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Efficacy of Repetitive Trans-spinal Magnetic Stimulation for Patients with Parkinson's Disease: a Randomised Controlled Trial.

ABSTRACT: We evaluated the effect of repetitive trans-spinal magnetic stimulation (rTSMS) in patients with Parkinson's disease (PD) in a randomised, single-blind study. Participants were hospitalised and administered a single trial of rTSMS or sham treatment 2 days a week for 4 weeks. In addition, all participants underwent rehabilitation 5 days a week for 4 weeks. The primary outcome was the difference between the two groups in the mean change from baseline to post-training in the total score on the Unified Parkinson's Disease Rating Scale (UPDRS). Secondary endpoints included the differences between the two groups in the mean change on the UPDRS part III (motor) score and the Timed Up and Go (TUG) score. Eligible participants were randomly assigned to either the rTSMS group (n = 50) or sham group (n = 50). The between-group difference in mean change in the total UPDRS score was 10.28 (95% confidence interval (CI), 4.42 to 16.13; P = 0.014) immediately after intervention from baseline, 5.04 (95% CI, - 5.41 to 15.50; P = 0.024) 3 months after intervention from baseline and 2.38 (95% CI, 7.18 to 11.85; P = 0.045) 6 months after intervention from baseline. Significant differences between groups in UPDRS part III and TUG scores were maintained more strictly than those in the UPDRS total score. These results strongly indicate that rTSMS promotes the effect of rehabilitation on motor function in patients with PD.

SUBMITTER: Mitsui T

PROVIDER: S-EPMC9587186 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Efficacy of Repetitive Trans-spinal Magnetic Stimulation for Patients with Parkinson's Disease: a Randomised Controlled Trial.

Mitsui Takao T Arii Yoshiharu Y Taniguchi Koichiro K Tsutsumi Satoshi S Takahara Mika M Mabuchi Masaru M Sumitomo Nichika N Matsuura Mieko M Kuroda Yukiko Y

Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics 20220627 4

We evaluated the effect of repetitive trans-spinal magnetic stimulation (rTSMS) in patients with Parkinson's disease (PD) in a randomised, single-blind study. Participants were hospitalised and administered a single trial of rTSMS or sham treatment 2 days a week for 4 weeks. In addition, all participants underwent rehabilitation 5 days a week for 4 weeks. The primary outcome was the difference between the two groups in the mean change from baseline to post-training in the total score on the Unif ...[more]

PMID: 35759108

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Project description:BackgroundRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive form of brain stimulation that positively regulates the motor and non-motor symptoms of Parkinson's disease (PD). Although, most reviews and meta-analysis have shown that rTMS intervention is effective in treating motor symptoms and depression, very few have used randomised controlled trials (RCTs) to analyse the efficacy of this intervention in PD. We aimed to review RCTs of rTMS in patients with PD to assess the efficacy of rTMS on motor and non-motor function in patients with PD.MethodsIn this systematic review and meta-analysis, we searched PubMed, MEDLINE and Web of Science databases for RCTs on rTMS in PD published between January 1, 1988 to January 1, 2022. Eligible studies included sham-controlled RCTs that used rTMS stimulation for motor or non-motor symptoms in PD. RCTs not focusing on the efficacy of rTMS in PD were excluded. Summary data were extracting from those RCTs by two investigators independently. We then calculated standardised mean difference with random-effect models. The main outcome included motor and non-motor examination of scales that were used in PD motor or non-motor assessment. This study was registered with PROSPERO, CRD42022329633.FindingsFourteen studies with 469 patients met the criteria for our meta-analysis. Twelve eligible studies with 381 patients were pooled to analyse the efficacy of rTMS on motor function improvement. The effect size on motor scale scores was 0.51 (P < 0.0001) and were not distinctly heterogeneous (I2 = 29%). Five eligible studies with 202 patients were collected to evaluate antidepressant-like effects. The effect size on depression scale scores was 0.42 (P = 0.004), and were not distinctly heterogeneous (I2 = 25%), indicating a significant anti-depressive effect (P = 0.004). The results suggest that high-frequency of rTMS on primary motor cortex (M1) is effective in improving motor symptoms; while the dorsolateral prefrontal cortex (DLPFC) may be a potentially effective area in alleviating depressive symptom.InterpretationThe findings suggest that rTMS could be used as a possible adjuvant therapy for PD mainly to improve motor symptoms, but could have potential efficacy on depressive symptoms of PD. However, further investigation is needed.FundingThe National Natural Science Foundation of China (NO: 81873777, 82071414), Initiated Foundation of Zhujiang Hospital (NO: 02020318005), Scientific Research Foundation of Guangzhou (NO: 202206010005), and Science and Technology Program of Guangdong of China (NO: 2020A0505100037).

