scholarly journals 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 ◽  
Vol 10 (3) ◽  
pp. e035348
Author(s):  
Jack Jiaqi Zhang ◽  
Kenneth N K Fong
Keyword(s):  
Randomised Controlled Trial ◽  
Upper Limb ◽  
Primary Motor Cortex ◽  
Controlled Trial ◽  
Sample Size Calculation ◽  
Facilitatory Effect ◽  
Theta Burst Stimulation ◽  
Burst Stimulation ◽  
Randomised Controlled ◽  
Theta Burst

IntroductionIntermittent theta burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation (rTMS), delivered to the ipsilesional primary motor cortex (M1), appears to enhance the brain’s response to rehabilitative training in patients with stroke. However, its clinical utility is highly subject to variability in different protocols. New evidence has reported that preceding iTBS, with continuous theta burst stimulation (cTBS) may stabilise 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 (ie, priming iTBS), in addition to robot-assisted training (RAT), on the improvement of the hemiparetic upper limb functions of stroke patients and to explore potential sensorimotor neuroplasticity using electroencephalography (EEG).Methods and analysisA three-arm, subjects and assessors-blinded, randomised controlled trial will be performed with patients with chronic stroke. An estimated sample of 36 patients will be needed based on the prior sample size calculation. All participants will be randomly allocated to receive 10 sessions of rTMS with different TBS protocols (cTBS+iTBS, sham cTBS+iTBS and sham cTBS+sham iTBS), three to five sessions per week, for 2–3 weeks. All participants will receive 60 min of RAT after each stimulation session. Primary outcomes will be assessed using Fugl-Meyer Assessment-Upper Extremity scores and Action Research Arm Test. Secondary outcomes will be assessed using kinematic outcomes generated during RAT and EEG.Ethics and disseminationEthical approval has been obtained from The Human Subjects Ethics Sub-committee, University Research Committee of The Hong Kong Polytechnic University (reference number: HSEARS20190718003). The results yielded from this study will be presented at international conferences and sent to a peer-review journal to be considered for publication.Trial registration numberNCT04034069.

scholarly journals Treatment of postoperative delirium with continuous theta burst stimulation: study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e048093
Author(s):  
Xiaoyi Wei ◽  
Meijuan Wang ◽  
Xin Ma ◽  
Tianyi Tang ◽  
Jingqing Shi ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Randomised Controlled Trial ◽  
Postoperative Delirium ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Theta Burst Stimulation ◽  
Burst Stimulation ◽  
Randomised Controlled ◽  
Theta Burst ◽  
Continuous Theta Burst Stimulation

IntroductionPostoperative delirium is one of the most common postoperative complications among elderly patients (65 years old or older). However, there are no effective treatments for this condition. Recent research suggests that continuous theta burst stimulation (cTBS), a non-invasive brain stimulation, can reduce pain level, improve cognitive function and affective symptoms in multiple diseases or dysfunctions, including anxiety disorders, major depressive disorder, sleep disorders and pain. But the potential benefits of cTBS in reducing postoperative delirium have not been investigated. Therefore, we propose determining whether cTBS can prevent and/or treat postoperative delirium in senior patients.Methods and analysisThe study will be a double-blind, randomised controlled trial. Participants (65 years old or older) undergoing scheduled orthopaedic surgery (≥2 hours, general anaesthesia) will be randomised to receive either cTBS or sham stimulation with a focal figure-of-eight coil over the right dorsolateral prefrontal cortex at 80% of the resting motor threshold. Every patient will receive 2–3 sets of stimulations during postoperative days (40 s per session, 3 sessions per set, 1 set per day). Participants will be assessed twice daily by a research assistant blinded to allocation. The primary outcome will be the incidence of postoperative delirium measured by the Confusion Assessment Method on postoperative days 1, 2 and 3. The secondary outcomes will be the severity and duration of postoperative delirium, cognitive function, pain, sleep quality, activities of daily living, length of hospital stay, discharge-to-facility or home, and rate of complication and mortality during the hospital stay.Ethics and disseminationEthical approval has been obtained from the ethics committee of Shanghai 10th People’s Hospital. The principal investigator will submit a research progress report to the ethics committee regularly. All participants will provide written informed consent. Study results will be published in a peer-reviewed journal.Trial registration numberNCT04661904.

scholarly journals Intermittent theta burst stimulation applied during early rehabilitation after stroke: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e034088 ◽  
Author(s):  
Lukas Hensel ◽  
Christian Grefkes ◽  
Caroline Tscherpel ◽  
Corinna Ringmaier ◽  
Daria Kraus ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Motor Cortex ◽  
Controlled Trial ◽  
Early Rehabilitation ◽  
Secondary Outcome ◽  
Motor Rehabilitation ◽  
Theta Burst Stimulation ◽  
Burst Stimulation ◽  
Randomised Controlled ◽  
Theta Burst

IntroductionIntermittent theta burst stimulation (iTBS) applied to primary motor cortex (M1) has been shown to modulate both the excitability and connectivity of the motor system. A recent proof-of-principle study, based on a small group of hospitalised patients with acute ischemic stroke, suggested that iTBS applied to the ipsilesional M1 combined with physical therapy early after stroke can amplify motor recovery with lasting after effects. A randomised controlled clinical trial using a double-blind design is warranted to justify the implementation of iTBS-assisted motor rehabilitation in neurorehabilitation from an acute ischaemic stroke.Methods/designWe investigate the effects of daily iTBS on early motor rehabilitation after stroke in an investigator-initiated, longitudinal randomised controlled trial. Patients (n=150) with hemiparesis receive either iTBS (600 pulses) applied to the ipsilesional motor cortex (M1) or a control stimulation (ie, coil placement over the parieto-occipital vertex in parallel to the interhemispheric fissure and with a tilt of 45°). On 8 consecutive workdays, a 45 min arm-centred motor training follows the intervention . The relative grip strength, defined as the grip force ratios of the affected and unaffected hands, serves as the primary outcome parameter. Secondary outcome parameters are measures of arm function (Action Research Arm Test, Fugl-Meyer Motor Scale), stroke severity (National Institutes of Health Stroke Scale), stroke-induced disability (modified Rankin Scale, Barthel Index), duration of inpatient rehabilitation, quality of life (EuroQol 5D), motor evoked potentials and the resting motor threshold of the ipsilesional M1.Ethics and disseminationThe study was approved by the Ethics Commission of the Medical Faculty, University of Cologne, Germany (reference number 15-343). Data will be disseminated through peer-reviewed publications and presentations at conferences. Study title: Theta-Burst Stimulation in Early Rehabilitation after Stroke (acronym: TheSiReS). Study registration at German Registry for Clinical Trials (DRKS00008963) and at ClinicalTrials.gov (NCT02910024).

scholarly journals Accelerated theta burst stimulation for the treatment of depression: A randomised controlled trial

2021 ◽  
Author(s):  
Leo Chen ◽  
Elizabeth HX. Thomas ◽  
Pakin Kaewpijit ◽  
Aleksandra Miljevic ◽  
Rachel Hughes ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Theta Burst Stimulation ◽  
Burst Stimulation ◽  
Treatment Of Depression ◽  
Randomised Controlled ◽  
Theta Burst

scholarly journals Augmented efficacy of intermittent theta burst stimulation on the virtual reality-based cycling training for upper limb function in patients with stroke: a double-blinded, randomized controlled trial

2021 ◽  
Author(s):  
Yu-Hsin Chen ◽  
Chia-Ling Chen ◽  
Ying-Zu Huang ◽  
Hsieh-Ching Chen ◽  
Chung-Yao Chen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Outcome Measures ◽  
Upper Limb ◽  
Controlled Trial ◽  
Theta Burst Stimulation ◽  
Burst Stimulation ◽  
Randomized Controlled ◽  
Theta Burst ◽  
Cycling Training

