Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT06147167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2023-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Individualized iTBS on Upper Limb Function After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010291', 'term': 'Paresis'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D009788', 'term': 'Occupational Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 159}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2023-11-19', 'studyFirstSubmitQcDate': '2023-11-19', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment-upper extremity', 'timeFrame': 'Befor and after the treatment, and 1 month after the treatment.', 'description': 'Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had stroke. The FMA motor assessments for the upper fucntion with maximum score 66 points, including relflex activity, flexor synergy, extensor synergy, movement combining synergies, movement out of synergy,normal reflex, wrist function, hand function and coordination/speed, and sensory assessment.'}], 'secondaryOutcomes': [{'measure': 'modified Rankin Scale', 'timeFrame': 'Befor and after the treatment, and 1 month after the treatment.', 'description': 'The Modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death.'}, {'measure': 'Action Research Arm Test', 'timeFrame': 'Befor and after the treatment, and 1 month after the treatment.', 'description': 'The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations.Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).'}, {'measure': 'handrip test', 'timeFrame': 'Befor and after the treatment, and 1 month after the treatment.', 'description': 'Hand grip test will be finished with a dynamometer.'}, {'measure': 'functional nearinfrared spectroscopy', 'timeFrame': 'Befor and after the treatment, and 1 month after the treatment.', 'description': 'The functional nearinfrared spectroscopy (fNIRS) is used to explore the motor network of the participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intermittent theta burst stimulation;', 'upper extremity paresis;', 'functional nearinfrared spectroscopy'], 'conditions': ['Upper Extremity Paresis', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '35931377', 'type': 'BACKGROUND', 'citation': 'Kong G, Wei L, Wang J, Zhu C, Tang Y. The therapeutic potential of personalized connectivity-guided transcranial magnetic stimulation target over group-average target for depression. Brain Stimul. 2022 Sep-Oct;15(5):1063-1064. doi: 10.1016/j.brs.2022.07.054. Epub 2022 Aug 2. No abstract available.'}, {'pmid': '34800726', 'type': 'BACKGROUND', 'citation': 'Klooster DCW, Ferguson MA, Boon PAJM, Baeken C. Personalizing Repetitive Transcranial Magnetic Stimulation Parameters for Depression Treatment Using Multimodal Neuroimaging. Biol Psychiatry Cogn Neurosci Neuroimaging. 2022 Jun;7(6):536-545. doi: 10.1016/j.bpsc.2021.11.004. Epub 2021 Nov 17.'}, {'pmid': '33653120', 'type': 'BACKGROUND', 'citation': 'Ferrarelli F, Phillips ML. Examining and Modulating Neural Circuits in Psychiatric Disorders With Transcranial Magnetic Stimulation and Electroencephalography: Present Practices and Future Developments. Am J Psychiatry. 2021 May 1;178(5):400-413. doi: 10.1176/appi.ajp.2020.20071050. Epub 2021 Mar 3.'}, {'pmid': '30945588', 'type': 'BACKGROUND', 'citation': 'Siddiqi SH, Trapp NT, Shahim P, Hacker CD, Laumann TO, Kandala S, Carter AR, Brody DL. Individualized Connectome-Targeted Transcranial Magnetic Stimulation for Neuropsychiatric Sequelae of Repetitive Traumatic Brain Injury in a Retired NFL Player. J Neuropsychiatry Clin Neurosci. 2019 Summer;31(3):254-263. doi: 10.1176/appi.neuropsych.18100230. Epub 2019 Apr 3.'}, {'pmid': '32299324', 'type': 'BACKGROUND', 'citation': 'Cassidy JM, Wodeyar A, Wu J, Kaur K, Masuda AK, Srinivasan R, Cramer SC. Low-Frequency Oscillations Are a Biomarker of Injury and Recovery After Stroke. Stroke. 2020 May;51(5):1442-1450. doi: 10.1161/STROKEAHA.120.028932. Epub 2020 Apr 17.'}, {'pmid': '31332903', 'type': 'BACKGROUND', 'citation': 'Cash RFH, Cocchi L, Anderson R, Rogachov A, Kucyi A, Barnett AJ, Zalesky A, Fitzgerald PB. A multivariate neuroimaging biomarker of individual outcome to transcranial magnetic stimulation in depression. Hum Brain Mapp. 2019 Nov 1;40(16):4618-4629. doi: 10.1002/hbm.24725. Epub 2019 Jul 22.'}, {'pmid': '35582784', 'type': 'BACKGROUND', 'citation': 'Ge R, Humaira A, Gregory E, Alamian G, MacMillan EL, Barlow L, Todd R, Nestor S, Frangou S, Vila-Rodriguez F. Predictive Value of Acute Neuroplastic Response to rTMS in Treatment Outcome in Depression: A Concurrent TMS-fMRI Trial. Am J Psychiatry. 2022 Jul;179(7):500-508. doi: 10.1176/appi.ajp.21050541. Epub 2022 May 18.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this clinical study is to assess the comparative efficacy of individualized intermittent theta burst stimulation (iTBS) in contrast to standard iTBS for individuals post-stroke experiencing upper limb impairment. The key inquiries addressed in this study encompass:\n\nEnhancement of Upper Limb Function: The primary investigation seeks to determine whether individualized iTBS yields superior improvements in upper limb functionality compared to standard iTBS.\n\nLong-Term Effects: This study endeavors to explore the sustained effects of both individualized and standard iTBS on upper limb function over an extended duration.\n\nNeural Mechanisms Investigation: Functional near-infrared spectroscopy (fNIRS) will be employed to elucidate the neural mechanisms underlying the impact of iTBS on the enhancement of upper limb function.\n\nPost-stroke individuals with upper limb impairment will undergo pre-treatment assessments, including motor function evaluations and fNIRS tests. Subsequently, they will be randomized into three groups: individualized iTBS, standard iTBS, and sham stimulation. Participants will undergo post-treatment assessments and follow-up evaluations.