What are the symptom trajectories of self-regulatory fatigue among family caregivers of stroke survivors? A protocol of mixed-methods study in Chinese rehabilitation settings

Introduction
Stroke presents a considerable burden not only to patients but also to their families and society at large. In many instances, stroke patients opt for home rehabilitation, relying on family caregivers for daily assistance. This dynamic significantly influences the physiological, psychological and social well-being of these caregivers. Despite its importance, the phenomenon of self-regulatory fatigue (SRF) among family caregivers has received insufficient attention in the literature. Therefore, the objective of this study is to investigate the levels of SRF, the characteristics of associated symptoms and the trajectories of symptom change experienced by family caregivers of stroke patients.

Methods and analysis
This research employs a mixed-methods approach, combining a cross-sectional study with a prospective longitudinal quantitative and qualitative design. The Chinese version of the SRF Scale and the Chinese version of Patient-Reported Outcomes Measurement Information System profile-29 are used to assess SRF, psychological and physiological symptoms, and related functional outcomes among family caregivers of stroke patients. Latent class growth analysis will be employed to model the heterogeneous developmental trajectories of SRF-related symptoms among family caregivers of stroke patients. Reflexive thematic analysis will be employed to analyse, organise and summarise qualitative data, to identify the experiences and management needs related to SRF among family caregivers during home care. Through this comprehensive mixed-methods approach, the study aims to: investigate the levels of SRF experienced by family caregivers of stroke patients, identify patterns and trajectories of related symptoms. The integration of cross-sectional and longitudinal data allows for a thorough examination of both immediate and long-term aspects of caregiver experiences, providing valuable insights into the complex dynamics of SRF in this population.

Ethics and dissemination
The study protocol was approved by the Medical Ethics Committee of the University of South China (approval number 2023-NHHL-051). Data collection was authorised by the ethics committees of the First Affiliated Hospital, Second Affiliated Hospital and Nanhua Affiliated Hospital of the University of South China. The results of this study will be disseminated through publication in pertinent peer-reviewed journals, presentation at local and international conferences, and communication with all relevant stakeholders.

Trial registration number
ChiCTR2400082717.

Leggi
Marzo 2025

Does the alternating timing of rTMS combined with soft-hand rehabilitation robot affect the recovery of hand function in patients after stroke? A study protocol for a multicentre randomised controlled trial

Introduction
Combining repetitive transcranial magnetic stimulation (rTMS) with robotic training could result in more significant improvements in motor function than either treatment alone. The efficacy of this combination may depend on the sequencing of the interventions. However, few studies have explored the possibility of interleaving or alternating between the two treatment modalities within a single session or over a shorter time frame. The objective of this study is to evaluate the efficacy of alternating rTMS and soft-hand rehabilitation robot therapy to enhance upper limb and hand function in patients with ischaemic stroke.

Methods and analysis
This multicentre study will be conducted as a single-blind, controlled, randomised trial, enrolling 132 post-stroke patients with a disease duration ranging from 1 week to 3 months. The study participants will be randomly assigned to group A (n=44), group B (n=44) and group C (n=44). All participants will undergo a 4-week neurological rehabilitation programme, which includes standardised physical and occupational therapy administered by experienced therapists. Group A will receive 10 Hz high-frequency rTMS (HF-rTMS) over the ipsilesional primary motor cortex (iM1) for 20 min, followed by 20 min of soft-hand rehabilitation robot training. Group B will receive 5 min of 10 Hz HF-rTMS over the iM1 followed by 5 min of soft-hand rehabilitation robot training, repeated four times. Group C will receive sham rTMS with other parameters identical to those of group A. The above treatments will be administered once daily, 5 days a week, for 4 weeks. The primary outcome measurement is the Fugl-Meyer assessment of upper extremity (FMA-UE). The secondary outcome measurements include the Hong Kong edition of Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK), the Modified Ashworth Scale (MAS), and the International Classification of Functioning, Disability and Health upper extremity entries (ICF-Upper Extremity Entries). Assessments will be conducted at baseline and after 4 weeks of treatment.

Ethics and dissemination
This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (2024-SR-515). The findings of this study will be spread through networks of scientists, professionals and the general public, as well as peer-reviewed scientific papers and presentations at pertinent conferences.

Trial registration number
ChiCTR2400089583.

Leggi
Marzo 2025

Effect of electroacupuncture on the incidence of acute stroke after embolisation of intracranial aneurysm: study protocol for a single-centre, double-blinded, randomised controlled trial

Background
Electroacupuncture (EA) is commonly used in clinical settings as a significant method for treating a variety of pain and cerebrovascular disorders. Despite its widespread use, there is limited information on the impact of perioperative EA on postoperative stroke. This study aimed to investigate whether preoperative EA therapy could reduce the occurrence of acute stroke in patients undergoing interventional surgery for intracranial aneurysms.

Methods/design
This single-centre, double-blind, placebo-controlled, randomised clinical trial aims to recruit 280 patients undergoing embolisation of intracranial aneurysms under general anaesthesia. Participants will be randomly assigned to either the EA group or sham electroacupuncture (SEA) group. The EA group will receive treatment half an hour before surgery, while the SEA group will receive sham acupuncture. The primary outcome will be the occurrence of acute stroke within 7 days post surgery. Secondary outcomes include the incidence of symptomatic and occult stroke within the same timeframe, the occurrence of cerebral vasospasm during the operation and the number of intraoperative cerebrovascular dissections.

