Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-01-07 @ 6:35 PM
Study NCT ID:
NCT06849505
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2025-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Magnetic Stimulation Synchronized with Motor Task Training for Post-Stroke Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], '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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment - Upper Extremity (FMA-UE)', 'timeFrame': 'Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 60 after 2-week intervention', 'description': 'The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.\n\nThe Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is the upper limb motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand. It ranges from 0 (hemiplegia) to 66 points (normal motor performance).'}], 'secondaryOutcomes': [{'measure': 'Modified Barthel Index (MBI)', 'timeFrame': 'Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 60 after 2-week intervention', 'description': 'The Barthel Index for activities of daily living was introduced in 1965 by Barthel and Mahoney to be used in the assessment of the degree of assistance required by patients with stroke (other neuromuscular or musculoskeletal disorders or oncology patients) with regards to 10 items of mobility and self-care (ADL).'}, {'measure': 'The Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 60 after 2-week intervention', 'description': "The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval.\n\nThe PSQI is commonly used in both clinical and research settings to evaluate various aspects of sleep. It is a valuable tool for assessing sleep quality as it captures multiple dimensions of sleep, including both subjective experiences and objective parameters. It allows researchers and healthcare providers alike to obtain a comprehensive understanding of an individual's sleep patterns and disturbances and inform treatment decisions and interventions for sleep disorders."}, {'measure': 'Motor Evoked Potential (MEP) - Resting Motor Threshold (RMT)', 'timeFrame': 'Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 60 after 2-week intervention', 'description': 'Resting motor threshold is an objective measure of cortical excitability. Numerous studies indicate that the success of motor recovery after stroke is significantly determined by the direction and extent of cortical excitability changes.'}, {'measure': 'The average completion time for baseline tasks', 'timeFrame': 'Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day7, Day 8, Day 9, Day 10 during TMS intervention', 'description': 'The average completion time for baseline tasks refers to the time (seconds) taken by the patient to complete the baseline motor task before each intervention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'individualized', 'TMS', 'motor dysfunction', 'online'], 'conditions': ['Stroke', 'Upper Extremity Parasis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trials is to investigate the effectiveness of individualized online repetitive transcranial magnetic stimulation (rTMS) in enhancing upper limb motor rehabilitation during the subacute and chronic phase of stroke. It will also learn about the safety of individualized online rTMS intervention methods. The main questions it aims to answer are:\n\nDoes rTMS synchronized with motor training improve motor rehabilitation in patients with the ability to induce motor evoked potentials(MEPs)？ Dose individualized rTMS synchronized with motor training improve motor rehabilitation in patients without the ability to induce MEPs? Researchers will compare online rTMS to offline and sham stimulation in patients with MEPs to see if online rTMS works to alleviate motor dysfunction in preliminary trials. And compare individualized online rTMS to non-individualized online rTMS and sham in patients without MEPs to see if individualized online rTMS works to alleviate motor dysfunction in Randomized, double-blinded, and controlled trials.\n\nParticipants will:\n\nrandomized to one group acoording to the MEP condition of each person; receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks; receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment; conduct scales and MEP assessment one day before the treatment, as well as one day, one month, and three months after the treatment.', 'detailedDescription': 'In our experiment, patients were be randomly assigned to three groups: online, offline and sham groups. if patients were able to induce MEPs, intensity of TMS will be 80% RMT; if not , inensity of TMS will be 70% of TMS output.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient is first diagnosed with stroke through neurological examination, CT or MRI scan.\n2. The vital signs are stable and there is a certain degree of upper limb motor dysfunction.\n3. The age is between 20 and 80 years old.\n4. The cognitive ability is not significantly affected and the patient can cooperate with various examinations and assessments, with a MMSE score ≥ 20 points.\n5. There are no serious complications (such as pneumonia, heart failure, urinary tract infection or malnutrition).\n6. There is no pathological condition that is a contraindication for TMS in the medical history (for example, patients with metal in the brain, such as aneurysm clips, patients with a cardiac pacemaker, pregnant women, or those with a history of epileptic seizures).\n7. The patient or guardian agrees to sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with severe heart, lung, liver, kidney diseases and malignant tumors;\n2. Those with a history of aphasia, severe cognitive impairment or mental illness;\n3. Patients who have had a history of epileptic seizures in the last month or are taking anti-epileptic drugs recently;\n4. Those with severe visual or hearing impairments, unable to communicate normally;\n5. People with metal implants, pacemakers, skull defects or other conditions that prevent them from undergoing TMS.'}, 'identificationModule': {'nctId': 'NCT06849505', 'acronym': 'TMS', 'briefTitle': 'Transcranial Magnetic Stimulation Synchronized with Motor Task Training for Post-Stroke Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University"}, 'officialTitle': 'Closed - Loop Neuromodulation of Post - Stroke Motor Dysfunction by Transcranial Magnetic Stimulation Synchronized with Specific Motor Task Training', 'orgStudyIdInfo': {'id': 'CHEC2025-055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'online rTMS', 'description': 'In the online stimulation group, the TMS treatment will continuously adjust the TMS parameters according to the baseline data and the data changes during the treatment to achieve personalized intervention. When patients receive TMS treatment, it is combined with upper limb movement tasks. When the task starts autonomously, TMS stimulation is triggered through electromyographic feedback. When the task stops or is completed, the TMS stimulation also stops immediately according to the electromyographic feedback, achieving real - time effects.', 'interventionNames': ['Device: online rTMS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'offline rTMS', 'description': 'For the offline stimulation group, TMS treatment will be carried out before the task starts. After the stimulation ends, the subjects will then complete the task.', 'interventionNames': ['Device: offline rTMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham rTMS', 'description': 'Patients in the sham group also receive sham stimulation treatment combined with specific tasks, which is the same as the online stimulation group, except that the TMS stimulation is sham stimulation.', 'interventionNames': ['Device: sham rTMS']}], 'interventions': [{'name': 'online rTMS', 'type': 'DEVICE', 'description': '5 Hz rTMS is applied to the MRI-localized hotspot on the affected hemisphere when the patients are performing motor tasks', 'armGroupLabels': ['online rTMS']}, {'name': 'offline rTMS', 'type': 'DEVICE', 'description': 'The patients perform motor tasks after 5 Hz rTMS applied to the MRI-guided hotspot on the affected hemisphere', 'armGroupLabels': ['offline rTMS']}, {'name': 'sham rTMS', 'type': 'DEVICE', 'description': 'Sham rTMS is applied to the M1 on the affected hemisphere when the patients are performing motor tasks.', 'armGroupLabels': ['sham rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200021', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jia Min Li', 'role': 'CONTACT', 'email': 'Lijm0814@163.com', 'phone': '+86-13917245215'}], 'facility': "First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ying Wang', 'role': 'CONTACT', 'email': '1327907674@qq.com', 'phone': '+86-15221359901'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'The investigators will share the demographic information and baseline clinical data of all participants.', 'accessCriteria': "Authorized professional researchers, including but not limited to researchers engaged in neuroscience research who have obtained data access permission from their affiliated institutions, and clinical doctors from other medical institutions that have a cooperative relationship with this study and have signed data confidentiality agreements.\n\nThey can access the detailed clinical medical histories of the participants, including past disease histories and treatment process records; neurological function assessment scale data; as well as imaging data collected during the study, such as brain magnetic resonance imaging (MRI) results. However, sensitive information related to participants' privacy, such as names, ID numbers, and contact information, will be strictly anonymized to ensure that such information cannot be obtained.\n\nThey can contact the corresponding author or the first author via email."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University", 'class': 'OTHER'}, 'collaborators': [{'name': 'shanghai center for brain science and brain-inspired technology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xiaonan Huang', 'investigatorAffiliation': "First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University"}}}}