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Neuropsychological management of multiple sclerosis: evaluation of a supervised and customized cognitive rehabilitation program for self-used at home (SEPIA): protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Cognitive and mood disorders negatively impact daily life in patients with multiple sclerosis (MS). Pharmacological treatments did not demonstrate any effect on cognition compared with cognitive rehabilitation (CR). However, if CR programs offer promising results on cognition, they are less consistent concerning mood and quality of life (QoL). In this context, we designed a randomized controlled trial to evaluate the efficacy of an innovative computerized CR program, conducted at home, on QoL. Secondary objectives will estimate the improvement, or the stabilization over time, of patients' cognitive performances and their emotional affects. METHODS:Forty MS patients (relapsing-remitting or secondary progressive forms) who have cognitive impairment will be recruited for the trial (called SEPIA-NCT03471338) and randomly assigned to either the experimental group or the control group. Patients randomly assigned in the experimental group will perform a home-based CR program with psychological support during eight consecutive weeks. CR will be based on computerized cognitive exercises from the PRESCO® software developed by HAPPYneuron©. Training sessions (three sessions of 45?min per week) will consist of short exercises evaluating a broad range of cognitive domains and will be personalized for each patient (tracking tool and supervised guidance). The control group, designed to control for non-specific elements of the intervention, will receive only psychological support consisting of various issues related to MS, such as everyday cognitive-related difficulties or management of emotions. QoL, assessed by the MUSIQOL (Multiple Sclerosis International Quality Of Life) questionnaire, will be evaluated three times (at baseline and after 1?week and 25?weeks after home-based intervention) as well as secondary outcomes measuring self-esteem, cognition, depression, anxiety, metacognition, fatigue, and sleep quality. Given the expected MUSIQOL variation, the inclusion of 20 patients per group (alpha risk 5% and power 80%) will be required. DISCUSSION:Evidence suggests that computerized programs may be a practice option for CR for people with MS, but there is a paucity of studies evaluating QoL. We hope that this innovative program will highlight such benefits over time in patients' daily life. In the future, such programs will allow a wider range of available therapeutic options for MS patients with cognitive impairment and for practitioners in charge of their care. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT03471338. Retrospectively registered on 25 April 2018. https://clinicaltrials.gov/ct2/show/NCT03471338?term=NCT03471338&cond=Multiple+Sclerosis&draw=2&rank=1 .

SUBMITTER: Harand C

PROVIDER: S-EPMC6819362 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Neuropsychological management of multiple sclerosis: evaluation of a supervised and customized cognitive rehabilitation program for self-used at home (SEPIA): protocol for a randomized controlled trial.

Harand Caroline C Daniel France F Mondou Audrey A Chevanne Damien D Creveuil Christian C Defer Gilles G

Trials 20191029 1

<h4>Background</h4>Cognitive and mood disorders negatively impact daily life in patients with multiple sclerosis (MS). Pharmacological treatments did not demonstrate any effect on cognition compared with cognitive rehabilitation (CR). However, if CR programs offer promising results on cognition, they are less consistent concerning mood and quality of life (QoL). In this context, we designed a randomized controlled trial to evaluate the efficacy of an innovative computerized CR program, conducted ...[more]

PMID: 31665039

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Project description:BackgroundStroke patients usually suffer primary cognitive impairment related to attention, memory, and executive functions. This impairment causes a negative impact on the quality of life of patients and their families, and may be long term. Cognitive rehabilitation has been shown to be an effective way to treat cognitive impairment and should be continued after hospital discharge. Computerized cognitive rehabilitation can be performed at home using exercise programs that advance with predetermined course content, interval, and pace. We hypothesize that computerized rehabilitation might be improved if a program could customize course content and pace in response to patient-specific progress. The present pilot study is a randomized controlled double-blind crossover clinical trial aiming to study if chronic stroke patients with cognitive impairment could benefit from cognitive training through a customized tele-rehabilitation platform ("Guttmann, NeuroPersonalTrainer"®, GNPT®).Methods/designIndividuals with chronic-stage stroke will be recruited. Participants will be randomized to receive experimental intervention (customized tele-rehabilitation platform, GNPT®) or sham intervention (ictus.online), both with the same frequency and duration (five sessions per week over 6 weeks). After a washout period of 3 months, crossover will occur and participants from the GNPT® condition will receive sham intervention, while participants originally from the sham intervention will receive GNPT®. Patients will be assessed before and after receiving each treatment regimen with an exhaustive neuropsychological battery. Primary outcomes will include rating measures that assess attention difficulties, memory failures, and executive dysfunction for daily activities, as well as performance-based measures of attention, memory, and executive functions.DiscussionCustomized cognitive training could lead to better cognitive function in patients with chronic-stage stroke and improve their quality of life.Trial registrationNCT03326349 . Registered 31 October 2017.

Project description:BackgroundPredicting progression from a stage of Mild Cognitive Impairment to dementia is a major pursuit in current research. It is broadly accepted that cognition declines with a continuum between MCI and dementia. As such, cohorts of MCI patients are usually heterogeneous, containing patients at different stages of the neurodegenerative process. This hampers the prognostic task. Nevertheless, when learning prognostic models, most studies use the entire cohort of MCI patients regardless of their disease stages. In this paper, we propose a Time Windows approach to predict conversion to dementia, learning with patients stratified using time windows, thus fine-tuning the prognosis regarding the time to conversion.MethodsIn the proposed Time Windows approach, we grouped patients based on the clinical information of whether they converted (converter MCI) or remained MCI (stable MCI) within a specific time window. We tested time windows of 2, 3, 4 and 5 years. We developed a prognostic model for each time window using clinical and neuropsychological data and compared this approach with the commonly used in the literature, where all patients are used to learn the models, named as First Last approach. This enables to move from the traditional question "Will a MCI patient convert to dementia somewhere in the future" to the question "Will a MCI patient convert to dementia in a specific time window".ResultsThe proposed Time Windows approach outperformed the First Last approach. The results showed that we can predict conversion to dementia as early as 5 years before the event with an AUC of 0.88 in the cross-validation set and 0.76 in an independent validation set.ConclusionsPrognostic models using time windows have higher performance when predicting progression from MCI to dementia, when compared to the prognostic approach commonly used in the literature. Furthermore, the proposed Time Windows approach is more relevant from a clinical point of view, predicting conversion within a temporal interval rather than sometime in the future and allowing clinicians to timely adjust treatments and clinical appointments.

Project description:BackgroundObstructive sleep apnea (OSA) is characterized by recurrent, intermittent partial or complete obstruction of the upper respiratory tract during sleep, which negatively affects the patient's daily quality of life (QoL). Middle-aged and older men who smoke and have obesity are most at risk. Even though the use of continuous positive airway pressure (CPAP) during sleep remains the gold standard treatment, various rehabilitation methods, such as exercise, respiratory therapy, myofunctional therapy, and nutritional lifestyle interventions, also appear to be effective. Moreover, it is increasingly recommended to use alternative or additional therapy options in combination with CPAP therapy.ObjectiveThis study aims to evaluate if a comprehensive home-based, remotely supervised rehabilitation program (tele-RHB), in combination with standard therapy, can improve OSA severity by decreasing the apnea-hypopnea index (AHI); improve objective parameters of polysomnographic, spirometric, anthropometric, and body composition examinations; improve lipid profile, maximal mouth pressure, and functional capacity tests; and enhance the subjective perception of QoL, as well as daytime sleepiness in male participants with moderate to severe OSA. Our hypothesis is that a combination of the tele-RHB program and CPAP therapy will be more effective by improving OSA severity and the abovementioned parameters.MethodsThis randomized controlled trial aims to recruit 50 male participants between the ages of 30 and 60 years with newly diagnosed moderate to severe OSA. Participants will be randomized 1:1, either to a 12-week tele-RHB program along with CPAP therapy or to CPAP therapy alone. After the completion of the intervention, the participants will be invited to complete a 1-year follow-up. The primary outcomes will be the polysomnographic value of AHI, Epworth Sleepiness Scale score, 36-Item Short Form Health Survey (SF-36) score, percentage of body fat, 6-minute walk test distance covered, as well as maximal inspiratory and expiratory mouth pressure values. Secondary outcomes will include polysomnographic values of oxygen desaturation index, supine AHI, total sleep time, average heart rate, mean oxygen saturation, and the percentage of time with oxygen saturation below 90%; anthropometric measurements of neck, waist, and hip circumference; BMI values; forced vital capacity; forced expiratory volume in 1 second; World Health Organization's tool to measure QoL (WHOQOL-BREF) score; and lipid profile values.ResultsStudy recruitment began on October 25, 2021, and the estimated study completion date is December 2024. Analyses will be performed to examine whether the combination of the tele-RHB program and CPAP therapy will be more effective in the reduction of OSA severity and improvement of QoL, body composition and circumferences, exercise tolerance, lipid profile, as well as respiratory muscle and lung function, compared to CPAP therapy alone.ConclusionsThe study will evaluate the effect of a comprehensive tele-RHB program on selected parameters mentioned above in male participants. The results of this intervention could help the further development of novel additional therapeutic home-based options for OSA.Trial registrationClinicalTrials.gov NCT04759456; https://clinicaltrials.gov/ct2/show/NCT04759456.International registered report identifier (irrid)DERR1-10.2196/47460.

Project description:BackgroundCognitive problems affect up to 70% of people with multiple sclerosis (MS), which can negatively impact mood, ability to work, and quality of life. Addressing cognitive problems is a top 10 research priority for people with MS. Our ongoing research has systematically developed a cognitive screening and management pathway (NEuRoMS) tailored for people with MS, involving a brief cognitive evaluation and rehabilitation intervention. The present study aims to assess the feasibility of delivering the pathway and will inform the design of a definitive randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of the intervention and eventually guide its clinical implementation.MethodsThe feasibility study is in three parts. Part 1 involves an observational study of those who receive screening and support for cognitive problems, using routinely collected clinical data. Part 2 is a two-arm, parallel group, multicentre, feasibility RCT with a nested fidelity evaluation. This part will evaluate the feasibility of undertaking a definitive trial comparing the NEuRoMS intervention plus usual care to usual care only, amongst people with MS with mild cognitive problems (n = 60). In part 3, semi-structured interviews will be undertaken with participants from part 2 (n = 25), clinicians (n = 9), and intervention providers (n = 3) involved in delivering the NEuRoMS cognitive screening and management pathway. MS participants will be recruited from outpatient clinics at three UK National Health Service hospitals.DiscussionTimely screening and effective management of cognitive problems in MS are urgently needed due to the detrimental consequences of cognitive problems on people with MS, the healthcare system, and wider society. The NEuRoMS intervention is based on previous and extant literature and has been co-constructed with relevant stakeholders. If effective, the NEuRoMS pathway will facilitate timely identification and management of cognitive problems in people with MS.Trial registrationISRCTN11203922 . Prospectively registered on 09.02.2021.

Project description:BACKGROUND:Computerized cognitive rehabilitation training (CCRT) may be beneficial for alleviating persisting neurocognitive deficits in Ugandan severe malaria survivors. We completed a randomized controlled trial of CCRT for both severe malaria and non-malaria cohorts of children. METHODS:150 school-age severe malaria and 150 non-malaria children were randomized to three treatment arms: 24 sessions of Captain's Log CCRT for attention, working memory and nonverbal reasoning, in which training on each of 9 tasks difficulty increased with proficiency; a limited CCRT arm that did not titrate to proficiency but randomly cycled across the simplest to moderate level of training; and a passive control arm. Before and after 2 months of CCRT intervention and one year following, children were tested with the Kaufman Assessment Battery for Children, 2nd edition (KABC-II), computerized CogState cognitive tests, the Behavior Rating Inventory for Executive Function (BRIEF), and the Achenbach Child Behavior Checklist (CBCL). RESULTS:Malaria children assigned to the limited-CCRT intervention arm were significantly better than passive controls on KABC-II Mental Processing Index (P = 0.04), Sequential Processing (working memory) (P = 0.02) and the Conceptual Thinking subtest (planning/reasoning) (P = 0.02). At one year post-training, the limited CCRT malaria children had more rapid CogState card detection (attention) (P = 0.02), and improved BRIEF Global Executive Index (P = 0.01) as compared to passive controls. Non-malaria children receiving CCRT significantly benefited only on KABC-II Conceptual Thinking (both full- and limited-CCRT; P < 0.01), CogState Groton maze chase and learning (P < 0.01), and CogState card identification (P = 0.05, full CCRT only). Improvements in KABC-II Conceptual Thinking planning subtest for the non-malaria children persisted to one-year follow-up only for the full-CCRT intervention arm. CONCLUSION:For severe malaria survivors, limited CCRT improved attention and memory outcomes more than full CCRT, perhaps because of the greater repetition and practice on relevant training tasks in the absence of the performance titration for full CCRT. There were fewer significant cognitive and behavior benefits for the non-malaria children, with the exception of the planning/reasoning subtest of Conceptual Thinking, with stronger full- compared to limited-CCRT improvements persisting to one-year follow-up.

Project description:ImportanceArthroscopic meniscectomy is one of the most common orthopedic procedures. The optimal postoperative approach remains debated.ObjectiveTo compare outcomes associated with home-based rehabilitation programs (HBP) vs standard inpatient and/or outpatient supervised physical therapy (IOP) following arthroscopic isolated meniscectomy (AM).Data sourcesA systematic literature search was conducted on PubMed, Web of Science, Cochrane Library, and Scopus databases on March 15, 2021. The included studies were published from 1982 to 2019.Study selectionRandomized clinical trials of patients treated with HBP vs IOP after AM were included.Data extraction and synthesisData were independently screened and extracted by 2 authors according to the Preferred Reporting Items for Systematic Reviews (PRISMA) reporting guideline. The meta-analysis was performed using a random-effect model; when an I2 < 25% was observed, the fixed-effect model was used. The Hartung-Knapp correction was applied.Main outcomes and measuresThe primary outcome was the Lysholm score (scale of 0-100 with higher scores indicating better knee function) and secondary outcomes were subjective International Knee Documentation Committee (IKDC) score, knee extension and flexion, thigh girth, horizontal and vertical hop test, and days to return to work, as indicated in the PROSPERO registration. Outcomes were measured in the short-term (ranging from 28 to 50 days) and the midterm (6 months).ResultsIn this meta-analysis of 8 RCTs including 434 patients, IOP was associated with a greater short-term improvement in Lysholm score compared with HBP, with a mean difference of -8.64 points (95% CI, -15.14 to -2.13 points; P = .02) between the 2 approached, but the sensitivity analysis showed no difference. Similarly, no statistically significant difference was detected at midterm for Lysholm score, with a mean difference between groups of -4.78 points (95% CI, -9.98 to 0.42 points; P = .07). HBP was associated with a greater short-term improvement in thigh girth, with a mean difference between groups of 1.38 cm (95% CI, 0.27 to 2.48 cm; P = .01), whereas IOP was associated with a better short-term vertical hop score, with a mean difference between groups of -3.25 cm (95% CI, -6.20 to -0.29 cm; P = .03). No differences were found for all the other secondary outcomes.Conclusions and relevanceNo intervention was found to be superior in terms of physical and functional outcomes as well as work-related and patient-reported outcomes, both at short-term and midterm follow-up. Overall, these results suggest that HBP may be an effective management approach after AM in the general population.

Dataset Information

Neuropsychological management of multiple sclerosis: evaluation of a supervised and customized cognitive rehabilitation program for self-used at home (SEPIA): protocol for a randomized controlled trial.

Publications

Neuropsychological management of multiple sclerosis: evaluation of a supervised and customized cognitive rehabilitation program for self-used at home (SEPIA): protocol for a randomized controlled trial.

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