Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-04 @ 1:44 AM
Study NCT ID:
NCT04034069
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2019-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2019-07-23', 'studyFirstSubmitQcDate': '2019-07-24', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE)', 'timeFrame': 'Baseline', 'description': 'FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.'}, {'measure': 'Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE)', 'timeFrame': '1 week', 'description': 'FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.'}, {'measure': 'Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE)', 'timeFrame': '2 weeks', 'description': 'FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.'}, {'measure': 'Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE)', 'timeFrame': '2 weeks after the completion of training', 'description': 'FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.'}, {'measure': 'Action Research Arm Test (ARAT)', 'timeFrame': 'Baseline', 'description': "ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement."}, {'measure': 'Action Research Arm Test (ARAT)', 'timeFrame': '1 week', 'description': "ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement."}, {'measure': 'Action Research Arm Test (ARAT)', 'timeFrame': '2 week', 'description': "ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement."}, {'measure': 'Action Research Arm Test (ARAT)', 'timeFrame': '2 weeks after the completion of training', 'description': "ARAT is a standard upper limb functional performance assessment for stroke survivors. ARAT assesses a patient's ability to handle objects differing in size, weight and shape. ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement."}], 'secondaryOutcomes': [{'measure': 'Sensorimotor event-related desynchronization', 'timeFrame': 'Baseline', 'description': 'Electroencephalographical assessment for cortical activation induced by movement and mirror visual feedback-based observation of movement'}, {'measure': 'Sensorimotor event-related desynchronization', 'timeFrame': '2 weeks', 'description': 'Electroencephalographical assessment for cortical activation induced by movement and mirror visual feedback-based observation of movement'}, {'measure': 'Mean velocity', 'timeFrame': 'Baseline', 'description': 'Mean velocity is a quantified assessment for movement efficiency during robot-assisted training with Fourier M2 device.'}, {'measure': 'Mean velocity', 'timeFrame': '2 weeks', 'description': 'Mean velocity is a quantified assessment for movement efficiency during robot-assisted training with Fourier M2 device.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'theta burst stimulation', 'upper limb', 'metaplasticity', 'priming'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '35317611', 'type': 'DERIVED', 'citation': 'Zhang JJ, Bai Z, Fong KNK. Priming Intermittent Theta Burst Stimulation for Hemiparetic Upper Limb After Stroke: A Randomized Controlled Trial. Stroke. 2022 Jul;53(7):2171-2181. doi: 10.1161/STROKEAHA.121.037870. Epub 2022 Mar 23.'}, {'pmid': '32152174', 'type': 'DERIVED', 'citation': 'Zhang JJ, Fong KNK. Effects of priming intermittent theta burst stimulation on upper limb motor recovery after stroke: study protocol for a proof-of-concept randomised controlled trial. BMJ Open. 2020 Mar 8;10(3):e035348. doi: 10.1136/bmjopen-2019-035348.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of intermittent theta burst stimulation primed with continous theta burst stimulation (cTBS), on top of a standard robot-assisted training (RAT) on improving the upper limb motor functions of stroke survivors and to explore potential sensorimotor neuroplasticity with electroencephalography (EEG).', 'detailedDescription': 'Intermittent theta burst stimulation (iTBS) delivered to the affected primary motor cortex (M1) appears to enhance the brain response to rehabilitative intervention in patients with stroke. However, its clinical utility is highly affected by the response variability. New evidence has reported that preceding iTBS with a priming session of continuous theta burst stimulation (cTBS), may stabilize and even boost the facilitatory effect of iTBS on the stimulated M1, via metaplasticity. The aim of this study is to investigate the effects of iTBS primed with cTBS, on top of a standard robot-assisted training (RAT) on improving the upper limb motor functions of patients with chronic stroke and to explore potential sensorimotor neuroplasticity with electroencephalography (EEG). A three-arm randomized controlled trial (RCT) will be performed with an estimated total of 36 patients with subacute or chronic stroke. All participants will be randomly allocated to receive 10-session intervention of different TBS protocols (i.e., cTBS+iTBS, sham cTBS+iTBS and sham cTBS+sham iTBS), delivered for 3-5 sessions per week, lasting for 2-3 weeks. All participants will receive a 60-minute standard RAT after each stimulation session. Primary outcome will be Fugl-Meyer Assessment-Upper Extremity scores (FMA-UE). Secondary outcomes will be Action Research Arm Test (ARAT), kinematic outcomes generated during RAT as well as and EEG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* with a diagnosis of a unilateral ischemic or hemorrhagic stroke;\n* with stroke onset more than 6 months;\n* from 18 to 75 years old;\n* with mild to moderate impairment of upper limb functions due to stroke, measured