scholarly journals Efficacy, Safety, and Tolerability of Theta-Burst Stimulation in Mixed Depression: Design, Rationale, and Objectives of a Randomized, Double-Blinded, Sham-Controlled Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Diego Freitas Tavares ◽  
Carla Garcia Rodrigues dos Santos ◽  
Leandro Da Costa Lane Valiengo ◽  
Izio Klein ◽  
Lucas Borrione ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Design Rationale ◽  
Theta Burst Stimulation ◽  
Burst Stimulation ◽  
Double Blinded ◽  
Theta Burst

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.

Cerebellar Theta-Burst Stimulation Combined With Physiotherapy in Subacute and Chronic Stroke Patients: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 35 (1) ◽  
pp. 23-32
Author(s):  
Ling-Yi Liao ◽  
Yun-Juan Xie ◽  
Yi Chen ◽  
Qiang Gao
Keyword(s):  
Sham Group ◽  
Low Cost ◽  
Controlled Trial ◽  
Chronic Stroke ◽  
Motor Recovery ◽  
Theta Burst Stimulation ◽  
Burst Stimulation ◽  
Stroke Patients ◽  
Clinical Trial Registry ◽  
Theta Burst

Background Intermittent theta-burst stimulation (iTBS) has been suggested to improve poststroke rehabilitation. The cerebellum is considered crucial for motor control. However, the effects of cerebellar iTBS with routine physical therapy on balance and motor recovery in subacute and chronic stroke patients have not been explored. Objective To measure the short-term effects of cerebellar iTBS with physiotherapy on the balance and functional outcomes in subacute and chronic stroke patients with hemiparesis. Methods Thirty hemiparetic patients were recruited for this randomized, double-blinded, sham-controlled trial, and randomized into either the treatment or sham group. Both groups participated in physiotherapy 5 times per week for 2 weeks, and cerebellar iTBS or sham iTBS was performed daily, immediately before physiotherapy. The primary outcome was the Berg balance scale (BBS) score. Secondary outcomes included the trunk impairment scale (TIS) score, Fugl-Meyer assessment scale score for lower extremities (FMA-LE), Barthel index (BI), and corticospinal excitability, as measured by transcranial magnetic stimulation. The outcomes were measured before and 1 week and 2 weeks after the intervention. Results Compared with those at baseline, significant increases were identified in all clinical scores (BBS, TIS, FMA-LE, and BI) in both groups after the 2-week intervention. The BBS and TIS scores improved more in the iTBS group than in the sham group. Conclusions Cerebellar iTBS with physiotherapy promotes balance and motor recovery in poststroke patients. Therefore, this method can be used in low-cost, fast, and efficient protocols for stroke rehabilitation (Chinese Clinical Trial Registry: ChiCTR1900026450).

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.

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 Theta-Burst Stimulation for Cognitive Enhancement in Parkinson's Disease With Mild Cognitive Impairment: A Randomized, Double-Blind, Sham-Controlled Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Stefan Lang ◽  
Liu Shi Gan ◽  
Eun Jin Yoon ◽  
Alexandru Hanganu ◽  
Mekale Kibreab ◽  
...  
Keyword(s):  
Executive Function ◽  
Dorsolateral Prefrontal Cortex ◽  
Controlled Trial ◽  
Cognitive Domain ◽  
Theta Burst Stimulation ◽  
Burst Stimulation ◽  
Double Blind ◽  
Dorsolateral Prefrontal ◽  
Z Scores ◽  
Theta Burst

Background: Mild cognitive impairment is a common non-motor symptom of Parkinson's disease (PD-MCI) and has minimal treatment options.Objective: In this double-blind, randomized, sham-controlled trial, we assessed the effect of repeated sessions of intermittent theta-burst stimulation over the left dorsolateral prefrontal cortex on cognition and brain connectivity in subjects with PD-MCI.Methods: Forty-one subjects were randomized to receive real (n = 21) or sham stimulation (n = 20). All subjects underwent neuropsychological assessments before, 1 day, and 1 month after stimulation. Subjects also underwent resting-state functional magnetic resonance imaging before and 48 h after stimulation. The primary outcome was the change in the cognitive domain (executive function, attention, memory, language, and visuospatial abilities) z-scores across time.Results: There was an insignificant effect on cognitive domain z-scores across time when comparing real with sham stimulation and correcting for multiple comparisons across cognitive domains (p > 0.05 Bonferroni correction). However, the real stimulation group demonstrated a trend toward improved executive functioning scores at the 1-month follow-up compared with sham (p < 0.05 uncorrected). After real stimulation, the connectivity of the stimulation site showed decreased connectivity to the left caudate head. There was no change in connectivity within or between the stimulation network (a network of cortical regions connected to the stimulation site) and the striatal network. However, higher baseline connectivity between the stimulation network and the striatal network was associated with improved executive function scores at 1 month.Conclusions: These results suggest that intermittent theta-burst stimulation over the dorsolateral prefrontal cortex in subjects with PD-MCI has minimal effect on cognition compared with sham, although there were trends toward improved executive function. This intervention may be more effective in subjects with higher baseline connectivity between the stimulation network and the striatal network. This trial supports further investigation focusing on executive function and incorporating connectivity-based targeting.Clinical Trial Registration:www.ClinicalTrials.gov, identifier NCT03243214.

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