Nctid:
NCT06612437
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000020521", "term"=>"Stroke"}], "ancestors"=>[{"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M22306", "name"=>"Stroke", "asFound"=>"Stroke", "relevance"=>"HIGH"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-10", "completionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-10-01", "studyFirstSubmitDate"=>"2024-09-21", "studyFirstSubmitQcDate"=>"2024-09-21", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-02", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Sensorimotor event-related desynchronization", "timeFrame"=>"From enrollment to the end of treatment at 4 weeks, as well as one month post treatment", "description"=>"Electroencephalographical assessment for cortical activation induced by movement and mirror visual feedback-based observation of movement"}, {"measure"=>"Magnetic sensory evoked potential", "timeFrame"=>"Baseline, post one session, at the end of treatment, one month after treatmnet", "description"=>"Electroencephalographical assessment for cortical activation induced by periphral magenetic stimulation over the bilateral forearm."}], "primaryOutcomes"=>[{"measure"=>"Fugl-Meyer assessment of upper extremity (FMA-UE)", "timeFrame"=>"Baseline, at the end of treatment, one month after treatmnet", "description"=>"Fugl-Meyer Assessment of upper extremity (FMA-UE) scale is an index to assess the sensorimotor impairment in individuals who have had stroke. It contains motor assessment and sensory assessment. The motor parts includes 33 items assessing the movement, coordination and reflex actions of the shoulder, elbow, forearm and wrist, as well as the hand joints of the paretic arm. Each item consists of a three-point scale (0, 1 and 2), with a total maximum score of 66. The sensory component consists of 6 items assessing light touch and position of the shoulder, elbow, wrist, and thumb. Each item consists of a three-point scale (0, 1, and 2) with a total score of 12 points."}], "secondaryOutcomes"=>[{"measure"=>"Action Research Arm Test (ARAT)", "timeFrame"=>"Baseline, at the end of treatment, one month after treatmnet", "description"=>"The ARAT is a clinical assessment for upper limb functional activities for patients with stroke, which mainly focuses on the proximal and distal upper limb function. It consists of four subscales: grasp, grip, pinch and gross movement. It has 19 movement tasks, each graded using a four-point scale (total scores range from 0 to 57) (McDonnell, 2008). The MCID of ARAT is 5.70 points (Van der Lee et al., 2001)."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Stroke", "TMS", "TBS", "EEG"], "conditions"=>["Stroke", "Stroke Rehabilitation"]}, "referencesModule"=>{"references"=>[{"pmid"=>"35317611", "type"=>"RESULT", "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."}]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to identify the effect of different time intervals between continuous theta burst stimulation (cTBS) and intermittent theta burst stimulation(iTBS), on top of a standard robot-assisted training (RAT) for sensorimotor rehabilitation in patients with chronic stroke. Using electroencephalography (EEG) to explore potential sensorimotor neuroplasticity underying stroke.", "detailedDescription"=>"Delivering Intermittent theta burst stimulation (iTBS) primed with continuous theta burst stimulation (cTBS) to the primary motor cortex (M1) may enhance the facilitatory effect of iTBS on the stimulated M1 through metaplasticity. Previous studies have verified the effectiveness of priming iTBS on improving motor rehabilitation in patients with stroke. However, the optimal time interval between cTBS and iTBS remains unknown. The aim of this clinical trial is to identify the effect of different time intervals between cTBS and iTBS, followed with a standard robot-assisted training (RAT) for sensorimotor rehabilitation in patients with chronic stroke. Using electroencephalography (EEG) to explore potential sensorimotor neuroplasticity. A three-arm randomized controlled trial (RCT) will be performed with an estimated total of 30 patients with chronic stroke. All participants will be randomly allocated to receive 10-session intervention of different TBS protocols (i.e., cTBS-3min interval-iTBS, cTBS-10min interval-iTBS and cTBS-20min interval-iTBS), delivered for 2-4 sessions per week, lasting for 3-4 weeks. All participants will receive a 20-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 EEG."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. diagnosis of hemorrhagic or ischemic stroke using computed tomography (CT) or magnetic resonance imaging (MRI).\n2. the first-ever stroke with unilateral hemiplegia.\n3. 18-75 years old.\n4. chronic stroke ( ≥ 6 months).\n5. residual hemiparetic upper limb functional level 2-6 in the Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK).\n6. can understand and read Chinese.\n7. signed informed consent.\n\nExclusion Criteria:\n\n1. diagnosis of any clinically significant or unstable medical disorder.\n2. any contraindications to TMS based on the TMS safety guidelines (Rossi, Hallett, Rossini, \\& Pascual-Leone, 2011).\n3. inability to follow treatment instructions due to severe cognitive (using the Hong Kong version of the Montreal Cognitive Assessment (MoCA-HK) \\< 22/30) and communication deficiency.\n4. extreme spasticity over the hemiparetic upper limb (Modified Ashworth Score\\>2) or severe pain that hindered movement.\n5. a history of neurological or psychiatric disease excluding stroke, or current use of psychoactive medication (sedatives, antipsychotics, antidepressants, etc.)."}, "identificationModule"=>{"nctId"=>"NCT06612437", "acronym"=>"TMS", "briefTitle"=>"Optimization of Time Parameters of Priming iTBS for Poststroke Motor Rehabilitation", "organization"=>{"class"=>"OTHER", "fullName"=>"The Hong Kong Polytechnic University"}, "officialTitle"=>"Optimization of Time Parameters of Priming iTBS for Poststroke Motor Rehabilitation", "orgStudyIdInfo"=>{"id"=>"HSEARS20240229006"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Priming iTBS with 3-Minute Interval", "description"=>"short interval(3min) between cTBS and iTBS", "interventionNames"=>["Device: Theta burst stimulation (TBS)", "Behavioral: Robot-assisted training"]}, {"type"=>"EXPERIMENTAL", "label"=>"Priming iTBS with 10-Minute Interval", "description"=>"experimental interval(10min) between cTBS and iTBS", "interventionNames"=>["Device: Theta burst stimulation (TBS)", "Behavioral: Robot-assisted training"]}, {"type"=>"SHAM_COMPARATOR", "label"=>"Priming iTBS with 20-Minute Interval", "description"=>"long interval(20min) between cTBS and iTBS", "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"=>"Device: 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. The stimulation will be delivered with an intensity of 70% individual resting motor threshold .", "armGroupLabels"=>["Priming iTBS with 10-Minute Interval", "Priming iTBS with 20-Minute Interval", "Priming iTBS with 3-Minute Interval"]}, {"name"=>"Robot-assisted training", "type"=>"BEHAVIORAL", "otherNames"=>["rehabilitation robot"], "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.", "armGroupLabels"=>["Priming iTBS with 10-Minute Interval", "Priming iTBS with 20-Minute Interval", "Priming iTBS with 3-Minute Interval"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Hong Kong", "state"=>"HK", "country"=>"Hong Kong", "contacts"=>[{"name"=>"Kenneth, Nai Kuen FONG, PhD", "role"=>"CONTACT", "email"=>"kenneth.fong@polyu.edu.hk", "phone"=>"852 96507904"}, {"name"=>"Kenneth, Nai Kuen FONG, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"The Hong Kong Polytechnic University", "geoPoint"=>{"lat"=>22.27832, "lon"=>114.17469}}], "centralContacts"=>[{"name"=>"Kenneth, Nai Kuen FONG, PhD", "role"=>"CONTACT", "email"=>"kenneth.fong@polyu.edu.hk", "phone"=>"852 2766 6716"}, {"name"=>"YOUXIN SUI, Master", "role"=>"CONTACT", "email"=>"youxin.sui@connect.polyu.hk"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"To protect the privacy of patients"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"The Hong Kong Polytechnic University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Prof.", "investigatorFullName"=>"Kenneth N. K. Fong", "investigatorAffiliation"=>"The Hong Kong Polytechnic University"}}}}
