Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT03448133
Status:
WITHDRAWN
Last Update Posted:
2020-06-05
First Post:
2018-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
rTMS for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Because of the expiration of the previous ethical approval documents', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2018-02-10', 'studyFirstSubmitQcDate': '2018-02-21', 'lastUpdatePostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Boston naming test evaluation', 'timeFrame': 'Baseline', 'description': 'Assessment of the language production'}, {'measure': 'Boston naming test evaluation', 'timeFrame': 'One month(just after 20 times rTMS treatment)', 'description': 'Assessment of the language production'}, {'measure': 'Western Aphasia Battery(WAB) Speech fluency', 'timeFrame': 'Baseline', 'description': 'Assessment of the language production'}, {'measure': 'Western Aphasia Battery(WAB) Speech fluency', 'timeFrame': 'One month(just after 20 times rTMS treatment)', 'description': 'Assessment of the language production'}, {'measure': 'Repetition Part of WAB', 'timeFrame': 'Baseline', 'description': 'Assessment of the repetition ability'}, {'measure': 'Repetition Part of WAB', 'timeFrame': 'One month(just after 20 times rTMS treatment)', 'description': 'Assessment of the repetition ability'}, {'measure': 'Word recognition Part of WAB', 'timeFrame': 'Baseline', 'description': 'Assessment of the reading'}, {'measure': 'Word recognition Part of WAB', 'timeFrame': 'One month(just after 20 times rTMS treatment)', 'description': 'Assessment of the reading'}, {'measure': 'Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)', 'timeFrame': 'Baseline', 'description': 'Assessment of the grammar ability'}, {'measure': 'Syntax comprehension Part of Bilingual Aphasia Battery( Standard modern Chinese version)', 'timeFrame': 'One month(just after 20 times rTMS treatment)', 'description': 'Assessment of the grammar ability'}], 'secondaryOutcomes': [{'measure': 'fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)', 'timeFrame': 'Baseline', 'description': 'Graph theoretical analysis of the speech/language network'}, {'measure': 'fMRI parameters(strength, efficiency, clustering coefficient, and characteristic path length)', 'timeFrame': 'One month(just after 20 times rTMS treatment)', 'description': 'Graph theoretical analysis of the speech/language network'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aphasia, Primary Progressive', 'Repetitive Transcranical Magnetic Stimulation']}, 'descriptionModule': {'briefSummary': 'The primary progressive aphasia (PPA) is a neurodegenerative condition characterized by a gradual, irreversible decline of language function (Mesulam, 2001). There are no known treatments for PPA so far. The relentless progression of PPA symptoms eventually leads to a profound impairment in communication ability and, ultimately, to more generalized deficits of cognition. Some cases and small studies reported that Transcranial Magnetic Stimulation (TMS), one of the non-invasive neuromodulation tech, can be employed to facilitate language production and improve the language ability in patients with PPA. Herein we will explore the tolerance and efficacy of TMS for the treatment of PPA by the randomized controlled trial .Meanwhile the functional MRI tech will be used to investigate the neural network changing in the procedure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll participants had also been evaluated previously by a behavioral neurologist at the Peking Union Medical College Hospital and had been clinically diagnosed with a variant of PPA.\n\nExclusion Criteria:\n\n1. Scored below 15 on the mini-mental state exam (MMSE) due to concerns that global cognitive impairment might preclude their ability to follow the directions and interfere with task performance.\n2. Had a history of seizures or unexplained loss of consciousness, pregnancy, surgical breach of the skull, or any other medical or surgical contraindication to receiving noninvasive brain stimulation.\n3. Is unable to complete the treatment and evaluations'}, 'identificationModule': {'nctId': 'NCT03448133', 'briefTitle': 'rTMS for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Repetitive Transcranial Magnetic Stimulation for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Tria', 'orgStudyIdInfo': {'id': 'rTMSPPA-PUMCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rTMS treatment group', 'description': 'The participants will be devided into rTMS treatment and sham treatment by means of randomized methods.The protocol of treatment is to use rTMS with high frequency 10/20Hz 120%RMT 20 times for one month. The device is Magtism rTMS made in London, UK', 'interventionNames': ['Device: Magstim rTMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham treatment group', 'description': 'The control group is to receive sham treatment. The device is the same as the one used in the real treatment group.', 'interventionNames': ['Device: Magstim rTMS']}], 'interventions': [{'name': 'Magstim rTMS', 'type': 'DEVICE', 'description': 'The device is made in London,UK', 'armGroupLabels': ['rTMS treatment group', 'sham treatment group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}