Multimodal Web-Based Intervention for Cancer-Related Cognitive Impairment in Breast Cancer Patients: Cog-Stim Feasibility Study Protocol.
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SUBMITTER: Binarelli G
PROVIDER: S-EPMC8508392 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:INTRODUCTION:Mild cognitive impairment (MCI) is common in older adults and represents a high-risk group for progression to Alzheimer's disease (AD). Medication trials in MCI have generally failed, but new discoveries with brain plasticity in ageing have led to the study of cognitive training as a potential treatment to improve cognitive abilities. Computerised cognitive training (CCT) involves computerised cognitive exercises that target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity. METHODS AND ANALYSIS:In a two-site study (New York State Psychiatric Institute/Columbia University Medical Center and Duke University Medical Center), we will randomise 100 patients with MCI (Wechsler Memory Scale-III Logical Memory II score 0-11; Folstein Mini Mental State Examination ?23) to home-based CCT (suite of exercises: memory, matching, spatial recognition, processing speed) or a home-based active control condition (computerised crossword puzzle training (CPT)) with 12 weeks of intensive training followed by regular booster sessions up to 78 weeks. All patients will receive standard neuropsychological and functional assessments in clinic as well as structural/functional brain MRI scans at study entry and endpoint. We will test if CCT, versus CPT, leads to improved cognitive functioning, transfers to functional ability and tasks of everyday life and impacts hippocampal volume changes and changes in the default mode network of the brain measured by resting-state functional MRI. ETHICS AND DISSEMINATION:The study will be conducted following ethics approval and written informed consent will be obtained from all subjects. Study results will be disseminated via publication, clinicaltrials.gov, media and conference presentations. This will be the first controlled long-term trial to evaluate the effects of home-based CCT versus computerised CPT on cognitive abilities and functional measures and neural outcomes as determined by MRI indices in patients with MCI. Positive results from trial may support further development of home-based CCT. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov identifier (NCT03205709).
| S-EPMC6720324 | biostudies-literature
Project description:Abstract Mild Cognitive Impairment (MCI) is a prevalent pre-dementia state. Emerging evidence supports that physical exercise and computerized cognitive training can independently improve cognitive outcomes. Recently, vitamin D deficiency has been associated with increased risk of progression to dementia. To date, a multimodal intervention based on physical exercises, combined with computerized cognitive training and vitamin D supplementation has not yet been tested in MCI. The SYNERGIC Trial (SYNchronizing Exercises, Remedies in Gait and Cognition) is a multisite clinical-trial aimed to improve cognition and delay progression from MCI to dementia, using the aforementioned multimodal intervention. 200 participants with MCI are being assigned to active or sham interventions. Active interventions (3 days/week) include combined aerobic and progressive resistance training exercise, progressive cognitive training, and vitamin D supplementation (4000 IU/daily) for 6 months. Control interventions consist of balance and toning exercises, control cognitive training, and placebo vitamin D. Primary outcome is improvement in ADAS-Cog 13 (range 0–84; lower scores indicate better cognitive function). ANCOVA adjusting for baseline values was the primary analysis. ClinicalTrials.gov Identifier: NCT02808676. Preliminary results show that combining exercise and cognitive training showed the best improvements on ADAS-Cog 13 after 6 months, followed by combined exercise (combined exercise and cognitive training: 11.67 ± 4.58; combined exercise: 15.29 ± 6.64; balance and toning: 20.77 ± 9.67; p= 0.010). The control group did not improve ADAS-Cog 13 scores. Our preliminary results show that a multimodal intervention with physical and cognitive training is feasible and have a positive effect in improving cognition in MCI.
| S-EPMC6227110 | biostudies-literature
Project description:Dementia affects 35 million people worldwide and is currently incurable. Many cases may be preventable because regular participation in physical, mental and social leisure activities during middle age is associated with up to 47% dementia risk reduction. However, the majority of middle-aged adults are not active enough. MCI is therefore a clear target for activity interventions aimed at reducing dementia risk. An active lifestyle during middle age reduces dementia risk but it remains to be determined if increased activity reduces dementia risk when MCI is already evident. Before this can be investigated conclusively, complex multimodal activity programmes are required that (1) combine multiple health promoting activities, (2) engage people with MCI, and (3) result in sufficient adherence rates.We designed the ThinkingFit programme to engage people with MCI in a complex intervention comprised of three activity components: physical activity, group-based cognitive stimulation (GCST) and individual cognitive stimulation (ICST). Engagement and adherence was promoted by applying specific psychological techniques to enhance behavioural flexibility in an early pre-phase and during the course of the intervention. To pilot the intervention, participants served as their own controls during a 6- to 12-week run-in period, which was followed by 12 weeks of activity intervention.Out of 212 MCI patients screened, 163 were eligible, 70 consented and 67 completed the intervention (mean age 74 years). Activity adherence rates were high: physical activity?=?71%; GCST?=?83%; ICST?=?67%. Significant treatment effects (p?<?.05) were evident on physical health outcomes (decreased BMI and systolic blood pressure, [pre/post values of 26.3/25.9 kg/m2 and 145/136 mmHg respectively]), fitness (decreased resting and recovery heart rate [68/65 bpm and 75/69 bpm]), and cognition (improved working memory [5.3/6.3 items]).We found satisfactory recruitment, retention and engagement rates, coupled with significant treatment effects in elderly MCI patients. It appears feasible to conduct randomized controlled trials of the dementia prevention potential of complex multimodal activity programmes like ThinkingFit.ClinicalTrials.gov registration nr: NCT01603862; date: 17/5/2012.
