procedure that does not involve any surgery or sedation. TMS is currently FDA approved to treat depression and migraines. Although this technology is applicable to many other brain conditions as well, it has not been systematically examined in individuals with "Chemo-brain". Chemo-brain or Post-Chemotherapy Cognitive Impairment (PCCI) is defined as cognitive changes including impairment of memory, learning, concentration, reasoning, executive function, attention and visuo visio-spatial skills that occur during or after chemotherapy treatment.\n\nIn this study, investigators will:\n\n1. use high-resolution magnetic resonance imaging (MRI) of individuals\' brains to determine precisely where to place the TMS magnetic coil in order to stimulate the target brain region based off their unique brain structure.\n2. use TMS to stimulate the target region of the brain.\n3. take high-resolution MRI pictures of the brain both baseline and post-TMS to study whether the brain activity of the target region changes as a result of the TMS stimulation.\n4. perform neuropsychological tasks baseline and post-TMS to study if performance is improved following stimulation of the target brain region.\n5. collect data from completing Frailty assessments, baseline and post-TMS.\n6. study the short-term and long-term treatment effects.\n7. collect subject\'s daily activity and sleep/wake patterns from watch style device (http://www.actigraphy.com/solutions/actiwatch/actiwatch-plus-specifications.html).\n8. perform behavioral assessments, baseline and post-TMS, to study whether there are measurable changes following stimulation of the target brain region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\>=18).\n* PCCI diagnosis (see information below).\n* Right Handed (We will not enroll left-handed dominant people because they tend to have more symmetric brain function and thus targeting the left frontal region may not be as effective.)\n* English speaking.\n* Cancer treatment completed and considered curative with the exception of endocrine therapy after chemotherapy.\n* Able to attend daily intervention (Monday-Friday) for 2 weeks.\n* Not enrolled in another interventional study within 6 months prior to beginning this study.\n\nExclusion Criteria:\n\n* Pregnancy or thinking of becoming pregnant.\n* Undergoing active treatment for cancer.\n* Routine contraindications for MRI (including incompatible medical implants or metal fragments in the body at risk for migration or heating with application of the magnetic field) including severe claustrophobia.\n* History of brain metastasis or other brain tumor.\n* History of stroke or traumatic brain injury.\n* Frequent or severe headaches.\n* Cognitive or mood disorder prior to chemotherapy (i.e. dementia or depression).\n* History of epilepsy, or other seizure disorders.\n* History mental health disorders, such as substance misuse, bipolar disorder or psychosis.\n* Taking medication for seizures or that could lower seizure threshold if withdrawn.\n* Inability to complete neuropsychological testing.\n* Prior treatment with rTMS. We will enroll subjects without prior experience with rTMS.'}, 'identificationModule': {'nctId': 'NCT04295720', 'briefTitle': 'Treatment of Post-Chemo Cognitive Impairment w/Transcranial Magnetic Stimulation (Chemobrain TMS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Treatment of Post-Chemotherapy Cognitive Impairment With Transcranial Magnetic Stimulation (Chemobrain TMS)', 'orgStudyIdInfo': {'id': '1911180572'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial magnetic stimulation (TMS)', 'description': 'We propose to test the efficacy of rTMS for the treatment of PCCI. Efficacy measures will include baseline and post-rTMS neuropsychological testing, functional MRI and biometry data using body worn sensors.', 'interventionNames': ['Device: Transcranial magnetic stimulation (TMS)']}], 'interventions': [{'name': 'Transcranial magnetic stimulation (TMS)', 'type': 'DEVICE', 'description': "Subjects will undergo testing at baseline prior to TMS treatments and once more at the end of the 2-week intervention.After the conclusion of baseline data acquisition, the research team will analyze each participant's unique structural and functional connectivity patterns to determine stimulation site for TMS in future study sessions.\n\nThe subjects will receive 10-sessions (1 session per day, M-F over 2 consecutive weeks).\n\nThe treatment itself lasts approximately only 190 seconds.", 'armGroupLabels': ['Transcranial magnetic stimulation (TMS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Phillip Kuo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}