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NCT07422740
This study investigates whether combining virtual reality mindfulness-based cognitive therapy (VR-MBCT) with transcranial direct current stimulation (tDCS) can effectively treat depression occurring after a stroke (post-stroke depression, PSD). The goal is to determine if this combined approach is more beneficial than either treatment alone or standard care in alleviating depressive symptoms. The study will enroll adults aged 18-65 who have experienced a stroke within the past week, are medically stable, and exhibit moderate to severe depression symptoms. Participants must be right-handed and able to undergo MRI scans and study assessments. Individuals with certain neurological or psychiatric conditions, other major health issues, or specific contraindications for tDCS will not be eligible. Procedures: This is a randomized controlled trial lasting approximately 28 weeks, divided into two phases. In the first phase (8 weeks), participants are randomly assigned to one of four groups: Group 1: Receives sham (placebo) versions of both VR-MBCT and tDCS plus standard medication. Group 2: Receives active tDCS and sham VR-MBCT plus standard medication. Group 3: Receives active VR-MBCT and sham tDCS plus standard medication. Group 4: Receives both active VR-MBCT and active tDCS plus standard medication. Treatments are administered 5-6 times per week for 4 weeks, followed by a 4-week blinded follow-up.The primary outcome is the change in depression scores (HDRS-24、PHQ-9) from baseline to 8 weeks. Secondary outcomes include rates of clinical response, remission, relapse, treatment acceptability, and changes in anxiety, sleep quality, and daily functioning.
NCT07294274
Post-stroke depression (PSD) is the most common neuropsychiatric disorder after a stroke, with an incidence rate of 20% to 60%. PSD is not only associated with higher mortality rates, poorer recovery, more obvious cognitive impairments, greater economic burdens, and lower quality of life, but also brings additional medical expenses and care pressure to families. Society also needs to bear higher medical costs. Currently, the early diagnosis of PSD is difficult, which may lead to poor prognosis after stroke. This study aims to utilize machine learning technology to integrate multi-dimensional indicators of patients with ischemic stroke, establish a risk prediction model for PSD, and assist in early, accurate, and individualized assessment of PSD risk in clinical practice.
NCT07343284
This study is titled "Effect of a Nursing Intervention Based on Health Education on Functionality, Depression Symptoms, and Quality of Life in Patients with Ischemic Stroke." It is a quasi-experimental, longitudinal, prospective clinical trial that will beconducted with patients who have suffered an ischemic stroke and were treated in the neurology unit of the Lucus Augusti University Hospital, the same center where this study will take place. The primary objective of the study is to determine the effect of a nursing intervention based on health education on quality of life and depression symptoms in individuals who have experienced an ischemic stroke. To achieve this objective, variables such as cognitive status, depression symptoms, autonomy and ability to perform basic activities of daily living, neurological deficits, and quality of life will be assessed. Regarding the total number of subjects to be studied, according to the Stroke Atlas in Galicia published by the Spanish Society of Neurology in 2018, the autonomous community of Galicia had a population of 2,701,819 inhabitants. Applying an incidence rate of 187.4 cases per 100,000 inhabitants according to the IBERICTUS study, an estimated 5,064 new stroke cases occur each year in Galicia. The province of Lugo had 324,842 inhabitants as of January 1, 2024, according to the INE; therefore, applying the same incidence rate, an estimated 609 new stroke cases occur per year. Considering the proportion of ischemic strokes compared to other types of strokes (80:20), the estimated number of ischemic stroke cases in Lugo would be 487. The representative sample size of stroke patients in the province of Lugo would be 70 patients, with 35 patients receiving the intervention and 35 serving as controls. Independent Variables: Sociodemographic: sex, age, event date. Clinical: stroke type, treatment modality (rt-PA or thrombectomy), falls, pain, pressure ulcers, aspiration, pneumonia, dysphagia, vital signs. Health education: received vs. not received. Dependent Variables: Cognitive status (MMSE). Depression symptoms (BDI). Autonomy and ADL performance (Barthel Index). Neurological deficits (NIHSS). Quality of life (European Quality of Life Scale). Instruments Mini-Mental State Examination (MMSE) Beck Depression Inventory (BDI) Barthel Index NIH Stroke Scale (NIHSS) Visual Analogue Scale (VAS) European Quality of Life Scale (EQLS)
NCT06899893
The project team will categorize stroke patients into three groups receiving iTBS stimulation targeting distinct brain regions: the cerebellum, the dorsolateral prefrontal cortex (DLPFC), and the primary motor cortex (M1), with 20 patients allocated to each group. Neurofunctional scores, anxiety and depression assessments, and transcranial magnetic stimulation evoked potentials (TEP) will be assessed pre- and post-treatment within each group. The relationship between anxiety and depression scores and brain network characteristics associated with emotions will be examined to investigate the impact of iTBS stimulation on post-stroke negative emotions. Furthermore, plasma and saliva samples will be collected from stroke patients in each group post iTBS intervention. ELISA will quantify ACTH levels in plasma and cortisol levels in both plasma and saliva, with the aim of exploring the effects of iTBS stimulation on the HPA axis across different brain regions.