| S-EPMC4037760 | biostudies-literature
Project description:ObjectivesThe Mini-Cog, a rapid, valid, and reliable screening tool for cognitive impairment, consists of 3-word recall and an executive clock drawing test (CDT). However, CDT requires at least basic literacy and cultural exposure to analog clocks, conditions not met in many population groups around the world. We developed a modification of the Mini-Cog (MMC) for use with nonliterate and literate individuals.MethodsParticipants were adults (≥60 years) with no neurological diagnosis, with known cognitive impairment due to stroke, Parkinsonism, traumatic brain injury, or Alzheimer's disease, and whose family members were able to read and write. We replaced the CDT with two tasks of everyday life: a serial subtraction task or a multistep performance task. Family members rated the acceptability and feasibility of the Mini-Cog versions using a 6-point scale and completed a proxy-rated cognitive staging tool, the Dementia Severity Rating Scale (DSRS). Spearman's rho, Mann-Whitney U, and chi-square tests were used to evaluate group differences and associations between measures.ResultsData were collected from 63 participants (75% ≥ 60 years, 67% nonliterate). Literacy was associated with CDT (chi-square strength 0.9, p < 0.001). Both MMC versions correlated with DSRS in healthy adults and patients (rho 0.6-0.7, p < 0.05). In literate individuals, the acceptability and feasibility of CDT and both alternate distractors were similarly high (5/6).ConclusionsTwo alternate distractor tasks may successfully replace CDT in the Mini-Cog. The MMC versions are promising and deserve further study as screening tools for cognitive impairment in larger and more fully characterized samples.
| S-EPMC8384546 | biostudies-literature
Project description:BackgroundType 2 diabetes mellitus (T2DM) is a risk factor for dementia. Mild cognitive impairment (MCI), an intermediary state between normal cognition and dementia, often occurs during the prodromal diabetic stage, making early diagnosis and intervention of MCI very important. Latest neuroimaging techniques revealed some underlying microstructure alterations for diabetic MCI, from certain aspects. But there still lacks an integrated multimodal MRI system to detect early neuroimaging changes in diabetic MCI patients. Thus, we intended to conduct a diagnostic trial using multimodal MRI techniques to detect early diabetic MCI that is determined by the Montreal Cognitive Assessment (MoCA).MethodsIn this study, healthy controls, prodromal diabetes and diabetes subjects (53 subjects/group) aged 40-60 years will be recruited from the physical examination center of Tangdu Hospital. The neuroimaging and psychometric measurements will be repeated at a 0.5 year-interval for 2.5 years' follow-up. The primary outcome measures are 1) Microstructural and functional alterations revealed with multimodal MRI scans including structure magnetic resonance imaging (sMRI), resting state functional magnetic resonance imaging (rs-fMRI), diffusion kurtosis imaging (DKI), and three-dimensional pseudo-continuous arterial spin labeling (3D-pCASL); 2) Cognition evaluation with MoCA. The second outcome measures are obesity, metabolic characteristics, lifestyle and quality of life.DiscussionThe study will provide evidence for the potential use of multimodal MRI techniques with psychometric evaluation in diagnosing MCI at prodromal diabetic stage so as to help decision making in early intervention and improve the prognosis of T2DM.Trial registrationThis study has been registered to ClinicalTrials.gov ( NCT02420470 ) on April 2, 2015 and published on July 29, 2015.