using the Hong Kong Version of the Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK) from level 2 to level 7;\n* be able to understand verbal instruction and follow one-step commands;\n* be able to give informed consent to participate;\n\nExclusion Criteria:\n\n* any contraindications to rTMS/TBS, such as unstable medical condition, history of epileptic seizures, metal implants in vivo (eg, pacemaker, artificial cochlear, and implant brain stimulator), and a history of receiving craniotomy;\n* previous diagnosis of any neurological disease excluding stroke;\n* presence of any sign of cognitive problems (Abbreviated mental test Hong Kong version \\< 6/10);\n* patients with extreme spasticity in any hemiplegic upper limb joint (Modified Ashworth score \\> 2) or severe pain that hinder the upper limb motor training;\n* with other notable impairment of the upper limb affected by stroke, eg, recent fracture, severe osteoarthritis, congenital upper limb deformity\n* any sign of anxiety or depression, as assessed by the Hospital Anxiety and Depression Scale.\n* concurrent participation in an upper limb rehabilitation program or a medicine trial.'}, 'identificationModule': {'nctId': 'NCT04034069', 'briefTitle': 'Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HSEARS20190718003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cTBS + iTBS, in addition to robot-assisted training', 'description': 'Participants will receive 10-session intervention of priming iTBS protocol (cTBS followed by iTBS, with an interval of 10 minutes). The stimulation will be delivered 3-5 sessions per week, lasting for 2-3 weeks. Participants will receive a 60-minute standard robot-assisted training after each stimulation session.', 'interventionNames': ['Device: Theta burst stimulation (TBS)', 'Behavioral: Robot-assisted training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sham cTBS + iTBS, in addition to robot-assisted training', 'description': 'Participants will receive 10-session intervention of non-primed, standard iTBS (sham cTBS followed by iTBS, with an interval of 10 minutes). The stimulation will be delivered 3-5 sessions per week, lasting for 2-3 weeks. Participants will receive a 60-minute standard robot-assisted training after each stimulation session.', 'interventionNames': ['Device: Theta burst stimulation (TBS)', 'Behavioral: Robot-assisted training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham cTBS + sham iTBS, in addition to robot-assisted training', 'description': 'Participants will receive 10-session intervention of sham stimulation (sham cTBS followed by sham iTBS, with an interval of 10 minutes). The stimulation will be delivered 3-5 sessions per week, lasting for 2-3 weeks. Participants will receive a 60-minute standard robot-assisted training after each stimulation session.', 'interventionNames': ['Device: Theta burst stimulation (TBS)', 'Behavioral: Robot-assisted training']}], 'interventions': [{'name': 'Theta burst stimulation (TBS)', 'type': 'DEVICE', 'otherNames': ['Repetitive transcranial magnetic stimulation (rTMS)'], 'description': 'Theta burst stimulation (TBS) is a potent form of repetitive transcranial magnetic stimulation (rTMS). Standard 600-pulse intermittent theta burst stimulation (iTBS) can enhance the corticomotor excitability, whereas standard 600-pulse continuous theta burst stimulation (cTBS) can suppress the corticomotor excitability. Sham stimulation uses an extreme low stimulation intensity which will not influence with corticomotor excitability. In the present study, real stimulation will be delivered in an intensity of 70% individual resting motor threshold while sham stimulation will be delivered in an intensity of 20% individual resting motor threshold.', 'armGroupLabels': ['Sham cTBS + iTBS, in addition to robot-assisted training', 'Sham cTBS + sham iTBS, in addition to robot-assisted training', 'cTBS + iTBS, in addition to robot-assisted training']}, {'name': 'Robot-assisted training', 'type': 'BEHAVIORAL', 'description': 'Fourier M2 upper limb rehabilitation robot (Fourier Intelligence Co. Ltd., Shanghai, China), will be used for upper limb proximal joints training. Fourier M2 upper limb rehab robot is an end-effector robot-assisted device. The device targets (1) flexion and extension of shoulder joint, (2) flexion and extension of elbow, (3) internal and external rotation of shoulder joint, and (4) abduction and adduction of shoulder joint, supported by tailored interactive TV games in the device. HandyRehab hand robot (Zunosaki Company Ltd., Hong Kong SAR) will be used for upper limb distal joints training. It is an exoskeleton over the hand which provides power-driven extension and grasping force to the fingers and thumb in order to assist the patient to open and close the paretic hand by means of surface electromyography-triggered from the signals through the forearm extensors and flexors.', 'armGroupLabels': ['Sham cTBS + iTBS, in addition to robot-assisted training', 'Sham cTBS + sham iTBS, in addition to robot-assisted training', 'cTBS + iTBS, in addition to robot-assisted training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Hong Kong Polytechnic University, Department of Rehabilitation Sciences', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will be shared for research purpose upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kenneth N. K. Fong', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}