An interventional study of Intermittent theta burst stimulation and Mirror Therapy in Stroke and Hemiplegia, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
The study aims to test the hypothesis that rTMS in the form of theta burst stimulation (TBS) over the ipsilateral and contralateral motor cortices can modulate mirror illusion-induced rhythm suppression while observing unilateral arm movement in stroke individuals. The investigators further hypothesize that this intervention will lead to the revision of interhemispheric asymmetry. Finally, this study will also explore the longitudinal relationship between rhythm suppression and motor recovery as indicated by motor excitability in the form of MEP. The results of this study will provide significant new information regarding neurophysiological motor relearning mechanisms which could inform the development and evaluation of innovative treatments for individuals with stroke
Stroke is the leading cause of physical disability. Facilitating the process of motor relearning would greatly accelerate the rehabilitation of motor functions and elicit positive neuroplasticity of the damaged brain area. Previous research has already explored the feasibility of motor priming techniques embedded in stroke rehabilitation programs using strategies such as non-invasive brain stimulation (NIBS) and mirror therapy (MT). These treatments are usually implemented along with the standardized rehabilitation, sequentially or simultaneously, and have been demonstrated to be more effective than the standardized rehabilitation programs alone.
Mirror neuron, as indicated traditionally by the decrease in the amplitude of Mu rhythm, i.e. a suppression over central electrodes of electroencephalography (EEG), reflects the "seeing" of movement after "perception". Such oscillations are based on neural substrates that are discharged during the observation and execution of a motor act, which is also associated with other human functions, such as imitation, language, etc. The core mirror neuron system (MNS) is thought to be located in the premotor and the primary sensorimotor cortices, indicating that motor learning could be enhanced during action observation and overt movement.
Preliminary research has shown that repetitive Transcranial Magnetic Stimulation (rTMS) can enhance the corticomotor excitability in mirror neurons during both observation of movement (by others) or imagined movement in healthy subjects; in particular, as measured by enhanced motor evoked potentials (MEP). Increases in MEP has also been induced by short-term action observation and mirror visual feedback in stroke survivors. However, it is not yet known if MNS can be activated by TMS in MT following a stroke, and the relationship between mirror neuron activation and clinical improvements in stroke remains unclear.
The investigators have already published preliminary findings in patients with hemiplegic upper extremity, rTMS, and MT. Here, the investigators propose to test the hypothesis that rTMS in the form of theta-burst stimulation (TBS) over the ipsilateral and contralateral motor cortices can modulate mirror illusion-induced rhythm suppression while observing unilateral arm movement in stroke individuals. The investigators further hypothesize that this intervention will lead to the revision of interhemispheric asymmetry. Finally, this study will also explore the longitudinal relationship between rhythm suppression and motor recovery as indicated by motor excitability in the form of MEP. The results of this study will provide significant new information regarding neurophysiological motor relearning mechanisms which could inform the development and evaluation of innovative treatments for individuals with stroke
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iTBS: iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients. After the iTBS therapy, participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to synchronize with the non-affected hand (illusion on the mirror). The movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.
Device: Intermittent theta burst stimulation · Behavioral: Mirror Therapy
iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere, but with a sham coil (i.e., sham iTBS). After the sham stimulation, participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to synchronize with the non-affected hand (illusion on the mirror). The movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.
Behavioral: Mirror Therapy · Device: Sham intermittent theta burst stimulation
iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients. After the iTBS therapy, participants will practice the movements with the non-affected hand and try moving the affected arm at the same time, but with a covered mirror (e.g., sham mirror therapy). In the sham mirror therapy condition, the mirror is covered by a cloth and the participant is instructed to move both arms while looking at a cross mark on the covered mirror and imaging the analogous movements of the affected arm. The movement practice will involve 5 table-top tasks (same as mirror therapy) and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.
Device: Intermittent theta burst stimulation · Behavioral: Sham mirror Therapy
iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients, by using a butterfly shape coil.
Participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to synchronize with the non-affected hand (illusion on the mirror). The movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.
iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients. However, a sham coil will be used, which is not associated with any stimulation effect on the brain.
In sham mirror therapy, the mirror will be covered. Participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to move the non-affected hand. The participants cannot receive mirror visual feedback of the paretic upper extremity movement during the therapy. Same as mirror therapy, the movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.
Fugl-Meyer assessment (FMA)
A stroke-specific, performance-based impairment index
Time frame: Baseline
Fugl-Meyer assessment (FMA)
A stroke-specific, performance-based impairment index
Time frame: 1 day
Fugl-Meyer assessment (FMA)
A stroke-specific, performance-based impairment index
Time frame: 2 weeks
Fugl-Meyer assessment (FMA)
A stroke-specific, performance-based impairment index
Time frame: 1-month after the completion of the intervention
Action Research Arm Test (ARAT)
A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Time frame: Baseline (immediately before the first session)
Action Research Arm Test (ARAT)
A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Time frame: 1 day
Action Research Arm Test (ARAT)
A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Time frame: 2 weeks
Action Research Arm Test (ARAT)
A measure of upper extremity performance (coordination, dexterity and functioning) in stroke recovery
Time frame: 1-month after the completion of the intervention
EEG rhythm power
Rhythm power desynchronization/synchronization in response to mirror visual feedback
Time frame: Baseline (immediately before the first session)
EEG rhythm power
Rhythm power desynchronization/synchronization in response to mirror visual feedback
Time frame: 1 day
EEG rhythm power
Rhythm power desynchronization/synchronization in response to mirror visual feedback
Time frame: 2 weeks
EEG rhythm power
Rhythm power desynchronization/synchronization in response to mirror visual feedback
Time frame: 1-month after the completion of the intervention
Motor-evoked Potential (MEP)
Electrical potential recorded over a hand muscle, evoked by stimulating the primary motor cortex.
Time frame: Baseline (immediately before the first session)
Motor-evoked Potential (MEP)
Electrical potential recorded over a hand muscle, evoked by stimulating the primary motor cortex.
Time frame: 1 day
Motor-evoked Potential (MEP)
Electrical potential recorded over a hand muscle, evoked by stimulating the primary motor cortex.
Time frame: 2 weeks
Motor-evoked Potential (MEP)
Electrical potential recorded over a hand muscle, evoked by stimulating the primary motor cortex
Time frame: 1-month after the completion of the intervention
Cortical silent period
The cortical silent period (cSP) refers to an interruption of voluntary muscle activities during contraction by stimulating the contralateral primary motor cortex.
Time frame: Baseline (immediately before the first session)
Cortical silent period
The cortical silent period (cSP) refers to an interruption of voluntary muscle activities during contraction by stimulating the contralateral primary motor cortex.
Time frame: 1 day
Cortical silent period
The cortical silent period (cSP) refers to an interruption of voluntary muscle activities during contraction by stimulating the contralateral primary motor cortex.
Time frame: 2 weeks
Cortical silent period
The cortical silent period (cSP) refers to an interruption of voluntary muscle activities during contraction by stimulating the contralateral primary motor cortex.
Time frame: 1-month after the completion of the intervention
Ipsilateral silent period
Ipsilateral silent period (iSP) is an interruption of ongoing muscle activities caused by stimulating ipsilateral primary motor cortex.
Time frame: Baseline (immediately before the first session)
Ipsilateral silent period
Ipsilateral silent period (iSP) is an interruption of ongoing muscle activities caused by stimulating ipsilateral primary motor cortex.
Time frame: 1 day
Ipsilateral silent period
Ipsilateral silent period (iSP) is an interruption of ongoing muscle activities caused by stimulating ipsilateral primary motor cortex.
Time frame: 2 weeks
Ipsilateral silent period
Ipsilateral silent period (iSP) is an interruption of ongoing muscle activities caused by stimulating ipsilateral primary motor cortex.
Time frame: 1-month after the completion of the intervention
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