\n\nThe research team aims to discern disparities in the efficacy of different iTBS modalities. The central hypothesis posits that individualized iTBS will demonstrate superior efficacy in enhancing post-stroke upper limb function, with sustained effects persisting for a minimum of one month.', 'detailedDescription': "This research constitutes a single-center, double-blind, randomized controlled study. Upon enrollment, baseline information is established through the assessment of upper limb function using the Fugl Meyer Assessment (FMA), the modified Rankin Scale, the Action Research Arm Test (ARAT), and a handgrip test. Additionally, functional near-infrared spectroscopy (fNIRS) is employed to assess brain function, providing insights into the patient's motor network.\n\nParticipants in the study are randomly assigned to one of three groups: individualized iTBS, standard iTBS, and sham stimulation. All participants undergo physical therapy and occupational therapy tailored to their functional evaluation. After three weeks of treatment, participants are required to complete the aforementioned assessments, with a follow-up evaluation scheduled one month post-treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aging from 18-80\n2. diagnosed as first-happened stroke,duration of the disease ranged from 1-3 months\n3. upper extremity impairment\n4. with mini-mental state examination\\>15\n5. agree to participate in this study and sigh the informed consent\n\nExclusion Criteria:\n\n1. with stroke history\n2. have metal device within the body\n3. with history of upper extremity trauma,fracture, and/or burn\n4. serious conditions and can not finish the examination and treatment'}, 'identificationModule': {'nctId': 'NCT06147167', 'briefTitle': 'Effects of Individualized iTBS on Upper Limb Function After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Effects of Individualized iTBS on Upper Limb Function After Stroke', 'orgStudyIdInfo': {'id': 'KYLL-202307-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'indvidualized iTBS', 'description': 'In this arm of the study, participants undergo individualized intermittent theta burst stimulation (iTBS) subsequent to encephalography (EEG) testing. Three electrodes are strategically positioned on the first dorsal interosseous (FDI) hotspot to record the resting theta frequency, which is subsequently utilized as the theta frequency for theta burst stimulation (TBS). The participants receive this treatment regimen once daily, five times a week, over a total duration of three weeks.', 'interventionNames': ['Device: individualized intermittent theta burst sitmulation (iTBS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard iTBS', 'description': 'In this particular arm of the study, participants also undergo an initial electroencephalography (EEG) procedure. Subsequently, intermittent theta burst stimulation (iTBS) is administered using the standard theta burst stimulation frequency of 5Hz. The participants receive this treatment once daily, five times a week, over a total duration of three weeks.', 'interventionNames': ['Device: standard iTBS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham iTBS', 'description': 'In this arm, the treatment procedure is similar to the standard iTBS unless the coil is perpendicular to the scalp.', 'interventionNames': ['Device: sham stimulation']}], 'interventions': [{'name': 'individualized intermittent theta burst sitmulation (iTBS)', 'type': 'DEVICE', 'otherNames': ['physical therapy', 'occupational therapy'], 'description': 'Participants undergo daily sessions of individualized intermittent theta-burst stimulation (iTBS) administered with the MagStim stimulator (Rapid2, MagStim, Whiteland, United States). The intervention spans five days a week and extends over a three-week period. In this group, participants receive a personalized iTBS protocol comprising three pulses of stimulation delivered at 50 Hz, repeated every 200 ms. The stimulation frequency is tailored based on the electroencephalogram (EEG) results and is administered every 10 seconds, with a total duration of 190 seconds. The treatment is administered once a day for five days a week and continues for three weeks, with an immediate cessation in case of any discomfort. This study design ensures a meticulous and tailored approach to iTBS administration.', 'armGroupLabels': ['indvidualized iTBS']}, {'name': 'standard iTBS', 'type': 'DEVICE', 'otherNames': ['physical therapy', 'occupational therapy'], 'description': 'The MagStim stimulator (Rapid2, MagStim, Whiteland, United States) was employed in the current study. The intermittent theta-burst stimulation (iTBS) protocol utilized three pulses of stimulation delivered at a frequency of 50 Hz, with a repetition rate of every 200 ms. These pulses were organized into 2-second trains, repeated every 10 seconds, resulting in a cumulative duration of 190 seconds (equivalent to a total of 600 pulses). Notably, the administration of the treatment ceased promptly in the event of any participant discomfort.', 'armGroupLabels': ['standard iTBS']}, {'name': 'sham stimulation', 'type': 'DEVICE', 'otherNames': ['physical therapy', 'occupational therapy'], 'description': 'The device and protocol are identical to the standard iTBS, with the only difference being the orientation of the coil, which is perpendicular to the scalp.', 'armGroupLabels': ['sham iTBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yonghui Wang, professor', 'role': 'CONTACT', 'email': 'yonghuiw6606@126.com', 'phone': '86-18560083581'}], 'overallOfficials': [{'name': 'Yonghui Wang, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}