| S-EPMC4995633 | biostudies-literature
Project description:BackgroundStroke is a leading cause of death and disability worldwide. Despite the prevalence and associated burden of cognitive impairment post-stroke, there is uncertainty regarding optimal cognitive rehabilitation for people post-stroke. This study aimed to assess whether a multicomponent intervention, called OptiCogs, is feasible, acceptable, and safe for people with cognitive impairment post-stroke. A secondary aim was to explore changes in cognitive function, fatigue, quality of life, physical function, and occupational performance, from pre-intervention to post-intervention.MethodsA feasibility study was conducted where people post-stroke with cognitive impairment enrolled in a 6-week multicomponent intervention. The primary outcomes recorded included response rate, recruitment rate, retention rate, adherence to the intervention protocol, adverse events, and acceptability of the intervention to people post-stroke. Secondary outcomes included (i) change in cognitive functioning using the Addenbrooke's Cognitive Examination III, (ii) fatigue using the Fatigue Severity scale, (iii) quality of life using the Stroke Specific Quality of Life scale (iv) physical function using the patient-reported outcomes measurement information system, and (v) patient-reported occupational performance using the Canadian Occupational Performance Measure. The Consolidated Standards of Reporting Trials extension reporting guidelines were followed, for pilot and feasibility studies, to standardize the conduct and reporting of this study.ResultsThe response rate was 10.9%. Nine eligible participants were enrolled during the 4-month recruitment period, with eight participants completing the entire 6-week intervention, as well as the pre- and post-intervention outcome measures. There were no reported adverse events. Participants were satisfied with the intervention and found it acceptable overall. Results of the secondary outcomes were promising for cognitive function (ACE III, pre: 63.3 ± 23.9 to post: 69 ± 24.6), fatigue (FSS, pre: 52.5 ± 7.3 to post: 45.6 ± 7.2), quality of life (SSQoL, pre: 131.0 ± 26.3 to post: 169.9 ± 15.3), physical function (PROMIS-PF, pre: 15.5 ± 6.3 to post: 15.8 ± 5.3), and occupational performance (COPM performance, pre: 9.3 ± 2.3 to post: 22.9 ± 4.2) and COPM satisfaction, pre: 9.9 ± 2.1 to post: 22.7 ± 3.5).ConclusionPreliminary results suggest low-modest recruitment and high retention rates for the OptiCogs intervention. Changes in cognitive function, fatigue, quality of life, and self-reported occupational performance show improvement from pre- to post-intervention. These potential benefits require further testing in a larger pilot trial.Trial registrationNCT05414539.
| S-EPMC10583340 | biostudies-literature
Project description:BackgroundVascular cognitive impairment, no dementia (VCIND) refers to cognitive deficits associated with underlying vascular causes that fall short of a dementia diagnosis. There is currently no treatment for VCIND. Computerized cognitive training, which has significantly improved cognitive function in healthy older adults and patients with cognitive impairment has not yet been applied to VCIND.Methods/designThe proposed study is a three-center, double-blinded, randomized controlled trial that will include 60 patients with VCIND. The patients will be randomized to either a training or a control group. The intervention is internet-based cognitive training performed for 30 min over 35 sessions. Neuropsychological assessment and functional and structural MRI will be performed before and after 7 weeks training. Primary outcomes are global cognitive function and executive function. Secondary outcome measures are neuroplasticity changes measured by functional and structural MRI.DiscussionApplying an internet-based, multi-domain, adaptive program, this study aims to assess whether cognitive training improves cognitive abilities and neural plasticity in patients with subcortical VCIND. In addition to the comprehensive assessment of the participants by neuropsychological tests, cerebrovascular risk factors and apolipoprotein E genotyping, neuroplasticity will be used as an evaluation outcome in this study for, to our knowledge, the first time. The combination of functional and structural MRI and neuropsychological tests will have strong sensitivity in evaluating the effects of cognitive training and will also reveal the underlying mechanisms at work.Trial registrationClinicalTrials.gov NCT02640716 . Retrospectively registered on 21 December 2015.
| S-EPMC4974771 | biostudies-literature
Project description:IntroductionCancer-related cognitive impairment (CRCI) is a distressing and disabling side-effect of cancer treatments affecting up to 75% of patients. For some patients, their cognitive impairment may be transient, but for a subgroup, these symptoms can be long-standing and have a major impact on the quality of life. This paper describes the protocol for a study: (1) to assess the feasibility of collecting longitudinal data on cognition via self-report, neuropsychological testing, peripheral markers of inflammation and neuroimaging and (2) to explore and describe patterns of cancer-related cognitive impairment over the course of treatment and recovery in patients with newly diagnosed, aggressive lymphoma undergoing standard therapy with curative intent.Methods and analysisThis is a prospective, longitudinal, feasibility study in which 30 newly diagnosed, treatment-naive patients with aggressive lymphoma will be recruited over a 12-month period. Patients will complete comprehensive assessments at three time points: baseline (time 1, pre-treatment) and two post-baseline follow-up assessments (time 2, mid-treatment and time 3, 6-8 weeks post-treatment completion). All patients will be assessed for self-reported cognitive difficulties and objective cognitive function using Stroop Colour and Word, Trail Making Test Part A and B, Hopkins Verbal Learning Test-Revised, Controlled Oral Word Association and Digit Span. Blood cell-based inflammatory markers and neuroimaging including a positron emission tomography (PET) with 18F-labelled fluoro-2-deoxyglucose (18F-FDG) and CT (18F-FDG-PET/CT) and a MRI will explore potential inflammatory and neuroanatomical or functional mechanisms and biomarkers related to CRCI. The primary intent of analysis will be to assess the feasibility of collecting longitudinal data on cognition using subjective reports and objective tasks from patients during treatment and recovery for lymphoma. These data will inform the design of a larger-scale investigation into the patterns of cognitive change over the course of treatment and recovery, adding to an underexplored area of cancer survivorship research.Ethics and disseminationEthical approval has been granted by Austin Health Human Rights Ethics Committee (HREC) in Victoria Australia. Peer reviewed publications and conference presentations will report the findings of this novel study.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12619001649101).
