scholarly journals Using Neurofeedback to Restore Inter-Hemispheric Imbalance: A Study Protocol for Adults With Dyslexia

2021 ◽  
Vol 12 ◽  
Author(s):  
Alice Cancer ◽  
Maria Elide Vanutelli ◽  
Claudio Lucchiari ◽  
Alessandro Antonietti
Keyword(s):  
Clinical Trial ◽  
Study Protocol ◽  
Beta Activity ◽  
Power Ratio ◽  
Experimental Conditions ◽  
Clinical Trial Registration ◽  
Theta Power ◽  
Non Invasive ◽  
Alternative Intervention ◽  
Safety Guidelines

Neurofunctional models of developmental dyslexia (DD) point out disruption of the left-lateralized reading network. In individuals with DD, the left temporo-parietal (TP) regions are underactivated during reading tasks and a dysfunctional activation of the contralateral regions is reported. After a successful reading intervention, left TP lateralization was found to be increased in children with DD. Previous studies measured the effect of modulating the excitability of the left TP cortex using non-invasive brain stimulation (NIBS) in individuals with reading difficulties, showing significant reading improvements. NIBS exclusion criteria and safety guidelines may limit its application in settings without medical supervision and in younger populations. Neurofeedback (NF) training could be an alternative intervention method for modulating the inter-hemispheric balance of the temporal–parietal regions in DD. To date, the effect of NF on reading has been scarcely investigated. Few protocols increasing beta activity in underactivated areas showed improved reading outcomes. However, none of the previous studies designed the NF intervention based on a neurofunctional model of DD. We aim to propose a study protocol for testing the efficacy of a NF training specifically designed for inducing a functional hemispheric imbalance of the tempo-parietal regions in adults with DD. A randomized clinical trial aimed at comparing two experimental conditions is described: (a) Enhancing left beta/theta power ratio NF training in combination with reducing right beta/theta power ratio NF training and (b) sham NF training.Clinical Trial Registration:www.ClinicalTrials.gov, identifier [NCT04989088].

scholarly journals Auricular Neuromodulation for Mass Vagus Nerve Stimulation: Insights From SOS COVID-19 a Multicentric, Randomized, Controlled, Double-Blind French Pilot Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Claire-Marie Rangon ◽  
Régine Barruet ◽  
Abdelmadjid Mazouni ◽  
Chloé Le Cossec ◽  
Sophie Thevenin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vagus Nerve ◽  
Clinical Outcomes ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Treated Patient ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Non Invasive ◽  
The Impact

Importance: An exacerbated inflammatory response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is believed to be one of the major causes of the morbidity and mortality of the coronavirus disease 2019 (COVID-19). Neuromodulation therapy, based on vagus nerve stimulation, was recently hypothesized to control both the SARS-CoV-2 replication and the ensuing inflammation likely through the inhibition of the nuclear factor kappa-light-chain-enhancer of activated B cells pathway and could improve the clinical outcomes as an adjunct treatment. We proposed to test it by the stimulation of the auricular branch of the vagus nerve, i.e., auricular neuromodulation (AN), a non-invasive procedure through the insertion of semipermanent needles on the ears.Objective: The aim of this study was to assess the effect of AN on the clinical outcomes in patients affected by COVID-19.Design, Setting, and Participants: A multicenter, randomized, placebo-controlled, double-blind clinical trial included 31 patients with respiratory failure due to COVID-19 requiring hospitalization. Within 72 h after admission, patients received either AN (n = 14) or sham neuromodulation (SN, n = 15) in addition to the conventional treatments.Main Outcome and Measures: The primary endpoint of the study was the rate of a clinical benefit conferred by AN at Day 14 (D14) as assessed by a 7-point Clinical Progression Scale. The secondary endpoint of the study was the impact of AN on the rate of transfer to the intensive care unit (ICU) and on the survival rate at D14.Results: The AN procedure was well-tolerated without any reported side effects but with no significant improvement for the measures of both primary (p > 0.3) and secondary (p > 0.05) endpoints at the interim analysis. None of the AN-treated patients died but one in the SN group did (81 years). Two AN-treated patients (73 and 79 years, respectively) and one SN-treated patient (59 years) were transferred to ICU. Remarkably, AN-treated patients were older with more representation by males than in the SN arm (i.e., the median age of 75 vs. 65 years, 79% male vs. 47%).Conclusion: The AN procedure, which was used within 72 h after the admission of patients with COVID-19, was safe and could be successfully implemented during the first two waves of COVID-19 in France. Nevertheless, AN did not significantly improve the outcome of the patients in our small preliminary study. It is pertinent to explore further to validate AN as the non-invasive mass vagal stimulation solution for the forthcoming pandemics.Clinical Trial Registration: [https://clinicaltrials.gov/], identifier [NCT04341415].

scholarly journals Effects of Early vs. Late Time-Restricted Eating on Cardiometabolic Health, Inflammation, and Sleep in Overweight and Obese Women: A Study Protocol for the ChronoFast Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Beeke Peters ◽  
Daniela A. Koppold-Liebscher ◽  
Bettina Schuppelius ◽  
Nico Steckhan ◽  
Andreas F. H. Pfeiffer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Body Weight ◽  
Study Protocol ◽  
Well Being ◽  
Cardiometabolic Health ◽  
Oral Glucose ◽  
Late Time ◽  
Obese Women ◽  
Clinical Trial Registration ◽  
Increased Risk

Background: Time-restricted eating is a promising dietary strategy for weight loss, glucose and lipid metabolism improvements, and overall well-being. However, human studies demonstrated contradictory results for the restriction of food intake to the beginning (early TRE, eTRE) or to the end of the day (late TRE, lTRE) suggesting that more carefully controlled studies are needed.Objective: The aim of the ChronoFast trial study is to determine whether eTRE or lTRE is a better dietary approach to improve cardiometabolic health upon minimized calorie deficits and nearly stable body weight.Methods: Here, we present the study protocol of the randomized cross-over ChronoFast clinical trial comparing effects of 2 week eTRE (8:00 to 16:00 h) and lTRE (13:00 to 21:00 h) on insulin sensitivity and other glycemic traits, blood lipids, inflammation, and sleep quality in 30 women with overweight or obesity and increased risk of type 2 diabetes. To ensure timely compliance and unchanged dietary composition, and to minimize possible calorie deficits, real-time monitoring of dietary intake and body weight using a smartphone application, and extensive nutritional counseling are performed. Continuous glucose monitoring, oral glucose tolerance test, 24 h activity tracking, questionnaires, and gene expression analysis in adipose tissue and blood monocytes will be used for assessment of study outcomes.Discussion: The trial will determine whether eTRE or lTRE is more effective to improve cardiometabolic health, elucidate underlying mechanisms, and contribute to the development of recommendations for medical practice and the wider population.Clinical Trial Registration:www.ClinicalTrials.gov, Identifier [NCT04351672]

scholarly journals Non-invasive skin sampling of tryptophan/kynurenine ratio in vitro towards a skin cancer biomarker

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Skaidre Jankovskaja ◽  
Johan Engblom ◽  
Melinda Rezeli ◽  
György Marko-Varga ◽  
Tautgirdas Ruzgas ◽  
...  
Keyword(s):  
Skin Cancer ◽  
Relative Increase ◽  
Cancer Biomarker ◽  
Cancer Diagnostics ◽  
Sampling Time ◽  
Skin Permeability ◽  
Experimental Conditions ◽  
Non Invasive

AbstractThe tryptophan to kynurenine ratio (Trp/Kyn) has been proposed as a cancer biomarker. Non-invasive topical sampling of Trp/Kyn can therefore serve as a promising concept for skin cancer diagnostics. By performing in vitro pig skin permeability studies, we conclude that non-invasive topical sampling of Trp and Kyn is feasible. We explore the influence of different experimental conditions, which are relevant for the clinical in vivo setting, such as pH variations, sampling time, and microbial degradation of Trp and Kyn. The permeabilities of Trp and Kyn are overall similar. However, the permeated Trp/Kyn ratio is generally higher than unity due to endogenous Trp, which should be taken into account to obtain a non-biased Trp/Kyn ratio accurately reflecting systemic concentrations. Additionally, prolonged sampling time is associated with bacterial Trp and Kyn degradation and should be considered in a clinical setting. Finally, the experimental results are supported by the four permeation pathways model, predicting that the hydrophilic Trp and Kyn molecules mainly permeate through lipid defects (i.e., the porous pathway). However, the hydrophobic indole ring of Trp is suggested to result in a small but noticeable relative increase of Trp diffusion via pathways across the SC lipid lamellae, while the shunt pathway is proposed to slightly favor permeation of Kyn relative to Trp.

scholarly journals Effect of noisy galvanic vestibular stimulation on dynamic posture sway under visual deprivation in patients with bilateral vestibular hypofunction

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Po-Yin Chen ◽  
Ying-Chun Jheng ◽  
Chien-Chih Wang ◽  
Shih-En Huang ◽  
Ting-Hua Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Light Exposure ◽  
Light Condition ◽  
Vestibular Stimulation ◽  
Galvanic Vestibular Stimulation ◽  
Lateral Deviation ◽  
Clinical Trial Registration ◽  
Vestibular Hypofunction ◽  
Dark Conditions ◽  
Bilateral Vestibular Hypofunction

AbstractA single-blind study to investigate the effects of noisy galvanic vestibular stimulation (nGVS) in straight walking and 2 Hz head yaw walking for healthy and bilateral vestibular hypofunction (BVH) participants in light and dark conditions. The optimal stimulation intensity for each participant was determined by calculating standing stability on a force plate while randomly applying six graded nGVS intensities (0–1000 µA). The chest–pelvic (C/P) ratio and lateral deviation of the center of mass (COM) were measured by motion capture during straight and 2 Hz head yaw walking in light and dark conditions. Participants were blinded to nGVS served randomly and imperceivably. Ten BVH patients and 16 healthy participants completed all trials. In the light condition, the COM lateral deviation significantly decreased only in straight walking (p = 0.037) with nGVS for the BVH. In the dark condition, both healthy (p = 0.026) and BVH (p = 0.017) exhibited decreased lateral deviation during nGVS. The C/P ratio decreased significantly in BVH for 2 Hz head yaw walking with nGVS (p = 0.005) in light conditions. This study demonstrated that nGVS effectively reduced walking deviations, especially in visual deprived condition for the BVH. Applying nGVS with different head rotation frequencies and light exposure levels may accelerate the rehabilitation process for patients with BVH.Clinical Trial Registration This clinical trial was prospectively registered at www.clinicaltrials.gov with the Unique identifier: NCT03554941. Date of registration: (13/06/2018).

scholarly journals MEBO versus topical Diltiazem versus a combination of both ointments in the treatment of acute anal fissure: a randomized clinical trial protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mohamad Hadi El Charif ◽  
Samer Doughan ◽  
Rawya Kredly ◽  
Sara Kassas ◽  
Rayan Azab ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Wound Healing ◽  
Anal Fissure ◽  
Topical Therapy ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Anal Fissures ◽  
Link Type ◽  
Anorectal Region ◽  
Registration Date

Abstract Background Anal fissure is a common complication of the anorectal region and one of the most reported causes of anal pain. Acute anal fissure can be cured by surgery or medical treatment. There is an increase in the use of topical therapy for the treatment of anal fissures. A common topical drug used is Diltiazem (DTZ), a calcium-channel blocker, which relaxes the anal sphincter and thus promotes healing of the anal fissure. Moist exposed burn ointment (MEBO) is an ointment that is effective for the treatment of burns and wound healing and is becoming popular in the treatment of anal fissures. Methods This is a 1:1:1 randomized, controlled, parallel design, with endpoint measures of change in pain score, wound healing, defecation strain score and patient’s global impression of improvement. The study will be conducted at AUBMC over a 10-week period. Patients will be randomized to three treatment arms: MEBO, Diltiazem, and a combination of MEBO and Diltiazem ointments. Discussion The results of this study will allow physicians to assess the efficacy and safety of MEBO in the treatment of acute anal fissure, and also in comparison to Diltiazem. This trial will generate evidence-based conclusions regarding the use of a herbal/natural-based product (MEBO ointment) for the treatment of anal fissures. Trial registration ClinicalTrials.gov Identifier NCT04153032. Clinical Trial Registration Date: 06-NOVEMBER-2019.

scholarly journals Telerehabilitation Intervention in Patients with COVID-19 after Hospital Discharge to Improve Functional Capacity and Quality of Life. Study Protocol for a Multicenter Randomized Clinical Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 2924
Author(s):  
José-Manuel Pastora-Bernal ◽  
María-José Estebanez-Pérez ◽  
Guadalupe Molina-Torres ◽  
Francisco-José García-López ◽  
Raquel Sobrino-Sánchez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Hospital Discharge ◽  
Study Protocol ◽  
Functional Capacity ◽  
Treatment Method ◽  
Current Evidence ◽  
Current Standard

COVID-19 can cause important sequels in the respiratory system and frequently presents loss of strength, dyspnea, polyneuropathies and multi-organic affectation. Physiotherapy interventions acquire a fundamental role in the recovery of the functions and the quality of life. Regarding the recovery phases after hospital discharge, the current evidence available is very preliminary. Telerehabilitation is presented as a promising complementary treatment method to standard physiotherapy. The main objective of this research is to evaluate the effectiveness of a personalized telerehabilitation intervention after discharge from hospital for the improvement of functional capacity and quality of life compared to a program of health education and/or care in a rehabilitation center. As secondary objectives, to identify the satisfaction and perception of patients with the telerehabilitation intervention and the presence of barriers to its implementation, as well as to evaluate the cost-effectiveness from the perspective of the health system. This study protocol will be carried out through a single blind multicenter randomized clinical trial in the south of Spain. We hypothesize that the implementation of a telerehabilitation program presents results not inferior to those obtained with the current standard intervention. If the hypothesis is confirmed, it would be an opportunity to define new policies and interventions to address this disease and its consequences. Trial registration NCT04742946.

scholarly journals Single-Sided Portable NMR Investigation to Assess and Monitor Cleaning Action of PVA-Borax Hydrogel in Travertine and Lecce Stone

Molecules ◽  
2021 ◽  
Vol 26 (12) ◽  
pp. 3697
Author(s):  
Valeria Stagno ◽  
Chiara Genova ◽  
Nicole Zoratto ◽  
Gabriele Favero ◽  
Silvia Capuani
Keyword(s):  
Pore Size ◽  
Experimental Conditions ◽  
Non Invasive ◽  
Bedding Planes ◽  
Paramagnetic Impurities ◽  
Two Samples ◽  
Action Time ◽  
Paramagnetic Agents ◽  
Portable Nmr ◽  
Non Destructive

In this work, we investigated the potential of PVA-borax hydrogel for cleaning limestones and the dependence of the cleaning on the porosity of the rock and on the action time of the hydrogel treatment. Towards this goal, we used a nuclear magnetic resonance (NMR) spectrometer, developed for non-invasive and non-destructive applications on cultural heritage. T2-NMR parameters were quantified on different samples of Lecce stone and Travertine cut perpendicular (Pe) and parallel (Pa) to the bedding planes under different experimental conditions: untreated samples, treated with Paraloid B72 and cleaned with PVA-PEO-borax hydrogel applied for 4 min and 2 h. The T2 results suggest that the effectiveness of the cleaning strongly depended on the porosity of the stones. In Lecce stone, the hydrogel seemed to eliminate both the paramagnetic impurities (in equal measure with 4 min and 2 h treatment) and Paraloid B72. In Travertine Pe, characterized by a smaller pore size compared to Lecce stone, no significant effects were found regarding both the cleaning and the treatment with Paraloid B72. In Travertine Pa, characterized by a larger pore size than the other two samples, the hydrogel seemed to clean the paramagnetic agents (it worked better if applied for a longer time) but it did not appear to have any effect on Paraloid B72 removal.

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