Project description:BackgroundAnorexia nervosa (AN) is associated with morbid fear of fatness, extreme food restriction and altered self-regulation. Neuroimaging data implicate fronto-striatal circuitry, including the dorsolateral prefrontal cortex (DLPFC).MethodsIn this double-blind parallel group study, we investigated the effects of one session of sham-controlled high-frequency repetitive transcranial magnetic stimulation (rTMS) to the left DLPFC (l-DLPFC) in 60 individuals with AN. A food exposure task was administered before and after the procedure to elicit AN-related symptoms.OutcomesThe primary outcome measure was 'core AN symptoms', a variable which combined several subjective AN-related experiences. The effects of rTMS on other measures of psychopathology (e.g. mood), temporal discounting (TD; intertemporal choice behaviour) and on salivary cortisol concentrations were also investigated. Safety, tolerability and acceptability were assessed.ResultsFourty-nine participants completed the study. Whilst there were no interaction effects of rTMS on core AN symptoms, there was a trend for group differences (p = 0.056): after controlling for pre-rTMS scores, individuals who received real rTMS had reduced symptoms post-rTMS and at 24-hour follow-up, relative to those who received sham stimulation. Other psychopathology was not altered differentially following real/sham rTMS. In relation to TD, there was an interaction trend (p = 0.060): real versus sham rTMS resulted in reduced rates of TD (more reflective choice behaviour). Salivary cortisol concentrations were unchanged by stimulation. rTMS was safe, well-tolerated and was considered an acceptable intervention.ConclusionsThis study provides modest evidence that rTMS to the l-DLPFC transiently reduces core symptoms of AN and encourages prudent decision making. Importantly, individuals with AN considered rTMS to be a viable treatment option. These findings require replication in multiple-session studies to evaluate therapeutic efficacy.Trial registrationwww.Controlled-Trials.com ISRCTN22851337.

Project description:BackgroundThe treatment of depression remains a challenge since at least 40% of patients do not respond to initial antidepressant therapy and 20% present chronic symptoms (more than 2 years despite standard treatment administered correctly). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy but still not ideal. Intermittent Theta Burst Stimulation (iTBS), which has only been used recently in clinical practice, could have a faster and more intense effect compared to conventional protocols, including 10-Hz high-frequency rTMS (HF-rTMS). However, no controlled study has so far highlighted the superiority of iTBS in resistant unipolar depression.Methods/designThis paper focuses on the design of a randomised, controlled, double-blind, single-centre study with two parallel arms, carried out in France, in an attempt to assess the efficacy of an iTBS protocol versus a standard HF- rTMS protocol. Sixty patients aged between 18 and 75 years of age will be enrolled. They must be diagnosed with major depressive disorder persisting despite treatment with two antidepressants at an effective dose over a period of 6 weeks during the current episode. The study will consist of two phases: a treatment phase comprising 20 sessions of rTMS to the left dorsolateral prefrontal cortex, localised via a neuronavigation system and a 6-month longitudinal follow-up. The primary endpoint will be the number of responders per group, defined by a decrease of at least 50% in the initial score on the Montgomery and Asberg Rating Scale (MADRS) at the end of rTMS sessions. The secondary endpoints will be: response rate 1 month after rTMS sessions; number of remissions defined by a MADRS score of <8 at the endpoint and 1 month after; the number of responses and remissions maintained over the next 6 months; quality of life; and the presence of predictive markers of the therapeutic response: clinical (dimensional scales), neuropsychological (evaluation of cognitive functions), motor (objective motor testing) and neurophysiological (cortical excitability measurements).DiscussionThe purpose of our study is to check the assumption of iTBS superiority in the management of unipolar depression and we will discuss its effect over time. In case of a significant increase in the number of therapeutic responses with a prolonged effect, the iTBS protocol could be considered a first-line protocol in resistant unipolar depression.Trial registrationClinicalTrials.gov, Identifier NCT02376491 . Registered on 17 February 2015 at http://clinicaltrials.gov .

Project description:Vascular cognitive impairment (VCI) has an increasing prevalence worldwide, accounting for at least 20%-40% of all diagnoses of dementia. The decline in cognitive function seriously impairs patients' activities of daily living and social participation and reduces their quality of life. However, there is still a lack of advanced, definitive rehabilitation programmes for VCI. Hyperbaric oxygen therapy (HBOT) and repetitive transcranial magnetic stimulation (rTMS) are recognised treatments for improving cognitive impairment. The former can restore oxygen supply in the brain by increasing oxygen partial pressure in brain tissue, while the latter can enhance neuronal excitability and promote synaptic plasticity. However, no studies have explored the effect of HBO combined with rTMS on VCI. This study is designed as a single-centre, assessor-blind, randomised controlled clinical trial with four parallel arms. A total of 72 participants will be recruited and randomly assigned to the control group, HBOT group, rTMS group and HBOT combined with rTMS group at a ratio of 1:1:1:1. All enrolled participants will receive conventional treatment. The entire intervention period is 4 weeks, with a 3-week follow-up. Outcomes will be measured at baseline (T0), after a 4-week intervention (T1) and after an additional 3-week follow-up period (T2). The primary endpoint is the Montreal Cognitive Assessment score. The secondary endpoints are Mini-Mental State Examination score, Modified Barthel Index score, latency and amplitude of P300, cerebral cortical oxygenated haemoglobin (HbO2) and deoxygenated haemoglobin (HbR) concentrations as measured by task-state functional near-infrared spectroscopy. Ethics approval was obtained from the West China Hospital Clinical Trials and Biomedical Ethics Committee of Sichuan University (ethics reference: 2022 (1972)). The findings will be published in peer-reviewed journals and disseminated through scientific conferences and seminars. ChiCTR2300068242.

Dataset Information

Efficacy of Repetitive Trans-spinal Magnetic Stimulation for Patients with Parkinson's Disease: a Randomised Controlled Trial.

Publications

Efficacy of Repetitive Trans-spinal Magnetic Stimulation for Patients with Parkinson's Disease: a Randomised Controlled Trial.

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