NCT06598670
The aim of the research is to address the critical gap that limited number of RCTs are conducted on this topic. To further explore the efficacy of tDCs, large sample sizes, large follow up period and rigorously controlled randomized clinical trials are necessary. An optimum stimulation protocol is also needed on this study. Previous studies lack information regarding effects of this stimulation on depression, cognition, quality of life in relation to different severity levels of stroke.
NCT06723769
This is a randomized controlled trial to evaluate the efficacy and safety of Low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) in post-stroke depression (PSD), explore mechanism of rTMS with Functional near-infrared spectroscopy (fNIRS).
NCT04318951
The present parallel-group, single-center, blinded-assessment controlled trial seeks to explore the feasibility - in terms of high completion rates - and potential efficacy of intensive communicative-pragmatic social interaction for treatment of post stroke depression in subacute aphasia. Apart from evidence of treatment feasibility, the primary hypothesis predicts significantly greater progress on self-report and clinician-rated measures of depression severity after (i) intensive communicative-pragmatic social interaction combined with standard care, compared to (ii) standard care alone.
NCT02585349
Stroke is a leading cause of disability, affecting about 34,000 to 41,000 individuals in the Netherlands of middle and old age every year. Due to the aging of the population, this figure will increase considerably over the next decades (Struijs et al., 2005). Twenty-five percent of stroke patients die within one month, making stroke a major risk factor for premature death in developed countries. According to the World Health Organization, stroke is the third leading cause of the burden of disease in middle and high-income countries (World Health Organization, 2008). It has a significant negative impact on quality of life of both the patients as well as their caregivers and significant others. Surviving stroke patients often struggle with its manifold and lifelong lasting consequences, with 35 percent of patients being functionally dependent one year after stroke (Wolfe, 2000) and cognitive and emotional changes which are found up to two years post-stroke (Rasquin, Lodder, \& Verhey, 2005). Depression, apathy, and cognitive impairment are very prevalent and significantly contribute to the burden of the disease, but their etiologies remain poorly understood. The aim of the CASPER study is to gain more insight into the etiologies of post-stroke depression (PSD), post-stroke apathy (PSA), vascular cognitive impairment (VCI), and post-stroke dementia. Therefore, the primary objectives are to identify biomarker-based predictors of PSD, PSA, and VCI. A secondary aim is to study effect modulation, especially the interaction between cerebrovascular disease, neurodegenerative changes and inflammation in post-stroke dementia. CASPER is a prospective clinical cohort study of 250 first-ever ischemic stroke patients with serial assessments at baseline (10 to 12 weeks after stroke), six and 12 months after baseline. Another wave (36 month after baseline) was later added.
NCT03789994
This mixed-method study includes a randomised controlled trial and an exploratory qualitative study, and aims to examine the effects of caregiver-delivered affective touch on depressive symptoms, state of attachment security, self-esteem, and perceived family harmony among stroke survivors, and to explore the mediating effect of attachment security and how an intervention may affect depressive symptoms from stroke survivor's perspective. A total of 184 survivor-caregiver dyads will be recruited from various non-governmental organisations. The dyads will be randomly allocated to intervention (IG) and control (CG) groups, stratified by the survivor's attachment style. IG caregivers will be taught to deliver a 15-minute affective touch intervention to stroke survivors. To address the attention effect, CG caregivers will be asked to sit with the survivors during a 15-minute fine motor coordination exercise. Both activities, affective touching and fine motor exercise, will be performed for 12 weeks (3 times/week), and the outcomes mentioned earlier will be measured at baseline, 12 and 36 weeks after study entry.
