Strengthening Mental Abilities with Relational Training (SMART) in Multiple Sclerosis (MS): Study Protocol for a Feasibility Randomised Controlled Trial

Author(s):  
Nima Moghaddam ◽  
David L Dawson ◽  
Nikos Evangelou ◽  
James Turton ◽  
Annie Hawton ◽  
...  

Abstract Background Multiple Sclerosis (MS) is a chronic condition of the central nervous system, affecting around 1 in every 600 people in the UK, with 130 new diagnoses every week. Cognitive difficulties are common amongst people with MS, with up to 70% experiencing deficits in higher-level brain functions – such as planning and problem-solving, attention, and memory. Cognitive deficits make it difficult for people with MS to complete everyday tasks and limit their abilities to work, socialise, and live independently. There is a clear need – and recognised research priority – for treatments that can improve cognitive functioning in people with MS. The absence of effective cognitive interventions exacerbates burdens on the services accessed by people with MS – requiring these services to manage sequelae of untreated cognitive deficits, including reduced quality of life, greater disability and dependence, and poorer adherence to disease-modifying treatments. Our planned research will fill the evidence gap through developing – and examining the feasibility of trialling – a novel online cognitive rehabilitation programme for people with MS (SMART). Methods The primary objective of this study aims to conduct a feasibility study to inform development of a definitive trial of SMART for improving cognitive functioning in people with MS. Secondary objectives include accessing the acceptability to participants of the intervention, delivery format, inclusion/exclusion criteria, baselines and outcome measures, randomisation protocol, and the study procedures. It will further assess the framework for a cost-effectiveness analysis alongside a definitive trial; participant recruitment and retention rates, sample-size needed for a fully powered trial, and signal of efficacy. Discussion As a feasibility trial, outcomes are unlikely to immediately effect changes to NHS practice. However, this is a necessary step towards developing a definitive trial – and will give us a signal of efficacy, a prerequisite for progression to a definitive trial. If found to be clinically- and cost-effective, the latter trial could create a step-change in MS cognitive rehabilitation – improving service-delivery and optimising support with limited additional resources. Trial Registration: Registration ID: ClnicalTrials.gov: NCT04975685 – registered on July 23rd, 2021 Protocol version: 2.0, 25 November 2021

Trials ◽  
2015 ◽  
Vol 16 (1) ◽  
Author(s):  
Nadina B. Lincoln ◽  
Roshan das Nair ◽  
Lucy Bradshaw ◽  
Cris S. Constantinescu ◽  
Avril E. R. Drummond ◽  
...  

Neurology ◽  
2018 ◽  
Vol 90 (6) ◽  
pp. 278-288 ◽  
Author(s):  
James F. Sumowski ◽  
Ralph Benedict ◽  
Christian Enzinger ◽  
Massimo Filippi ◽  
Jeroen J. Geurts ◽  
...  

Cognitive decline is recognized as a prevalent and debilitating symptom of multiple sclerosis (MS), especially deficits in episodic memory and processing speed. The field aims to (1) incorporate cognitive assessment into standard clinical care and clinical trials, (2) utilize state-of-the-art neuroimaging to more thoroughly understand neural bases of cognitive deficits, and (3) develop effective, evidence-based, clinically feasible interventions to prevent or treat cognitive dysfunction, which are lacking. There are obstacles to these goals. Our group of MS researchers and clinicians with varied expertise took stock of the current state of the field, and we identify several important practical and theoretical challenges, including key knowledge gaps and methodologic limitations related to (1) understanding and measurement of cognitive deficits, (2) neuroimaging of neural bases and correlates of deficits, and (3) development of effective treatments. This is not a comprehensive review of the extensive literature, but instead a statement of guidelines and priorities for the field. For instance, we provide recommendations for improving the scientific basis and methodologic rigor for cognitive rehabilitation research. Toward this end, we call for multidisciplinary collaborations toward development of biologically based theoretical models of cognition capable of empirical validation and evidence-based refinement, providing the scientific context for effective treatment discovery.


2011 ◽  
Vol 18 (4) ◽  
pp. 489-497 ◽  
Author(s):  
P Hämäläinen ◽  
A Ikonen ◽  
A Romberg ◽  
H Helenius ◽  
J Ruutiainen

Background: Heat sensitivity and cognitive deficits are typical manifestations of multiple sclerosis (MS). Although cognitive deficits are quite well characterized, practically no data exist on the effects of heat on cognitive performances in MS. Objective: To assess the effects of short-term heat stress on cognitive functioning in subjects with MS. Methods: A total of 23 heat-sensitive MS and 19 healthy control (HC) subjects participated. Moderate heat exposure took place in a Finnish sauna. Cognitive functioning was measured with tests of sustained attention and processing speed, the Paced Auditory Serial Addition Test (PASAT 3” and 2”) and the computerized visual vigilance test, before, during and after heat exposure. Results: During the heat exposure, the core body temperature of the MS group rose significantly more ( p = 0.002) than that of the HC group. The heat stress worsened the performance of the MS group in the PASAT 3” ( p = 0.025) but not in the other cognitive measures. The performance in the PASAT 3” was reversed almost to the baseline level only 1- h after the heat exposure. Conclusions: A significant increase in core body temperature during heat stress is associated with a mild and reversible worsening of the PASAT 3” performance, while visual vigilance performance seems to remain almost unaffected.


2019 ◽  
Vol 21 (7) ◽  
pp. 911-922 ◽  
Author(s):  
Sophie J M Rijnen ◽  
Ikram Meskal ◽  
Marjan Bakker ◽  
Wouter De Baene ◽  
Geert-Jan M Rutten ◽  
...  

Abstract Background Meningioma patients are known to face cognitive deficits before and after surgery. We examined individual changes in cognitive performance over time and identified preoperative predictors of cognitive functioning 12 months after surgery in a large sample of meningioma patients. Methods Patients underwent neuropsychological assessment (NPA) using CNS Vital Signs 1 day before (T0) and 3 (T3) and 12 (T12) months after surgery. Patients’ sociodemographically corrected scores on 7 cognitive domains were compared with performance of a normative sample using one-sample z tests and chi-square tests of independence. Reliable change indices with correction for practice effects were calculated for individual patients. Linear mixed effects models were used to identify preoperative predictors of performance at T12. Results At T0, 261 patients were assessed, and 229 and 82 patients were retested at T3 and T12, respectively. Patients showed impaired cognitive performance before and after surgery, and although performance improved on the group level, cognitive scores remained significantly lower than in the normative sample up to T12. On the individual level, performance remained stable in the majority of patients. Better preoperative performance, younger age, male sex, and higher educational level predicted better late cognitive performance. Conclusions Meningioma patients face serious and persistent pre- and postsurgical cognitive deficits. A preoperative NPA together with sociodemographic characteristics may provide valuable information on the late cognitive outcome of individual meningioma patients. These results can help to inform patients and clinicians on late cognitive outcomes at an early stage, and emphasizes the importance of presurgical NPA and timely cognitive rehabilitation.


2019 ◽  
Vol 34 (2) ◽  
pp. 229-241 ◽  
Author(s):  
Nadina B Lincoln ◽  
Lucy E Bradshaw ◽  
Cris S Constantinescu ◽  
Florence Day ◽  
Avril ER Drummond ◽  
...  

Objective: To assess the clinical and cost-effectiveness of cognitive rehabilitation for attention and memory problems in people with multiple sclerosis. Design: Multicentre, pragmatic, randomized controlled trial. Setting: Community Participants: People with multiple sclerosis aged 18–69 years, who reported cognitive problems in daily life and had cognitive problems on standardized assessment. Interventions: A group cognitive rehabilitation programme delivered in 10 weekly sessions in comparison with usual care. Main measures: The primary outcome was the Multiple Sclerosis Impact Scale Psychological subscale at 12 months after randomization. Secondary outcomes included measures of everyday memory problems, mood, fatigue, cognitive abilities and employment at 6 and 12 months after randomization. Results: In all, 245 participants were allocated to cognitive rehabilitation and 204 to usual care. Mean Multiple Sclerosis Impact Scale Psychological at 12 months was 22.2 (SD = 6.1) for cognitive rehabilitation and 23.4 (SD = 6.0) for usual care group; adjusted difference −0.6, 95% confidence interval (CI) = −1.5 to 0.3, P = 0.20. No differences were observed in cognitive abilities, fatigue or employment. There were small differences in favour of cognitive rehabilitation for the Multiple Sclerosis Impact Scale Psychological at 6 months and everyday memory and mood at 6 and 12 months. There was no evidence of an effect on costs (−£808; 95% CI = −£2248 to £632) or on quality-adjusted life year gain (0.00; 95% CI = −0.01 to 0.02). Conclusion: This rehabilitation programme had no long-term benefits on the impact of multiple sclerosis on quality of life, but there was some evidence of an effect on everyday memory problems and mood.


2017 ◽  
Vol 32 (2) ◽  
pp. 243-254 ◽  
Author(s):  
Jacqueline R Mhizha-Murira ◽  
Avril Drummond ◽  
Olga A Klein ◽  
Roshan dasNair

Objective: To determine the quantity and quality of description of cognitive rehabilitation for cognitive deficits in people with multiple sclerosis, using a variety of published checklists, and suggest ways of improving the reporting of these interventions. Data sources: A total of 10 electronic databases were searched, including MEDLINE, EMBASE, CINAHL and PsycINFO, from inception to May 2017. Grey literature databases, trial registers, reference lists and author citations were also searched. Review methods: Papers were included if participants were people with multiple sclerosis aged 18 years and over and if the effectiveness of cognitive rehabilitation in improving functional ability for memory, attention or executive dysfunction, with or without a control group, was being evaluated. Results: A total of 54 studies were included in this review. The reporting of a number of key aspects of cognitive rehabilitation was poor. This was particularly in relation to content of interventions (reported completely in 26 of the 54 studies), intervention procedures (reported completely in 16 of the 54 studies), delivery mode (reported completely in 24 of the 54 studies) and intervention mechanism of action (reported completely in 21 of the 54 studies). Conclusion: The quality of reporting of cognitive rehabilitation for memory, attention and executive function for multiple sclerosis, across a range of study designs, is poor. Existing reporting checklists do not adequately cover aspects relevant to cognitive rehabilitation, such as the approaches used to address cognitive deficits. Future checklists could consider these aspects we have identified in this review.


2008 ◽  
Vol 15 (2) ◽  
pp. 266-268 ◽  
Author(s):  
C Montiel-Nava ◽  
JA Peña ◽  
S González-Pernía ◽  
E Mora-La Cruz

Objective To examine the cognitive functioning of children with multiple sclerosis (MS). Methods Six children with a diagnosis of clinically definite MS were evaluated using a neuropsychological test battery. Results The majority of the children showed deficits in at least two of the administered subtests, with IQ scores within the deficient classification. Conclusions Verbal and non-verbal skills were equally impaired, and patients who were older at the moment of the onset of the disease had a better cognitive performance. Cognitive deficits should be regarded as a common occurrence in the course of MS in children.


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