Propranolol reduced resting tremor both with and without a cognitive stressor, but levodopa remains the primary treatment for PD tremor.
Risultati per: Gestione delle complicanze psichiatriche e cognitive nel Parkinson
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APPROACH: Analysis of Proton versus Photon Radiotherapy in Oligodendroglioma and Assessment of Cognitive Health – study protocol paper for a phase III multicentre, open-label randomised controlled trial
Introduction
Oligodendroglioma (ODG) is a rare type of brain tumour, typically diagnosed in younger adults and associated with prolonged survival following treatment. The current standard of care is maximal safe debulking surgery, radiotherapy (RT) and adjuvant procarbazine, lomustine and vincristine (PCV) chemotherapy. Patients may experience long-term treatment-related toxicities, with RT linked to impairments of neurocognitive function (NCF) and health-related quality of life (HRQoL). With proton beam therapy (PBT), radiation dose falls off sharply beyond the target with reduced normal brain tissue radiation doses compared with photon RT. Therefore, PBT might result in reduced radiation-induced toxicity compared with photon RT.
Methods and analysis
APPROACH is a multicentre open-label phase III randomised controlled trial of PBT versus photon RT in patients with ODG, investigating the impact of PBT on long-term NCF measured using the European Organisation for Research and Treatment of Cancer (EORTC) Core Clinical Trial Battery Composite (CTB COMP). The trial will randomise 246 participants from 18 to 25 UK RT sites, allocated 1:1 to receive PBT or photon RT, with PBT delivered at one of the two UK PBT centres. Participants with grade 2 and grade 3 ODG will receive 54 Gy in 30 fractions and 59.4 Gy in 33 fractions, respectively, followed by 6×6-weekly cycles of PCV chemotherapy. The trial contains staged analyses, with an internal pilot for feasibility of recruitment at 12 months, early assessment of efficacy at 2 years, futility assessment and final primary endpoint comparison of NCF between arms at 5 years. Secondary endpoints include additional NCF, treatment compliance, acute and late toxicities, endocrinopathies, HRQoL, tumour response, progression-free survival and overall survival.
Ethics and dissemination
Ethical approval was obtained from Newcastle North Tyneside REC (reference 22/NE/0232). Final trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors (ICMJE) guidelines.
Trial registration number
ISRCTN:13390479.
Narrative enhancement and cognitive therapy for self-stigma among youth with bipolar disorder or multiple mental health conditions: protocol for a pilot randomised basket trial
Introduction
Self-stigma occurs when individuals internalise negative stereotypes about their mental health conditions. Self-stigma is common among those with serious mental illnesses, including youth, and is considered a major barrier to recovery through its impact on hope, self-esteem and self-identity. This patient-oriented protocol aims to assess the feasibility of conducting a future full-scale randomised controlled trial (RCT) of a youth-oriented adaptation of narrative enhancement and cognitive therapy for self-stigma among youth (NECT-Y).
Methods and analysis
This is a two-site, two-arm pilot basket RCT with 1:1 randomisation to NECT-Y or treatment as usual (TAU). Participants are youth, ages 16–29 diagnosed with bipolar disorder, any subtype (Basket 1) or with any two or more mental health conditions (Basket 2). After informed consent, we will conduct baseline assessments and randomisation, then either a 14-week NECT-Y group intervention or TAU. Diagnostic interviews will be used to confirm diagnosis at baseline. A range of self-report questionnaires will be administered at baseline, post-treatment and 3 month follow-up. The primary outcome is feasibility as indicated by the achievement of recruitment goals, retention and adherence, intervention fidelity and the absence of serious adverse events. Secondary outcomes include acceptability and the intervention’s impact on self-stigma, wellness, symptomatology, treatment-seeking attitudes and other related constructs. A youth advisory group is informing all stages of the study process.
Ethics and dissemination
The Research Ethics Board for Centre for Addiction and Mental Health (#062/2024) has approved this study protocol. Ethics is also approved at London Health Sciences Centre (Western Health Sciences Research Ethics Board (HSREB) #125812). Results will be published in international peer-reviewed journals and presented at relevant conferences. Summaries will be provided to the funders of the study, as well as to lay audiences, including study participants.
Trial registration number
NCT06672562.
Cognitive Behavioral Therapy Approach May Improve Long COVID Symptoms, Boost Physical Function
Rehabilitation involving cognitive behavioral therapy could help improve functional capacity for those with post–COVID-19 condition, also known as long COVID, according to a randomized clinical trial published in JAMA Network Open. Patients who had undergone a brief outpatient program incorporating cognitive and behavioral approaches reported greater improvements in physical function after 1 year than those who had undergone rehabilitation care as usual.
[Articles] Cerebral blood flow and cognitive functioning in patients undergoing transcatheter aortic valve implantation
In patients with severe symptomatic aortic valve stenosis undergoing TAVI, cardiac output, CBF, and cognitive functioning improved after three months.
More Evidence of Ongoing Cognitive Deficits After COVID-19
Objective brain injury and associated cognitive impairment were noted as long as 1 year after infection with SARS-CoV-2.
Cognitive behavioural therapy plus Kiesler Circle Training (CBT+) versus CBT only for patients with interpersonal problems: study protocol for a randomised controlled feasibility trial
Introduction
Interpersonal problems are a transdiagnostic risk factor for the development and maintenance of various psychiatric disorders, including anxiety and depression. Interventions that address these interpersonal challenges could therefore play a crucial role in enhancing mental health. This study aims to evaluate the efficacy and feasibility of a transdiagnostic group intervention, the Kiesler Circle Training (KCT), in improving interpersonal skills.
Methods and analysis
In a prospective randomised controlled trial (RCT), 156 outpatients with a primary diagnosis of either depression or anxiety disorder according to DSM-5, and significant interpersonal problems, will be investigated. All patients will receive individual, state-of-the-art cognitive behavioural therapy (CBT) during the study. They will be randomly assigned to one of two conditions: the experimental group will receive the KCT in group sessions, in addition to individual CBT, while the control group will receive only individual CBT. The KCT intervention consists of 1 introductory individual session and 12 weekly group sessions, each lasting 100 min, with groups of up to 10 patients. KCT includes five sequential modules: the interpersonal circle, nonverbal communication, verbal communication, conflict resolution and empathy training. It is hypothesised that the experimental group will show (a) greater reduction in interpersonal problems from pre-assessment to post-assessment and (b) greater symptomatic improvement regarding the primary diagnosis. Child maltreatment is expected to moderate the trajectory of interpersonal problems. This study aims to provide evidence for the feasibility of KCT as a modular transdiagnostic add-on approach for patients with interpersonal difficulties.
Ethics and dissemination
This study obtained approval from the ethics committees at the Charité Berlin, the Medical School of Berlin and the University of Greifswald. All results will be disseminated through peer-reviewed articles in scientific journals and contributions to national and international conferences.
Trial registration number
DRKS00032467, NCT06170801 (see Supplementary Material).
Gestione farmacologica degli adulti con dislipidemia: linee guida
Letter by Tunçez and Gürses Regarding Article, “Effect of Sacubitril/Valsartan on Cognitive Function in Patients With Heart Failure With Preserved Ejection Fraction: A Prespecified Analysis of PARAGON-HF”
Circulation, Volume 151, Issue 6, Page e37-e37, February 11, 2025.
Response by Shen et al to Letter Regarding Article, “Effect of Sacubitril/Valsartan on Cognitive Function in Patients With Heart Failure With Preserved Ejection Fraction: A Prespecified Analysis of PARAGON-HF”
Circulation, Volume 151, Issue 6, Page e38-e38, February 11, 2025.
Alzheimer, un farmaco sperimentale ripristina la memoria e le altre funzioni cognitive
Exploring how PRIME-Parkinson care is implemented and whether, how and why it produces change, for who and under what conditions: a protocol for an embedded process evaluation within the PRIME-UK randomised controlled trial
Introduction
The PRIME-UK randomised controlled trial (RCT) aims to establish whether a model of care that seeks to be proactive, integrated and empower participants, caregivers and healthcare professionals can improve outcomes in people with parkinsonism. Given that this intervention is novel and complex, understanding whether and how the intervention will be acceptable, implementable, cost-effective and scalable across contexts are key questions beyond that of whether ‘it works’. We describe an embedded process evaluation to answer these questions, which aims to support interpretation of the trial results, refinement of the intervention and support future scaling of the PRIME-Parkinson model of care.
Methods and analysis
A mixed-methods approach will be used to collect data across four process evaluation domains: implementation, mechanism of change, acceptability and context. Quantitative data will be collected prospectively from all participants and analysed descriptively with exploratory tests of relationships as power allows. Qualitative data will be collected through semistructured interviews with a purposively sampled subpopulation of participants, caregivers and staff members as well as case studies where relevant. Interview transcripts will be analysed thematically using interpretive qualitative analysis. Synthesis of quantitative and qualitative data will also be performed to draw conclusions.
Ethics and dissemination
The quantitative data will be collected as part of the main PRIME-UK RCT which was been granted NHS REC approval (21/LO/0387) on 27 July 2021. The qualitative data will be collected as part of a substudy, ‘PRIME-Qual’, which was granted NHS REC approval (21/LO/0388) on 14 July 2021. The mixed-methods process evaluation will be published after the conclusion of the trial in addition to the main trial findings.
Trial registration number
NCT05127057.
Self-Guided vs Clinician-Guided Online Cognitive Behavioral Therapy for Atopic Dermatitis
This randomized clinical noninferiority trial investigates whether a brief online self-guided cognitive behavioral therapy intervention is noninferior to a comprehensive online clinician-guided cognitive behavioral therapy treatment.
Grief-Specific Cognitive Behavioral Therapy vs Present-Centered Therapy
This randomized clinical trial investigates the effectiveness of integrative cognitive behavioral therapy vs present-centered therapy in patients with prolonged grief disorder.
Abstract 92: Blocking the VCAM1-VLA4 axis prevents cognitive decline in a mouse model of infarct-induced neurodegeneration
Stroke, Volume 56, Issue Suppl_1, Page A92-A92, February 1, 2025. Introduction:Infarct-induced neurodegeneration occurs chronically after stroke and can be prevented by inhibiting B cell influx to the brain. Vascular cell adhesion molecule 1 (VCAM1) facilitates immune cell diapedesis by binding very late antigen 4 (VLA4), and VCAM1 plasma levels are elevated after stroke in people and mice. We hypothesized that chronic treatment with anti-VCAM1 or anti-VLA4 would reduce lymphocyte trafficking and prevent cognitive decline.Methods:Adult (3 month old) and middle-aged (10 month old) C57BL/6J male&female mice (N=9-10/group) underwent permanent middle cerebral artery occlusion and were dosed with anti-VCAM1, anti-VLA4 or control IgG every 3 days beginning 4 days after stroke. Sham mice received IgG only. Barnes maze and novel object were performed at -1, 1 and 6 weeks, and single-cell RNA sequencing was performed on immune and endothelial cells at 10 weeks. We quantified pericyte (CD13) vascular (CD31) coverage and extravascular fibrinogen leakage with immunostaining.Results:Blocking either VCAM1 or VLA4 reduced B cells 67% or 55%, respectively, compared to IgG treated stroked mice three weeks after stroke. Stroked mice treated with IgG developed a cognitive deficit in both Barnes maze and novel object by 6 weeks, while both anti-VCAM1 and anti-VLA4 treated mice performed comparably to sham animals in the Barnes maze (p=0.398; p=0.972, respectively). Similarly, sham IgG (p
Abstract 97: Association of Post-Stroke Cognitive Impairment with Impaired Glymphatic Function and Neurotoxin Waste Removal in Patients with Intracerebral Hemorrhage
Stroke, Volume 56, Issue Suppl_1, Page A97-A97, February 1, 2025. Objective:To evaluate a potential relationship between post-stroke cognitive impairment (PSCI) and a radiographic measure of glymphatic function after intracerebral hemorrhage (ICH).Introduction:PSCI has been less studied in patients with ICH. Here we aim to evaluate the role of glymphatic function after ICH and its association with PSCI. Glymphatic cleanup occurs in the perivascular space (PVS) formed by astroglial end-feet loosely surrounding small arteries and veins. Here we applied non-invasive diffusion tensor imaging (DTI) to measure changes in brain diffusion due to dynamics changes of interstitial fluid (ISF) and CSF along the PVS. The application of DTI-along the perivascular space index (DTI-ALPSI) has been validated to evaluate glymphatic function. It computes the diffusivity ratio between projection and association fibers oriented orthogonally with the medullary veins at the level of the lateral ventricle body (Fig-1A).Methods:We serially imaged 18 patients with deep ICH at 9.3±9.1 (V1) and 109±28 (V2) days of onset on a 3T MRI system. Cognitive assessment was obtained via MoCA scores. Fractional anisotropy (FA) and mean diffusivity (MD) maps were registered to the T1W and SWI images. Three regions of interest (ROI), remote from a lesion, in the association and projection fibers, orthogonal to the medullary veins at PVS were used to compute diffusivity (Fig-1C). Using the equation shown, the DTI-ALPSI was calculated. DTI-ALPSI = Mean (Dx proj, Dx assoc) / Mean (Dy proj, Dz assoc)Using 3D-Flair images, hematoma (HV) and edema (EV) volumes were segmented. The ipsilesional DTI-ALPSI was correlated with MoCA, HV, and NIHSS. Contralesional DTI-ALPSI was used as a control. A non-linear regression model was used for statistical analysis.Results:We enrolled 12M/6F with an average age of 49.3±13.3y. Compared to the control, the ipsilesional DTI-ALPSI was significantly decreased (p=0.036) at V2. Temporally the MoCA scores were significantly increased (19±8.5 to 23±6.0, p