NCT04093843
The purpose of this study is to find alternative treatments for patient's suffering from depression after having a stroke.This study aims to show that accelerated rTMS is a safe, effective,and convenient treatment for patient's suffering from post-stroke depression in the acute to subacute phase. This will be an open label trial and thus all participants will receive the active rTMS intervention.
NCT05241782
Heart rate variability (HRV) in post-stroke patients are closely related to patient mortality, neurological deterioration and overall prognosis. Anxiety and depression will demotivate the patients' will to undergo rehabilitation program, which would delay their functional recovery. The influence of acupressure over the auricle on the HRV, anxiousness and depressive mood have yet to be verified. The investigators aimed to study the effect on auricular acupressure treatment between the different trending of HRV, anxiety and depression and their correlations. This is a randomized control study, consisted of 70 patients with post-stroke depressive mood, from both CGH and Xizhi Cathay hospital in Taiwan. HRV analysis is performed on the first 24 hours, and on a weekly basis for a total of 6 weeks. The included depressed patients were defined by the "Hospital Anxiety and Depression Scale" and weekly will be undertaken by the patients. A "Taiwanese Depression Questionnaire" pre-test and after-test will be undertaken by the patients. Experimental group will receive acupressure treatment by the second week, trice daily, 3\~5minutes each session for a course of four weeks. Data were analyzed using SPSS 20.0, using generalized estimating equation, GEE. The study hypothesized that the auricular acupressure treatment would improve post-stroke depression. Therefore, participants would be more willing to receive rehabilitation program. Our study would also help to provide future references on related studies.
NCT03639259
Fatigue is a prevalent, prolonged and partly disabling symptom following cerebral stroke. The health services has little knowledge of fatigue, both in terms of what characterizes those affected, and with regard to how fatigue can be treated. Persons going through a stroke may experience impairments in cognitive functions such as attention and memory. This will often cause previously effortless activities of daily living to become strenuous and exhausting. Experiencing a stroke will also in many cases lead to a major change in life due to other related loss of function, grief and health-related concerns. Emotional reactions like depression and anxiety are widespread. Specific knowledge of how cognitive impairment, emotional reactions and coping strategies contribute to development and maintenance of fatigue is lacking. The present research project will contribute with new and important knowledge in this area. A total of 250 adults have been followed up after stroke with multiple examinations. Average age at the time of stroke was 70 years. The investigators now plan to follow them up three to four years after stroke. This provides a unique opportunity to investigate how depression and anxiety, over time, may be related to the experience of fatigue, cognitive impairment and negative coping strategies such as worrying and rumination. The investigators will use questionnaires and cognitive tests when examining these associations. Such new knowledge about cognitive and emotional factors related to the development of fatigue long-term after stroke may help determine who is at risk of developing symptoms of fatigue. Furthermore, it can shed light on possible preventional measures, and provide better suited advice to those affected by fatigue. This knowledge can also pave the way for new, research-based treatment methods.
NCT04008719
The purpose of this study is to determine whether cognitive function evaluation (sustained attention, executive functions, working memory) during acute post-stroke is predictive of a 3 months post-stroke depression.
NCT03335358
This study aims to pilot test an 8-week, self-administered dyadic (couples-based) positive psychology intervention for couples coping with stroke using a randomized, waitlist control design. Mood and well-being will be assessed pre- and post-intervention, and at 3-month follow-up. It is expected that both partners will demonstrate improvement in mood and well-being.
NCT03903068
Post-stroke depression (PSD) is one of the most common complications after stroke, with a high prevalence. PSD can affect prognosis and rehabilitation of stroke, increase risks of mortality and suicide, and escalate the economic burden on individuals and society. Studies have shown that transcranial alternating current stimulation (tACS) can also be used to treat depression, insomnia and anxiety. So far, this stimulator has been approved by FDA. However, there have not been any reports on the use of tACS in the treatment of depression and PSD in China. In this trial, the efficacy and safety of the tACS will be assessed with the rigor methodology manner.
NCT03159351
This is a multicenter, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness of repetitive transcranial magnetic stimulation(rTMS) in treating depression after basal ganglia ischemic stroke and to examine whether such effects are related to restoration of white matter integrity.Sixty-six participants will be recruited from three centers and randomized with a 1:1 ratio to receive active rTMS treatment or sham rTMS treatment in addition to routine supportive treatments.The data of neuropsychological tests and MRI will be collected at 0, 2 and 4 weeks after the commencement of the treatment.