| S-EPMC7526311 | biostudies-literature
Project description:BACKGROUND:Apolipoprotein E (APOE) ?4 allele is a major genetic risk factor for Alzheimer disease and mild cognitive impairment (MCI). Computer-based training programs can improve cognitive performance in elderly populations. However, the effects of computer-based interventions on MCI APOE ?4 carriers have never been studied before. OBJECTIVE:The effects of different web-based interventions and the APOE isoform-specific differences in training outcomes are investigated. METHODS:Using a quasi-experimental study design, 202 participants with MCI aged 60 years and older took part in three different intervention programs (physical and cognitive [Long-Lasting Memories, or LLM], cognitive [Active Control, or AC], or physical intervention [Physical Training Control, or PTC]) via an innovative information and communication technologies exergaming platform. Participants in each interventional group were subdivided into APOE ?4 carriers and non-APOE ?4 carriers. All participants underwent an extensive neuropsychological evaluation before and after the training, blood tests, and brain imaging. RESULTS:All interventions resulted in multiple statistically significant cognitive benefits after the intervention. Verbal learning (California Verbal Learning Test: immediate recall test score-LLM: P=.04; AC: P<.001), working memory (digit span forward and backward test scores-AC: P=.03; PTC: P=.02 and P=.006, respectively), and long-term memory (California Verbal Learning Test: delayed recall test score-LLM: P=.02; AC: P=.002; and PTC: P=.02) were improved. There was no statistically significant difference among the intervention effects. APOE ?4 presence moderates intervention effects as the LLM intervention improved only their task-switching processing speed (Trail Making Test, Part B: P=.03) and the PTC intervention improved only the working memory (digit span backward: P=.03). No significant performance alteration was noted for the APOE ?4+ cognitive AC training group. CONCLUSIONS:None of the applied interventions could be identified as the optimal one; it is suggested, however, that combined cognitive and physical training and physical training via exergaming may be more effective for the high-risk MCI ?POE ?4+ subgroup.
| S-EPMC7243129 | biostudies-literature
Project description:IntroductionThe diagnosis of mild cognitive impairment (MCI), that is, the transitory phase between normal age-related cognitive decline and dementia, remains a challenging task. It was observed that a multimodal approach (simultaneous analysis of several complementary modalities) can improve the classification accuracy. We will combine three noninvasive measurement modalities: functional near-infrared spectroscopy (fNIRS), electroencephalography and heart rate variability via ECG. Our aim is to explore neurophysiological correlates of cognitive performance and whether our multimodal approach can aid in early identification of individuals with MCI.Methods and analysisThis study will be a cross-sectional with patients with MCI and healthy controls (HC). The neurophysiological signals will be measured during rest and while performing cognitive tasks: (1) Stroop, (2) N-back and (3) verbal fluency test (VFT). Main aims of statistical analysis are to (1) determine the differences in neurophysiological responses of HC and MCI, (2) investigate relationships between measures of cognitive performance and neurophysiological responses and (3) investigate whether the classification accuracy can be improved by using our multimodal approach. To meet these targets, statistical analysis will include machine learning approaches.This is, to the best of our knowledge, the first study that applies simultaneously these three modalities in MCI and HC. We hypothesise that the multimodal approach improves the classification accuracy between HC and MCI as compared with a unimodal approach. If our hypothesis is verified, this study paves the way for additional research on multimodal approaches for dementia research and fosters the exploration of new biomarkers for an early detection of nonphysiological age-related cognitive decline.Ethics and disseminationEthics approval was obtained from the local Ethics Committee (reference: 83/19). Data will be shared with the scientific community no more than 1 year following completion of study and data assembly.Trial registration numberClinicalTrials.gov, NCT04427436, registered on 10 June 2020, https://clinicaltrials.gov/ct2/show/study/NCT04427436.
| S-EPMC8154928 | biostudies-literature