Dataset Information

Continuous Theta-Burst Stimulation of the Contralesional Primary Motor Cortex for Promotion of Upper Limb Recovery After Stroke: A Randomized Controlled Trial.

ABSTRACT:

Background

Despite improvements in acute stroke therapies and rehabilitation strategies, many stroke patients are left with long-term upper limb motor impairment. We assessed whether an inhibitory repetitive transcranial magnetic stimulation treatment paradigm started within 3 weeks after stroke onset promotes upper limb motor recovery.

Methods

We performed a single-center randomized, sham-controlled clinical trial. Patients with ischemic stroke or intracerebral hemorrhage and unilateral upper limb motor impairment were randomized to 10 daily sessions of active or sham continuous theta-burst stimulation (cTBS) of the contralesional primary motor cortex combined with standard upper limb therapy, started within 3 weeks after stroke onset. The primary outcome was the change in the Action Research Arm Test score from baseline (pretreatment) at 3 months after stroke. Secondary outcomes included the score on the modified Rankin Scale at 3 months and the length of stay at the rehabilitation center. Statistical analyses were performed using mixed models for repeated measures.

Results

We enrolled 60 patients between April 2017 and February 2021, of whom 29 were randomized to active cTBS and 31 to sham cTBS. One patient randomized to active cTBS withdrew consent before the intervention and was excluded from the analyses. The mean difference in the change in Action Research Arm Test score from baseline at 3 months poststroke was 9.6 points ([95% CI, 1.2-17.9]; P=0.0244) in favor of active cTBS. Active cTBS was associated with better scores on the modified Rankin Scale at 3 months (OR, 0.2 [95% CI, 0.1-0.8]; P=0.0225) and with an 18 days shorter length of stay at the rehabilitation center than sham cTBS ([95% CI, 0.0-36.4]; P=0.0494). There were no serious adverse events.

Conclusions

Ten daily sessions of cTBS of the contralesional primary motor cortex combined with upper limb training, started within 3 weeks after stroke onset, promote recovery of the upper limb, reduce disability and dependence and leads to earlier discharge from the rehabilitation center.

Registration

URL: https://trialsearch.who.int/; Unique identifier: NTR6133.

SUBMITTER: Vink JJT

PROVIDER: S-EPMC10358447 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Continuous Theta-Burst Stimulation of the Contralesional Primary Motor Cortex for Promotion of Upper Limb Recovery After Stroke: A Randomized Controlled Trial.

Vink Jord J T JJT van Lieshout Eline C C ECC Otte Willem M WM van Eijk Ruben P A RPA Kouwenhoven Mirjam M Neggers Sebastiaan F W SFW van der Worp H Bart HB Visser-Meily Johanna M A JMA Dijkhuizen Rick M RM

Stroke 20230622 8

<h4>Background</h4>Despite improvements in acute stroke therapies and rehabilitation strategies, many stroke patients are left with long-term upper limb motor impairment. We assessed whether an inhibitory repetitive transcranial magnetic stimulation treatment paradigm started within 3 weeks after stroke onset promotes upper limb motor recovery.<h4>Methods</h4>We performed a single-center randomized, sham-controlled clinical trial. Patients with ischemic stroke or intracerebral hemorrhage and uni ...[more]

PMID: 37345546

Similar Datasets

Project description: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.

Project description:BackgroundOver the past decade, the number of experimental and clinical studies using theta-burst-stimulation (TBS) protocols of transcranial magnetic stimulation (TMS) to modulate brain activity has risen substantially. The use of TBS is motivated by the assumption that these protocols can reliably and lastingly modulate cortical excitability despite their short duration and low number of stimuli. However, this assumption, and thus the experimental validity of studies using TBS, is challenged by recent work showing large inter- and intra-subject variability in response to TBS protocols.ObjectivesTo date, the reproducibility of TBS effects in humans has been exclusively assessed with motor evoked potentials (MEPs), which provide an indirect and limited measure of cortical excitability. Here we combined TMS with electroencephalography (TMS-EEG) and report the first comprehensive investigation of (1) direct TMS-evoked cortical responses to intermittent (iTBS) and continuous TBS (cTBS) of the human motor cortex, and (2) reproducibility of both iTBS- and cTBS-induced cortical response modulation against a robust sham control across repeat visits with commonly used cortical responsivity metrics.ResultsWe show that although single pulse TMS generates stable and reproducible cortical responses across visits, the modulatory effects of TBS vary substantially both between and within individuals. Overall, at the group level, most measures of the iTBS and cTBS-induced effects were not significantly different from sham-TBS. Most importantly, none of the significant TBS-induced effects observed in visit-1 were reproduced in visit-2.ConclusionsOur findings suggest that the generally accepted mechanisms of TBS-induced neuromodulation, i.e. through changes in cortical excitability, may not be accurate. Future research is needed to determine the mechanisms underlying the established therapeutic effects of TBS in neuropsychiatry and examine reproducibility of TBS-induced neuromodulation through oscillatory response dynamics.

Project description:BackgroundUpper limb dysfunction is one of common sequelae of stroke which limits daily activities and decreases quality of life of patients, as well as increasing caregiving burden on families. Theta burst stimulation (TBS) is considered to be a beneficial therapy for post-stroke patients with upper limb motor dysfunction, but there is a lack of a high quality evidence. We aim to investigate the effectiveness and safety of TBS for upper limb motor dysfunction in patients with stroke.MethodsThe following databases will be searched: PubMed, EMBASE, The Cochrane Library, Web of Science, China Biology Medicine (CBM), China National Knowledge infrastructure (CNKI), Technology Periodical Database (VIP) and WanFang Data from the inception to October 2019. All relevant randomized controlled trials (RCTs) using TBS to treat poststroke patients with upper limb motor dysfunction will be included. The primary outcome is Upper Limb Fugl-Meyer Assessment (UL-FMA). Secondary outcomes will include Action Research Arm Test (ARAT), Box and Block Test (BBT), Wolf Motor Function Test (WMFT), Motor Assessment Scale (MAS), Nine Hole Peg Test (NHPT), Grip strength and other scales evaluating the upper limb motor function. Adverse effects will also be evaluated. Two reviewers will screen studies, extract data and assess the risk of bias of included studies independently. Data analysis will be conducted using Review Manager software (RevMan, version 5.3.5) and R software (version 3.6.1).ResultsOur SR will be conducted according to AMSTAR 2.0 and reported in compliance with PRISMA. The findings of this SR will be disseminated through peer-reviewed publications or conference presentations.ConclusionOur study will provide evidence for the effectiveness and safety of theta burst stimulation for upper limb motor dysfunction in patients with stroke.Ethics and disseminationThis systematic review (SR) does not require formal ethical approval since no privacy health information will be included. The findings of this SR will be disseminated through peer-reviewed publications or conference presentations.Prospero registration numberCRD42019142462.

Dataset Information

Continuous Theta-Burst Stimulation of the Contralesional Primary Motor Cortex for Promotion of Upper Limb Recovery After Stroke: A Randomized Controlled Trial.

Background

Methods

Results

Conclusions

Registration

Publications

Continuous Theta-Burst Stimulation of the Contralesional Primary Motor Cortex for Promotion of Upper Limb Recovery After Stroke: A Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets