scholarly journals Neuromodulation complementary to physiotherapy in fibromyalgia and its electroencephalographic correlates: a randomized clinical trial protocol

2020 ◽  
Vol 9 (9) ◽  
pp. e292996799
Author(s):  
Géssika Araújo de Melo ◽  
Eliane Araújo de Oliveira ◽  
Suellen Mary Marinho dos Santos Andrade ◽  
Nelso Torro

The objective of the present research is to present a protocol for a randomized, placebo-controlled triple-blind clinical trial, which will evaluate the effects of neuromodulation with transcranial direct current stimulation (tDCS) associated with physiotherapy treatment in fibromyalgia and its electroencephalographic correlates. The volunteers will be women diagnosed with fibromyalgia for at least three months, aged between 40 and 55 years. Participants will be randomly assigned to three groups: Group 1, with anodic stimulation in the left motor cortex and cathodic stimulation in the right supraorbital region; Group 2, with anodic stimulation in the left dorsolateral prefrontal cortex and cathodic stimulation in the right supraorbital region; and Group 3, with simulated type stimulation (sham). All groups will be accompanied by physiotherapy treatment. The primary outcomes will be the variations in pain, anxiety and depression levels, resulting from neuromodulation, as assessed by the Visual Analogue Scale and Beck's Anxiety and Depression Inventories, respectively. The secondary outcome will be the evaluation of the cortical electrical activity as registered by a 32-channel electroencephalogram. In data analysis, a mixed ANOVA will be used, with 3 groups of participants versus 2 moments of evaluation, with a level of significance of p<0.05. For pair comparisons, post hoc test with Bonferroni-Sidak correction will be used. Considering that fibromyalgia is a multifactorial disease, not very responsive to drugs and other conventional treatments, it is important to analyze the potential therapeutic effect of neuromodulation, in addition to the physiotherapeutic treatment, in individuals with fibromyalgia.

2021 ◽  
pp. 155005942110221
Author(s):  
Hossein Mostafavi ◽  
Mohsen Dadashi ◽  
Alireza Faridi ◽  
Fatemeh Kazemzadeh ◽  
Zakaria Eskandari

Objective. This study aimed to investigate the effect of bilateral transcranial direct current stimulation (tDCS) on the electroencephalography (EEG) amplitude and coherence in male patients with opioid use disorder (OUD), who were under methadone therapy. It compares the effects of active versus sham tDCS. Methods. This is a double-blind sham-controlled clinical trial. Participants were 30 male patients with OUD; they were divided into 3 groups of left anode/right cathode tDCS, right anode/left cathode tDCS, and sham tDCS. Their brainwave activity was measured by quantitative EEG before study and then active groups underwent tDCS (2 mA, 20 min) applied over their right/left dorsolateral prefrontal cortex (DLPFC) for 10 consecutive days. After stimulation, they were re-assessed. The collected data were analyzed in SPSS, MATLAB, and NeuroGuide v.2 applications. Results. After active tDCS, a significant decrease in amplitude of slow brain waves (delta, theta, and alpha) in prefrontal, frontal, occipital, and parietal areas, and an increase in the coherence of beta, delta, and theta frequency bands in the parietal, central, and temporal regions of addicts were reported. In the sham group, there was a significant decrease in the amplitude of the alpha wave and in the coherence of delta and theta waves. Conclusion. The active tDCS over the right/left DLPFC, as a noninvasive and complementary treatment, can modulate the amplitude and coherence of brainwaves in patients with OUD.


Author(s):  
A. I. Tretiakova ◽  
L. L. Chebotariova ◽  
L. M. Sulii ◽  
V. L. Matrenytskiy

23 patients with clinically proven diagnosis of depression were treated with the help of rTMS. The signs of depression were assessed according to the Hospital Anxiety and Depression Scale (HADS) and Zung Self-Rating Depression Scale. The low-frequency (1 Hz) rTMS was conducted on “Neuro-MS/T” with the intensity of 80% from the threshold of motor response to the TMS of the right dorsolateral prefrontal cortex, number of trains – 60, duration – 23 minutes. After 10 sessions of rTMS, the patients noted the improvement of sleep (15), mood improvement (19), a calmer reaction to stressful situations (14). A reduction of depression severity according to assessment scales was also registered (р < 0,05). The therapeutic rTMS method and the chosen protocol of stimulation proved to be effective in treatment of depression and can be used in medical practice under the control of psychotherapist. 23 patients with clinically proven diagnosis of depression were treated with the help of rTMS. The signs of depression were assessed according to the Hospital Anxiety and Depression Scale (HADS) and Zung Self-Rating Depression Scale. The low-frequency (1 Hz) rTMS was conducted on “Neuro-MS/T” with the intensity of 80% from the threshold of motor response to the TMS of the right dorsolateral prefrontal cortex, number of trains – 60, duration – 23 minutes. After 10 sessions of rTMS, the patients noted the improvement of sleep (15), mood improvement (19), a calmer reaction to stressful situations (14). A reduction of depression severity according to assessment scales was also registered (р < 0,05). The therapeutic rTMS method and the chosen protocol of stimulation proved to be effective in treatment of depression and can be used in medical practice under the control of psychotherapist. 23 patients with clinically proven diagnosis of depression were treated with the help of rTMS. The signs of depression were assessed according to the Hospital Anxiety and Depression Scale (HADS) and Zung Self-Rating Depression Scale. The low-frequency (1 Hz) rTMS was conducted on “Neuro-MS/T” with the intensity of 80% from the threshold of motor response to the TMS of the right dorsolateral prefrontal cortex, number of trains – 60, duration – 23 minutes. After 10 sessions of rTMS, the patients noted the improvement of sleep (15), mood improvement (19), a calmer reaction to stressful situations (14). A reduction of depression severity according to assessment scales was also registered (р < 0,05). The therapeutic rTMS method and the chosen protocol of stimulation proved to be effective in treatment of depression and can be used in medical practice under the control of psychotherapist. 23 patients with clinically proven diagnosis of depression were treated with the help of rTMS. The signs of depression were assessed according to the Hospital Anxiety and Depression Scale (HADS) and Zung Self-Rating Depression Scale. The low-frequency (1 Hz) rTMS was conducted on “Neuro-MS/T” with the intensity of 80% from the threshold of motor response to the TMS of the right dorsolateral prefrontal cortex, number of trains – 60, duration – 23 minutes. After 10 sessions of rTMS, the patients noted the improvement of sleep (15), mood improvement (19), a calmer reaction to stressful situations (14). A reduction of depression severity according to assessment scales was also registered (р < 0,05). The therapeutic rTMS method and the chosen protocol of stimulation proved to be effective in treatment of depression and can be used in medical practice under the control of psychotherapist. 23 patients with clinically proven diagnosis of depression were treated with the help of rTMS. The signs of depression were assessed according to the Hospital Anxiety and Depression Scale (HADS) and Zung Self-Rating Depression Scale. The low-frequency (1 Hz) rTMS was conducted on “Neuro-MS/T” with the intensity of 80% from the threshold of motor response to the TMS of the right dorsolateral prefrontal cortex, number of trains – 60, duration – 23 minutes. After 10 sessions of rTMS, the patients noted the improvement of sleep (15), mood improvement (19), a calmer reaction to stressful situations (14). A reduction of depression severity according to assessment scales was also registered (р < 0,05). The therapeutic rTMS method and the chosen protocol of stimulation proved to be effective in treatment of depression and can be used in medical practice under the control of psychotherapist.


Author(s):  
A. I. Tretiakova ◽  
L. L. Chebotariova ◽  
L. M. Sulii ◽  
V. L. Matrenytskiy

23 patients with clinically proven diagnosis of depression were treated with the help of rTMS. The signs of depression were assessed according to the Hospital Anxiety and Depression Scale (HADS) and Zung Self-Rating Depression Scale. The low-frequency (1 Hz) rTMS was conducted on “Neuro-MS/T” with the intensity of 80% from the threshold of motor response to the TMS of the right dorsolateral prefrontal cortex, number of trains – 60, duration – 23 minutes. After 10 sessions of rTMS, the patients noted the improvement of sleep (15), mood improvement (19), a calmer reaction to stressful situations (14). A reduction of depression severity according to assessment scales was also registered (р < 0,05). The therapeutic rTMS method and the chosen protocol of stimulation proved to be effective in treatment of depression and can be used in medical practice under the control of psychotherapist. 23 patients with clinically proven diagnosis of depression were treated with the help of rTMS. The signs of depression were assessed according to the Hospital Anxiety and Depression Scale (HADS) and Zung Self-Rating Depression Scale. The low-frequency (1 Hz) rTMS was conducted on “Neuro-MS/T” with the intensity of 80% from the threshold of motor response to the TMS of the right dorsolateral prefrontal cortex, number of trains – 60, duration – 23 minutes. After 10 sessions of rTMS, the patients noted the improvement of sleep (15), mood improvement (19), a calmer reaction to stressful situations (14). A reduction of depression severity according to assessment scales was also registered (р < 0,05). The therapeutic rTMS method and the chosen protocol of stimulation proved to be effective in treatment of depression and can be used in medical practice under the control of psychotherapist. 23 patients with clinically proven diagnosis of depression were treated with the help of rTMS. The signs of depression were assessed according to the Hospital Anxiety and Depression Scale (HADS) and Zung Self-Rating Depression Scale. The low-frequency (1 Hz) rTMS was conducted on “Neuro-MS/T” with the intensity of 80% from the threshold of motor response to the TMS of the right dorsolateral prefrontal cortex, number of trains – 60, duration – 23 minutes. After 10 sessions of rTMS, the patients noted the improvement of sleep (15), mood improvement (19), a calmer reaction to stressful situations (14). A reduction of depression severity according to assessment scales was also registered (р < 0,05). The therapeutic rTMS method and the chosen protocol of stimulation proved to be effective in treatment of depression and can be used in medical practice under the control of psychotherapist. 23 patients with clinically proven diagnosis of depression were treated with the help of rTMS. The signs of depression were assessed according to the Hospital Anxiety and Depression Scale (HADS) and Zung Self-Rating Depression Scale. The low-frequency (1 Hz) rTMS was conducted on “Neuro-MS/T” with the intensity of 80% from the threshold of motor response to the TMS of the right dorsolateral prefrontal cortex, number of trains – 60, duration – 23 minutes. After 10 sessions of rTMS, the patients noted the improvement of sleep (15), mood improvement (19), a calmer reaction to stressful situations (14). A reduction of depression severity according to assessment scales was also registered (р < 0,05). The therapeutic rTMS method and the chosen protocol of stimulation proved to be effective in treatment of depression and can be used in medical practice under the control of psychotherapist. 23 patients with clinically proven diagnosis of depression were treated with the help of rTMS. The signs of depression were assessed according to the Hospital Anxiety and Depression Scale (HADS) and Zung Self-Rating Depression Scale. The low-frequency (1 Hz) rTMS was conducted on “Neuro-MS/T” with the intensity of 80% from the threshold of motor response to the TMS of the right dorsolateral prefrontal cortex, number of trains – 60, duration – 23 minutes. After 10 sessions of rTMS, the patients noted the improvement of sleep (15), mood improvement (19), a calmer reaction to stressful situations (14). A reduction of depression severity according to assessment scales was also registered (р < 0,05). The therapeutic rTMS method and the chosen protocol of stimulation proved to be effective in treatment of depression and can be used in medical practice under the control of psychotherapist.


2015 ◽  
pp. 214-228 ◽  

Objective: To describe the design and methodology of the Convergence Insufficiency Treatment Trial: Attention and Reading Trial (CITT-ART), the first randomized clinical trial evaluating the effect of vision therapy on reading and attention in school-age children with symptomatic convergence insufficiency (CI). Methods: CITT-ART is a multicenter, placebo-controlled, randomized clinical trial of 324 children ages 9 to 14 years in grades 3 to 8 with symptomatic CI. Participants are randomized to 16 weeks of office-based vergence/accommodative therapy (OBVAT) or placebo therapy (OBPT), both supplemented with home therapy. The primary outcome measure is the change in the Wechsler Individual Achievement Test-Version 3 (WIAT-III) reading comprehension subtest score. Secondary outcome measures are changes in attention as measured by the Strengths and Weaknesses of Attention (SWAN) as reported by parents and teachers, tests of binocular visual function, and other measures of reading and attention. The long-term effects of treatment are assessed 1 year after treatment completion. All analyses will test the null hypothesis of no difference in outcomes between the two treatment groups. The study is entering its second year of recruitment. The final results will contribute to a better understanding of the relationship between the treatment of symptomatic CI and its effect on reading and attention. Conclusion: The study will provide an evidence base to help parents, eye professionals, educators, and other health care providers make informed decisions as they care for children with CI and reading and attention problems. Results may also generate additional hypothesis and guide the development of other scientific investigations of the relationships between visual disorders and other developmental disorders in children.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.


