Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT04901156
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2021-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
rTMS and Multi-Modality Aphasia Therapy for Post-Stroke Aphasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001039', 'term': 'Aphasia, Broca'}, {'id': 'D001037', 'term': 'Aphasia'}, {'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2021-05-20', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline on the Boston Naming Test within one week of intervention completion', 'timeFrame': 'Baseline, within 1 week of completing the 10 day intervention', 'description': 'Number of spontaneously produced correct responses to a series of line drawings. That is, the number of correctly named images.'}, {'measure': 'Change from baseline on the Boston Naming Test at 3 months', 'timeFrame': 'Baseline and 3-month follow-up', 'description': 'Number of spontaneously produced correct responses to a series of line drawings. That is, the number of correctly named images.'}], 'secondaryOutcomes': [{'measure': 'Trained and Untrained Picture Naming', 'timeFrame': 'Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up', 'description': 'Number of correctly named pictures from a set of trained nouns, trained verbs, untrained nouns, and untrained verbs'}, {'measure': 'Story Narrative Task', 'timeFrame': 'Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up', 'description': 'Retelling of the Cinderella task as a measure of discourse, performance is quantified by number of correct information units.'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up', 'description': 'A 9-item questionnaire completed by a caregiver to quickly assess depressive symptoms. The scale ranges from 0 to 27 with higher scores indicating greater endorsement of depressive symptoms.'}, {'measure': 'EuroQoL-5D-5L', 'timeFrame': 'Baseline, within 1 week of completing the 10 day intervention and 3-month follow-up', 'description': "Assesses mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The answers given can be converted into EQ-5D index with scores anchored at 0 for death and 1 for perfect health. The EQ-5D also records the patient's self-rated health on a vertical visual analogue scale ranging from 0 to 100 with higher scores indicating higher self-perceived quality of life. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-invasive brain stimulation', 'Transcranial Magnetic Stimulation', 'Multi-modality aphasia therapy', 'Neuroimaging', 'Stroke', 'Aphasia', 'Aphasia, Broca', 'Speech Disorders', 'Language Disorders'], 'conditions': ['Stroke', 'Aphasia, Non-fluent']}, 'referencesModule': {'references': [{'pmid': '36525719', 'type': 'RESULT', 'citation': 'Low TA, Lindland K, Kirton A, Carlson HL, Harris AD, Goodyear BG, Monchi O, Hill MD, Dukelow SP. Repetitive transcranial magnetic stimulation (rTMS) combined with multi-modality aphasia therapy for chronic post-stroke non-fluent aphasia: A pilot randomized sham-controlled trial. Brain Lang. 2023 Jan;236:105216. doi: 10.1016/j.bandl.2022.105216. Epub 2022 Dec 14.'}]}, 'descriptionModule': {'briefSummary': "Many stroke survivors experience aphasia, a loss or impairment of language affecting the production or understanding of speech. One common type of aphasia is known as non-fluent aphasia. Patients with non-fluent aphasia have difficulty formulating grammatical sentences, often producing short word fragments despite having a good understanding of what others are trying to communicate to them. Speech language pathologists (SLPs) play a central role rehabilitating persons with aphasia and administer therapy in an attempt to improve communication skills. Despite standard therapy, approximately 50% of individuals who experience aphasia acutely continue to have language deficits more than 6 months post-stroke.\n\nIn most people, Broca's area is dominant in the left side of the brain. Following a left-sided stroke, the right-sided homologue of Broca's area (the pars triangularis), may adopt language function. Unfortunately, reorganizing language to the right side of the brain seems to be less effective than restoring function to the left hemisphere. Repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, can be used to suppress activity of specific regions in the right side of the brain to promote recovery of function in the perilesional area. Despite preliminary success in existing studies using rTMS in post-stroke aphasia, there is much work to be done to better understand the mechanisms underlying recovery. Responses to rTMS have been positive, yet heterogenous, which may be related to timing of treatments following stroke."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Isolated left middle cerebral artery (MCA) stroke more than 6 months ago (chronic)\n* Stroke type: Ischemic or hemorrhagic\n* Non-fluent aphasia as determined by the Western Aphasia Battery (Fluency \\< 5)\n* Right-hand dominant prior to stroke\n* English is first or primary language\n* Ability to follow 3-step commands\n\nExclusion Criteria:\n\n* Prior stroke to the right frontal lobe\n* Current diagnosis of moderate to severe depression\n* Diagnosis of any other psychiatric condition\n* History of other neurologic disorders (e.g., epilepsy, brain tumor)\n* Contraindication to MRI or TMS (metal in the head or any implanted electrical device)\n* Has received intensive speech therapy within the past 6 months (\\>8 hours per week)\n* Enrolled in another interventional study'}, 'identificationModule': {'nctId': 'NCT04901156', 'acronym': 'TMAT', 'briefTitle': 'rTMS and Multi-Modality Aphasia Therapy for Post-Stroke Aphasia', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'A Randomized Pilot Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) and Multi-Modality Aphasia Treatment (M-MAT) for Post-Stroke Non-Fluent Aphasia', 'orgStudyIdInfo': {'id': 'REB17-1014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multi-modality aphasia therapy plus 1Hz rTMS', 'description': 'Chronic stroke patients, receive 10 days of 3.5hrs of multi-modality aphasia therapy (M-MAT) preceded by 20 minutes of 1Hz rTMS delivered at 100% of resting motor threshold over the right pars triangularis.', 'interventionNames': ['Device: 1Hz inhibitory rTMS', 'Behavioral: Multi-Modality Aphasia Therapy (M-MAT)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Multi-modality aphasia therapy plus sham rTMS', 'description': 'Chronic stroke patients, receive 10 days of 3.5hrs of multi-modality aphasia therapy (M-MAT) preceded by 20 minutes of sham rTMS is achieved using a sham TMS coil which attenuates the magnetic output of the stimulator by 80%.', 'interventionNames': ['Behavioral: Multi-Modality Aphasia Therapy (M-MAT)', 'Device: 1Hz sham rTMS']}], 'interventions': [{'name': '1Hz inhibitory rTMS', 'type': 'DEVICE', 'description': '20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 coil', 'armGroupLabels': ['Multi-modality aphasia therapy plus 1Hz rTMS']}, {'name': 'Multi-Modality Aphasia Therapy (M-MAT)', 'type': 'BEHAVIORAL', 'description': 'Participants receive 3.5 hours of intensive speech therapy in small groups delivered by a blinded speech language pathologist and therapy assistant. The objective of M-MAT is to improve word production through shaping of responses (ie. Gradually increasing complexity of spoken targets towards eventual mastery) and social-mediated repetitive practice. Therapists use game-based interactive tasks and rich multi-modal cueing (gestures, written words, drawing, reading words) to improve spoken production and oral communication.', 'armGroupLabels': ['Multi-modality aphasia therapy plus 1Hz rTMS', 'Multi-modality aphasia therapy plus sham rTMS']}, {'name': '1Hz sham rTMS', 'type': 'DEVICE', 'description': '20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 sham coil.', 'armGroupLabels': ['Multi-modality aphasia therapy plus sham rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to make IPD available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr. Sean Dukelow', 'investigatorAffiliation': 'University of Calgary'}}}}