Abstract Background: Virtual reality and arm cycling have been reported as effective treatment to improve upper limb motor recovery in patients with stroke. Intermittent theta burst stimulation (iTBS) can increase ipsilesional cortical excitability, and has been increasingly used in patients with stroke. However, few studies examined the augmented effect of iTBS on neurorehabilitation program. In this study, we investigated the augmented effect of iTBS on virtual reality-based cycling training (VCT) for upper limb motor function in patients with stroke.Methods: In this randomized controlled trial, 23 patients with stroke were recruited. Each patient received either 15 sessions of iTBS or sham stimulation in addition to VCT on the same day. Outcome measures were assessed before and after the intervention. Co-primary outcome measures for body function were Modified Ashworth Scale Upper Extremity (MAS-UE) and Fugl-Meyer Assessment Upper Extremity (FMA-UE). Secondary outcome measures for activity and participation were Action Research Arm Test (ARAT), Nine Hole Peg Test (NHPT), Box and Block Test (BBT) and Motor Activity Log (MAL), and Stroke Impact Scale (SIS). Paired t test was performed to evaluate the effectiveness after the intervention and analysis of covariance (ANCOVA) was conducted to compare the therapeutic effects between two groups.Results: At post-treatment, both groups showed significant improvement in FMA-UE and ARAT, while only the iTBS group demonstrated significant improvement in MAS-UE, BBT, NHPT, MAL and SIS. ANCOVA revealed that the iTBS group presented greater improvement than the sham group significantly in MAS-UE, NHPT and SIS. However, there were no significant differences in the changes of the FMA-UE, ARAT, BBT, and MAL between groups.Conclusions: Intermittent TBS showed augmented efficacy on VCT for reducing spasticity, improving manual dexterity, and increasing participation in daily life in stroke patients. This study provided an integrated innovative intervention, which may be a promising therapy to improve upper limb motor function recovery, especially manual dexterity, in stroke rehabilitation. However, this study has a small sample size, and thus a further larger-scale study is warranted to confirm the treatment efficacy.Trial registration: This trial was registered under ClinicalTrials.gov ID No. NCT03350087, retrospectively registered, on November 22, 2017.

Theta Burst Stimulation of Human Primary Motor Cortex Degrades Selective Muscle Activation in the Ipsilateral Arm

2010 ◽  
Vol 104 (5) ◽  
pp. 2594-2602 ◽  
Author(s):  
Lynley V. Bradnam ◽  
Cathy M. Stinear ◽  
Winston D. Byblow
Keyword(s):  
Upper Limb ◽  
Muscle Activation ◽  
Primary Motor Cortex ◽  
Biceps Brachii ◽  
Motor Evoked Potentials ◽  
Short Interval ◽  
Relative Size ◽  
Theta Burst Stimulation ◽  
Burst Stimulation ◽  
Theta Burst

This study investigated whether repetitive transcranial magnetic stimulation (TMS) delivered as continuous theta burst stimulation (cTBS) to left M1 degraded selective muscle activation in the contralateral and ipsilateral upper limb in healthy participants. Contralateral motor-evoked potentials (cMEPs) were elicited in left and right biceps brachii (BB) before either elbow flexion or forearm pronation. A neurophysiological index, the excitability ratio (ER), was computed from the relative size of BB cMEPs before each type of movement. Short interval intracortical inhibition (SICI) was assessed in cMEPs of right BB with paired-pulse TMS of left M1. Ipsilateral MEPs (iMEPs) and silent periods (iSPs) were measured in left BB with single-pulse TMS of left M1. Low-intensity cTBS was expected to suppress corticospinal output from left M1. A sham condition was also included. Real but not sham cTBS caused increases in BB ER bilaterally. In the right arm, ER increased because BB cMEPs before flexion were less facilitated, whereas cMEPs in the pronation task were unaffected. This was accompanied by an increase in left M1 SICI. In the left arm, ER increased because BB cMEPs before pronation were facilitated but were unaffected in the flexion task. There was also facilitation of left BB iMEPs. These changes in the left arm are consistent with inappropriate facilitation of left BB α-motoneurons (αMNs) before pronation. This is the first demonstration that cTBS of M1 can alter excitability of neurons controlling ipsilateral proximal musculature and degrade ipsilateral upper limb motor control, providing evidence that ipsilateral and contralateral M1 shape the spatial and temporal characteristics of proximal muscle activation appropriate for the task at hand.

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