2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
M Cabral ◽  
R Santos ◽  
F Januario ◽  
A Antunes ◽  
R Fonseca-Pinto

Abstract Funding Acknowledgements Type of funding sources: None. Cardiac rehabilitation (CR) has well known beneficial effects on physical capacity, health-related quality of life, morbidity and mortality following an acute cardiac event. It is also known that smoking status is a powerful predictor of recurrent cardiovascular disease events. However, it has been noted that smoker patients may be less likely to access or complete CR. The aim of this study was to determine the levels of anxiety and depression and its improvement, depending on the smoking status of patients with coronary artery disease (CAD) on phase 2 of the Cardiac Rehabilitation Program (CRP). Additionally, we intend to investigate the mental health impact on smoker patients" group in conventional CR versus telemonitored CR. A retrospective study was conducted and patients in CRP between 2017 and 2020 were included. Patient selection and information collection were obtained through medical records. The outcomes of anxiety and depression were evaluated through the Hospital Anxiety and Depression Scale (HADS). Patients were divided into two groups: group 1 for non-smokers or ex-smokers and group 2 for smokers. For group 2 patients, a sub-analysis was performed for patients following the conventional CR versus the telemonitored CR, with the use of MOVIDA mobile application. Variables were analysed in the beginning (T0) and in the end (T1) of phase 2, around 3 months after. Group comparisons tests and statistical analysis were performed using SPSS software v25.0. A p-value less than 0.05 is statistically significant.  We analysed 107 patients, which 93 of these were assiduous and 69 concluded the phase 2 of CRP: 39 patients in group 1 and 30 patients in group 2. Two groups have similar baseline characteristics, except for the higher presence of diabetes (p = 0.02) in group 1. It was noted an improvement in both anxiety and depression items for group 1 (p &lt; 0.01 for both), but only for anxiety item for group 2 (p = 0.03). In subgroup analysis, we observed no improvement for smoking patients following the conventional CR for both anxiety and depression items (p = 0.60 and p = 0.71, respectably) versus a significant difference in telemonitored CR patients (p = 0.02 and p = 0.04). We hypothesise that, when compared to conventional CR, cardiac telemonitored exercise using modern communication methods may result in an improved mental health state among smoking patients, which can lead to a better adherence for CRP. Further studies including more patients and phase 3 of CRP are needed to confirm these results.


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041458
Author(s):  
Vicki Anderson ◽  
Vanessa C Rausa ◽  
Nicholas Anderson ◽  
Georgia Parkin ◽  
Cathriona Clarke ◽  
...  

IntroductionWhile most children recover from a concussion shortly after injury, approximately 30% experience persistent postconcussive symptoms (pPCS) beyond 1-month postinjury. Existing research into the treatment of pPCS have evaluated unimodal approaches, despite evidence suggesting that pPCS likely represent an interaction across various symptom clusters. The primary aim of this study is to evaluate the effectiveness of a multimodal, symptom-tailored intervention to accelerate symptom recovery and increase the proportion of children with resolved symptoms at 3 months postconcussion.Methods and analysisIn this open-label, assessor-blinded, randomised clinical trial, children with concussion aged 8–18 years will be recruited from The Royal Children’s Hospital (The RCH) emergency department, or referred by a clinician, within 17 days of initial injury. Based on parent ratings of their child’s PCS at ~10 days postinjury, symptomatic children (≥2 symptoms at least 1-point above those endorsed preinjury) will undergo a baseline assessment at 3 weeks postinjury and randomised into either Concussion Essentials (CE, n=108), a multimodal, interdisciplinary delivered, symptom-tailored treatment involving physiotherapy, psychology and education, or usual care (UC, n=108) study arms. CE participants will receive 1 hour of intervention each week, for up to 8 weeks or until pPCS resolve. A postprogramme assessment will be conducted at 3 months postinjury for all participants. Effectiveness of the CE intervention will be determined by the proportion of participants for whom pPCS have resolved at the postprogramme assessment (primary outcome) relative to the UC group. Secondary outcome analyses will examine whether children receiving CE are more likely to demonstrate resolution of pPCS, earlier return to normal activity, higher quality of life and a lower rate of utilisation of health services, compared with the UC group.Ethics and disseminationEthics were approved by The RCH Human Research Ethics Committee (HREC: 37100). Parent, and for mature minors, participant consent, will be obtained prior to commencement of the trial. Study results will be disseminated at international conferences and international peer-reviewed journals.Trial registration numberACTRN12617000418370; pre-results.


BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e036494
Author(s):  
Barbara Gugała

ObjectivesTo assess the relationship between caregiver burden and severity of symptoms of anxiety/depression in parents of children with cerebral palsy (CP), and to identify factors differentiating the level of caregiver burden.SettingRegional rehabilitation centres in South-Eastern Poland.ParticipantsThe study involved 190 parents of children with CP, that is, 138 women and 52 men.Primary and secondary outcome measuresCaregiver burden was assessed using Caregiver Burden Scale (CBS), while the intensity of anxiety and depression symptoms was measured using Hospital Anxiety and Depression Scale (HADS). Potential predictors were examined using Gross Motor Function Classification System for Cerebral Palsy (GMFCS), Barthel Index (BI) as well as a questionnaire focusing on the characteristics of the child, the parent and the family. The analyses applied Pearson’s linear correlation coefficient as well as multiple regression analysis.ResultsAll the CBS measures are significantly correlated to HADS-A (anxiety) and HADS-D (depression). Intensity of anxiety is most visibly linked to CBS measures of disappointment and environment (p<0.0001), while severity of depression is related to emotional involvement and general strain (p<0.0001). The factors differentiating caregiver burden measure in the subscales of general strain (p<0.0001) and social isolation (p<0.0001) include the child’s age and BI, and the parent’s health status; in the subscale of disappointment (p<0.0001)—the child’s age, BI, GMFCS, as well as the parent’s age and health status; in the subscale of emotional involvement (p=0.0007)—BI, and the parent’s health status; in the subscale of environment (p=0.0002)—the child’s age and BI.ConclusionsThere is a positive linear relationship between the caregiver burden measures and severity of anxiety and depression. Effort should be made to relieve caregiver burden in parents of children with CP.


2021 ◽  
pp. 1-9
Author(s):  
Haeme R.P. Park ◽  
Miranda R. Chilver ◽  
Arthur Montalto ◽  
Javad Jamshidi ◽  
Peter R. Schofield ◽  
...  

Abstract Background Although mental wellbeing has been linked with positive health outcomes, including longevity and improved emotional and cognitive functioning, studies examining the underlying neural mechanisms of both subjective and psychological wellbeing have been sparse. We assessed whether both forms of wellbeing are associated with neural activity engaged during positive and negative emotion processing and the extent to which this association is driven by genetics or environment. Methods We assessed mental wellbeing in 230 healthy adult monozygotic and dizygotic twins using a previously validated questionnaire (COMPAS-W) and undertook functional magnetic resonance imaging during a facial emotion viewing task. We used linear mixed models to analyse the association between COMPAS-W scores and emotion-elicited neural activation. Univariate twin modelling was used to evaluate heritability of each brain region. Multivariate twin modelling was used to compare twin pairs to assess the contributions of genetic and environmental factors to this association. Results Higher levels of wellbeing were associated with greater neural activity in the dorsolateral prefrontal cortex, localised in the right inferior frontal gyrus (IFG), in response to positive emotional expressions of happiness. Univariate twin modelling showed activity in the IFG to have 20% heritability. Multivariate twin modelling suggested that the association between wellbeing and positive emotion-elicited neural activity was driven by common variance from unique environment (r = 0.208) rather than shared genetics. Conclusions Higher mental wellbeing may have a basis in greater engagement of prefrontal neural regions in response to positive emotion, and this association may be modifiable by unique life experiences.


2021 ◽  
Vol 11 (4) ◽  
pp. 483
Author(s):  
Tatsunori Watanabe ◽  
Nami Kubo ◽  
Xiaoxiao Chen ◽  
Keisuke Yunoki ◽  
Takuya Matsumoto ◽  
...  

The purpose of this pilot study was to investigate whether transcranial static magnetic field stimulation (tSMS), which can modulate cortical excitability, would influence inhibitory control function when applied over the dorsolateral prefrontal cortex (DLPFC). Young healthy adults (n = 8, mean age ± SD = 24.4 ± 4.1, six females) received the following stimulations for 30 min on different days: (1) tSMS over the left DLPFC, (2) tSMS over the right DLPFC, and (3) sham stimulation over either the left or right DLPFC. The participants performed a Go/NoGo task before, immediately after, and 10 min after the stimulation. They were instructed to extend the right wrist in response to target stimuli. We recorded the electromyogram from the right wrist extensor muscles and analyzed erroneous responses (false alarm and missed target detection) and reaction times. As a result, 50% of the participants made erroneous responses, and there were five erroneous responses in total (0.003%). A series of statistical analyses revealed that tSMS did not affect the reaction time. These preliminary findings suggest the possibility that tSMS over the DLPFC is incapable of modulating inhibitory control and/or that the cognitive load imposed in this study was insufficient to detect the effect.


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