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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cTBS primed iTBS with 3-minute interval | Experimental | short interval(3min) between cTBS and iTBS |
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| cTBS primed iTBS with 10-minute interval | Experimental | experimental interval(10min) between cTBS and iTBS |
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| cTBS primed iTBS with 20-minute interval | Experimental | long interval(20min) between cTBS and iTBS |
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| Non-primed iTBS | Sham Comparator | iTBS alone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous theta burst stimulation (cTBS) | Device | Standard 600-pulse continuous theta burst stimulation (cTBS) can inhibit the corticomotor excitability. The cTBS will be delivered with an intensity of 70% individual resting motor threshold (RMT) of the hand knob over the contralesional M1. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer assessment of upper extremity (FMA-UE) | 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. | Baseline (Day 1, prior to first treatment), Day 21 (immediately after 10th treatment) , 1 month after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test (ARAT) | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Sensorimotor event-related desynchronization | Electroencephalographical assessment for cortical activation induced by movement and mirror visual feedback-based observation of movement | Baseline (Day 1, prior to first treatment), Day 1 (immediately after first treatment), Day 21 (immediately after 10th treatment) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Hong Kong | HK | Hong Kong | |||
| The Hong Kong Polytechnic University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35317611 | Result | 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. |
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To protect the privacy of patients
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| intermittent theta burst stimulation (iTBS) | Device | Standard 600-pulse intermittent theta burst stimulation (iTBS) can increase the corticomotor excitability. The iTBS will be delivered with an intensity of 70% individual resting motor threshold (RMT) of the hand knob over the contralesional M1. |
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| Robot-assisted training | Device | 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. |
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| Baseline (Day 1, prior to first treatment), Day 21 (immediately after 10th treatment) , 1 month after completion of treatment |
| Sensory evoked potential |
Electroencephalographical assessment for cortical activation induced by periphral magenetic stimulation over the bilateral forearm. |
| Baseline (Day 1, prior to first treatment), Day 1 (immediately after first treatment), Day 21 (immediately after 10th treatment) |
| Hong Kong |
| Hong Kong |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |