Clinical Research Directory

MEOP - Multidimensional Evaluations in Oncological Psychiatry

Cancer is among the leading causes of morbidity and mortality worldwide, profoundly affecting patients' lives at every level, and its psychological and psychiatric impacts remain a major concern. Psychiatric disorders are frequently observed in cancer patients. Nevertheless, they were also underdiagnosed, with a consequent undermining possible interventions. Still, psychiatric disorders in cancer patients are not merely secondary complications but may actively contribute to poor oncological outcomes. The pathophysiology of cancer-related psychiatric disorders is multifactorial and is related to several neuropsychological and neurobiological factors. Specifically, the production of cytokines associated with cancer appears to play a role in the development of depression. Tumours trigger an inflammatory response that leads to the release of pro-inflammatory cytokines. These cytokines influence central nervous system function and disrupt the regulation of the HPA axis, contributing to psychological symptoms such as depression, fatigue, sleep disturbances, and appetite loss. Moreover, psychiatric symptoms in cancer patients are often accompanied by neuropsychological alterations including deficits in memory, executive function, and attention. Compared to other individuals with psychiatric disorders, cancer patients may experience more severe cognitive impairments which can be exacerbated by cancer treatments, including surgery, chemotherapy, and radiotherapy. These treatments stimulate cytokine production by nearby non-cancerous cells and immune cells activated in response to treatment-induced cell death, thereby driving systemic inflammation. Cancer profoundly affects not only patients but also their families, who often bear the emotional and caregiving burden. Being close to a loved one with cancer can lead to significant psychological distress, including anxiety and depression, among family members and caregivers. The ripple effects of this burden underscore the need for a holistic approach to mental health in oncology. Given the background presented so far, identifying and managing psychiatric comorbidities in oncological patients and their families is crucial. This multifaceted interplay between cancer and psychiatric disorders necessitates a comprehensive, interdisciplinary approach to understanding, diagnosing, and treating these conditions effectively.

Nutrition-based Interventions to Prevent Cognitive Decline

This study intends to evaluate the feasibility and the effectiveness of an innovative and integrated nutrition-based intervention addressing key modifiable risk factors for dementia while meeting participants' preferences for nutrition-related sessions. The intervention will include lifestyle group sessions regarding nutrition education and physical activity, individualized cognitive training at home, as well as clinical nutrition consultations.

Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is widely assumed that cognition returns to baseline after anesthetics have been eliminated. However, many patients have persistent memory impairment for weeks to months after surgery. Cardiac surgery appears to carry the highest risk of postoperative cognitive dysfunction (POCD). These cognitive deficits are associated with increased mortality, prolonged hospital stay and loss of independence. The investigators propose to investigate the role of Dexmedetomidine (DEX) in preventing long-term POCD after cardiac surgery and enhancing early postoperative recovery. It is anticipated that DEX will be the first effective preventative therapy for POCD, improve patient outcomes, and reduce length of stay and healthcare costs.

Polyamine Treatment in Elderly Patients With Coronary Artery Disease

The present study is testing spermidine treatment in elderly patients with coronary artery disease. The study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group, single centre, clinical study.

Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery

The goal of this clinical trial (Balanced-2 study) is to compare light to deep general anesthesia using widely available brain monitors, to see if 'light' anesthesia could reduce rates of delirium, cognitive decline, and disability in older adults undergoing major surgery. Delirium is the most common serious surgical complication, occurring in an estimated one in four older adults undergoing major surgery. Delirium causes significant distress to patients and family, and is associated with prolonged hospital stay, physical disability, progression to dementia-like illnesses, and discharge to long-term care. Between 10 - 30% of adults aged 70 years and above have surgery every year, and preserving brain health and wellbeing is an important priority during this time. Older adults (aged ≥65 years, or Indigenous, Pacific patients aged ≥55 years) undergoing major surgery with general anesthesia (excluding heart and brain surgery) and able to provide consent will be able to participate. Participants will be randomized to two groups - a lighter general anesthesia group and a deeper general anesthesia group using processed electroencephalography (a brain monitor that provides information on depth of anesthesia using brain waves). The anesthesiologist will titrate anesthetic drugs according to the brain monitor. Participants will be followed up to determine if they experience delirium after surgery, and longer term impact of delirium such as cognitive and physical decline will also be measured. If found to be effect, this simple, cheap, and widely available treatment could reduce disability, preserve brain health and wellbeing of many older adults undergoing surgery worldwide, and save millions in healthcare dollars.

Interventions in Mathematics and Cognitive Skills

The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).

DIAMOND-Lewy Guidelines for Antipsychotic Use in Older Patients

The goal of this observational study is to learn about current practices for the acute neuropsychiatric management of older adults during emergency department (ED) visits. Researchers will compare current standard of care practices with implemented guideline practice to see if standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations. The main questions this study aims to answer are: * How many older adults are receiving antipsychotics or benzodiazepines during emergency department visits? * Why are older adults receiving antipsychotics or benzodiazepines during emergency department visits? * How many older adults who receive antipsychotics or benzodiazepines during emergency department visits have an underlying cognitive or movement disorder? * What effects does administration of antipsychotics or benzodiazepines during emergency department visits have on patient outcomes in older adults and adults with neurocognitive disorders? * Does implementation of standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations?

VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical

VIRGIL is a monocentric interventional study aiming to investigate the effect of immersion in a virtual tilted room on modulation of the verticality representation (postural vertical \[PV\] and visual vertical \[VV\]), which in turn might affect body orientation (head and trunk). To this end, the investigators will conduct a within-person randomized trial including post-stroke patients and healthy participants.

The Impact TDCS-linked Motor and Cognitive Training Gains in Parkinson's Disease

This study is a group controlled clinical trial. Parallel study, patients aged 40-70 years, with Parkinson disease. Twelve sessions, three times a week, for 30 minutes, simultaneously to the rehabilitation program. Training will consist of Transcranial Direct Current Stimulation linked dual-task exercises or dual-taks exercises with cognitive training, applied three times a week during four weeks. The investigators will used instruments: dual-task gait speed (Auditory Stroop Task ), executive function (Wisconsin Card Sorting Test , Auditory Stroop Test, Trail Making Test, Verbal Fluency Test and Montreal Cognitive Assessment), and, the objective is to examine task-dependency in enhancing the effects of tDCS-linked rehabilitation training on PD and the relationships between baseline outcomes in responders and non-responders to therapy.

The Trajectory and Influencing Factors of Cognitive Level in ICU Delirium Patients After Transfer Out of the ICU

Introduction：Delirium is a prevalent psychiatric disorder observed in the Intensive Care unit(ICU) hat; often aggravates patients; overall health status, extends the duration of mechanical ventilation, prolongs ICU stays, and causes persistent or long-term cognitive impairment. A plethora of studies have indicated that the frequency, duration, and severity of delirium during hospitalization are significant risk factors for cognitive impairment in patients following transfer from the ICU. However, existing research has predominantly focused on cross-sectional analyses without delving into the influencing factors among patient subgroups. Consequently, the aim of this study is to employ the Latent Growth Curve Model (LGCM) and the Latent Class Growth Model (LCGM) model to analyze the trajectory of cognitive development and influencing factors of patients with delirium in the ICU one year after discharge. Methods and analysis：This prospective study aims to investigate the trajectory of cognitive level variations of patients with delirium in ICU for one year. It is planned to recruit 240 participants and gather comprehensive data including general demographics, disease-related information, scores from the Minimum Mental State Examination, Hospital Anxiety and Depression Scale, and the Pittsburgh Sleep Quality Index. All data will be followed up using the same schedule on the day of transfer, 1 month after transfer, 3 months after transfer, 6 months after transfer and 1 year after transfer. Ultimately, the investigators will employ Latent Growth Curve Model and Latent Class Growth Model to analyze the trajectory of cognitive changes and identify potential categories, in addition to utilizing logistic regression modeling to explore influencing factors. The results of this study provide a theoretical framework for the clinical implementation of precision nursing interventions within this demographic, so as to prevent and reduce the decline of cognitive function and improve the quality of life of patients.

Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints

Many post COVID-19 patients suffer from cognitive deficits, even after 1 year after hospitalization. These complaints have a huge impact on psychological well-being and quality of life. In rehabilitation programs in the Netherlands, most interventions are based on physical therapy or learning how to cope with fatigue and low levels of energy. In former studies computerized training of cognition in other populations has been proven to be effective. Knowledge on the effect of computerized training on attention and working memory in patients suffering from COVID-19 is urgently needed, and may contribute to more evidence-based rehabilitation programs for these patients. Therefore the effectiveness of computerized training of attention and working memory in post COVID-19 patients with cognitive complaints will be studied in this study.

Human Epilepsy Genetics--Neuronal Migration Disorders Study

The purpose of this study is to identify genes responsible for epilepsy, brain malformations and disorders of human cognition.

Cognitive Exercises in Survivors of a Prolonged ICU Stay.

This study concerns patients who survived intensive care, after a minimum stay of 7 days and presenting cognitive disorders (with a score ≤ 26 on the MoCA test) during the post-intensive care follow-up consultation one month after ICU discharge. The objective of this prospective open-label randomized study is to assess the impact of cognitive stimulation on recovery from cognitive impairment after a critical illness.

A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China

A study conducted in Finland discovered that a multidomain intervention, consisting of physical activity, nutritional guidance, cognitive training, social activities, and management of vascular risk factors, effectively decelerated cognitive decline in healthy older adults who were at an increased risk of cognitive decline. The HERITAGE study is a 2-year clustered randomized controlled trial (clustered-RCT) that explores the efficacy of a multidomain intervention among 1200 elderly residents with a higher risk of cognitive decline and dementia in Zhejiang Province, China