Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-06 @ 3:41 AM
Study NCT ID:
NCT04193267
Status:
UNKNOWN
Last Update Posted:
2021-03-22
First Post:
2019-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Magnetic Brain Stimulation Improve Language Function in Primary Progressive Aphasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-10-29', 'releaseDate': '2021-10-01'}], 'estimatedResultsFirstSubmitDate': '2021-10-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018888', 'term': 'Aphasia, Primary Progressive'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001037', 'term': 'Aphasia'}, {'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-19', 'studyFirstSubmitDate': '2019-11-18', 'studyFirstSubmitQcDate': '2019-12-09', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in score on the Druks and Masterson Naming Task', 'timeFrame': 'One week pre- and one week post-rTMS treatment', 'description': 'Assessment of change in language function as a result of rTMS intervention. Minimum score = 0. Maximum score = 24. Higher scores indicate better naming performance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Progressive Aphasia', 'Brain Stimulation'], 'conditions': ['Logopenic Progressive Aphasia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) - a form of non-invasive brain stimulation - to improve language functioning in individuals who have the logopenic variant of primary progressive aphasia (PPA-L) - a slowly progressive impairment of language, characterized by difficulties with word-finding, sentence repetition and sentence comprehension.', 'detailedDescription': 'This study is an open label pilot study that aims to recruit 10 individuals with diagnosed logopenic primary progressive aphasia (PPA-L) to investigate the tolerability and efficacy of using repetitive transcranial magnetic stimulation (rTMS) to improve language functioning in this disorder. rTMS is a non-invasive method of brain stimulation that uses rapid magnetic pulses applied over the scalp to activate neurons in a specified target location of the brain.\n\nA variety of language tests will be administered to participants prior to rTMS treatment as well as following 30 sessions of daily rTMS. Additionally, language testing will be performed during the first session of rTMS treatment in order to assess the effect of simultaneous rTMS administration on language function. Performance on the pre- and post-treatment tests will be compared to determine the effect of rTMS treatment on language abilities.\n\nTreatment will consist of daily sessions of high frequency (10 Hz) rTMS applied over the left temporal gyrus. Patients will receive one session of rTMS per day for 30 consecutive weekdays. Each session will take approximately 45 minutes to complete.\n\nAs a pilot study, this research will be used to evaluate the effect size and the feasibility of a more definitive project in the future. Both patient response and tolerability to rTMS will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of PPA-L (confirmed by a neurologist or neuropsychiatrist who has observed the patient for at least one year);\n* Mild to moderate language impairment as assessed by the Druks and Masterson Naming Task;\n* Native English speaker.\n\nExclusion Criteria:\n\n* Cerebrovascular disorders, hydrocephalus or intra-cranial mass, documented by MRI;\n* History of traumatic brain injury, seizures, or another neurological disease;\n* Significant medical problems (e.g. poorly controlled diabetes or hypertension or cancer within the past 5 years);\n* Major depressive disorder, bipolar disorder, schizophrenia, substance use disorder or mental retardation according to the criteria of the DSM-IV;\n* Any contraindication for rTMS (e.g., implanted metal devices; cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps, metal in the body \\[rods, plates, screws, shrapnel, dentures, IUD\\] or metallic particles in the body, surgical clips in the head, previous neurosurgery, cochlear implants, prosthetic heart valves);\n* Currently pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT04193267', 'briefTitle': 'Can Magnetic Brain Stimulation Improve Language Function in Primary Progressive Aphasia', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'rTMS for the Improvement of Language Functioning in the Logopenic Variant of Primary Progressive Aphasia; a Feasibility and Tolerability Pilot Study', 'orgStudyIdInfo': {'id': 'HS23339 (B2019:108)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Repetitive Transcranial Magnetic Stimulation (rTMS)', 'description': '30 sessions of high-frequency (10Hz) repetitive stimulation applied over the posterior region of the left superior temporal gyrus in patients with logopenic primary progressive aphasia (PPA-L) using a MagStim Rapid2 Transcranial Magnetic Simulation machine.', 'interventionNames': ['Device: MagStim Rapid2 Transcranial Magnetic Simulation']}], 'interventions': [{'name': 'MagStim Rapid2 Transcranial Magnetic Simulation', 'type': 'DEVICE', 'description': 'A non-invasive method of brain stimulation', 'armGroupLabels': ['Repetitive Transcranial Magnetic Stimulation (rTMS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R2H2A6', 'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Benjamin Meek', 'role': 'CONTACT', 'email': 'rtms@sbgh.mb.ca', 'phone': '2042372677'}], 'facility': 'St. Boniface Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'centralContacts': [{'name': 'Benjamin Meek', 'role': 'CONTACT', 'email': 'rtms@sbgh.mb.ca', 'phone': '2042372677'}], 'overallOfficials': [{'name': 'Michelle Tsang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}, {'name': 'Mandana Modirrousta, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Manitoba'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-10-01', 'type': 'RELEASE'}, {'date': '2021-10-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Manitoba'}}}}