Ethics and dissemination
This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (2023-SR-538.A1). The study started on 17 May 2024, and it is expected to end on 31 March 2025. The results of our study will be published in peer-reviewed journals.

Trial registration number
ChiCTR2300076960.

Leggi
Marzo 2025

Acute-Phase Recording of the Spreading Depolarization Continuum in Aged Nonhuman Primates During Focal Ischemic Stroke

Stroke, Ahead of Print. BACKGROUND:Decades of experimental and clinical data revealed that spreading depolarizations (SDs) play a central causal role in the development of cortical lesions after acute brain injury. However, clinical documentation of events at the onset of focal ischemic stroke and during the initial phase of cortical injury development is lacking because electroencephalography monitoring of SD typically starts hours or days later. Here, we used nonhuman primates to map electrophysiological pathology through focal ischemic stroke’s onset and acute stage.METHODS:Craniotomies were performed over both hemispheres on 4 male and 1 female nemestrina and rhesus macaques aged 23 years to 32 years. Subdural electrode arrays were placed bilaterally over the middle cerebral artery territory, recording from 24 electrodes 1 cm apart on the left cortex and 7 on the right. After 30 minutes of baseline monitoring, the left middle cerebral artery and, in some cases, also the left internal carotid or anterior cerebral arteries were permanently occluded with aneurysmal clips.RESULTS:Repetitive SDs occurred during the next 3 hours, followed by terminal SD during euthanasia. No epileptiform activity was observed in any of the 5 animals. Nonspreading electrical silence developed in the ischemic core within seconds of ischemic onset, followed by terminal SD and SD-initiated negative ultraslow potential after several minutes. These events defined the ischemic core and led to histologically confirmed cell damage. Initial and subsequent transient SDs caused spreading depression of spontaneous activity in the normally perfused surrounding cortex without any signs of histological damage. Cardiocirculatory arrest at the end of experiments first induced nonspreading depression of activity followed by SD and, eventually, the SD-initiated negative ultraslow potential, which indicated brain death.CONCLUSIONS:Results in gyrencephalic nonhuman primates hold significant implications for understanding the role of SD in acute brain injury development and for the clinical translation and diagnosis of pathologies manifested in the SD continuum.

Leggi
Febbraio 2025

Correction: Intra-arterial alteplase for acute ischaemic stroke after mechanical thrombectomy (PEARL): rationale and design of a multicentre, prospective, open-label, blinded-endpoint, randomised controlled trial

Yang X, He X, Pan D, et al. Intra-arterial alteplase for acute ischaemic stroke after mechanical thrombectomy (PEARL): rationale and design of a multicentre, prospective, open-label, blinded-endpoint, randomised controlled trial. BMJ Open 2024;14:e091059. doi: 10.1136/bmjopen-2024091059 This article was previously published with an error. The follow-up visit at ‘48±12 hours’ was inadvertently omitted from ‘Follow-up Procedures’ under the Methods section. To accurately reflect all key assessment points, the text has been updated to: Study visits will occur at 24±12 hours, 48±12 hours, day 7±1 or at discharge (whichever occurs first), and day 90±7. The follow-up schedule is displayed in table 1. Accordingly, table 1 has been updated to include the missing ‘48±12 hours after randomisation’ visit, during which NIHSS scores, adverse event monitoring, and concomitant medication use are documented. The missing ‘48±12 hours’ follow-up visit has also been added to the timeline in figure 2, to align with…

Leggi
Febbraio 2025

Acute Intermittent Hypoxia in People Living With Chronic Stroke: A Case Series

Stroke, Ahead of Print. BACKGROUND:Acute intermittent hypoxia (AIH) is a novel therapeutic intervention that facilitates recovery of function, but the tolerability and effectiveness have not been tested in people living with chronic stroke. The purpose here was to examine whether AIH is tolerable and effective in this population.METHODS:Ten participants with a unilateral, hemispheric stroke were assessed before and after 4 sessions of AIH separated by ≥48 hours in a case series at Shirley Ryan AbilityLab (Chicago). Physician-assessed signs and symptoms (assessed via: repeated symptom reviews, National Institutes of Health Stroke Scale, cranial nerve assessment, a muscle strength test, the Brunnstrom scale, sensory changes, reflexes, assessment of heart and lung status, Fugl-Meyer test, Chedoke-McMaster Stroke Assessment, Modified Ashworth Scale for Spasticity, and Delis Kaplan Executive Function System Color-Word Interference Test) and bilateral upper limb strength (grip and elbow flexion) were assessed before, ≈15 to 30 minutes, and ≈60 minutes after the intervention.RESULTS:AIH was well-tolerated and there were no adverse events observed. After AIH, grip strength (12.91% and 16.53% improvement at 30 and 60 minutes post-AIH, respectively) and elbow flexion force (5.87% and 7.01% improvement at 30 and 60 minutes post-AIH, respectively) improved in the more-affected limb.CONCLUSIONS:AIH is potentially safe and effective for improving strength in the more-affected limb in people living with hemiparetic stroke. Future work should explore the use of AIH to enhance task-specific training-induced plasticity.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT04019522.

Leggi
Febbraio 2025

Impact of Conventional Stroke Risk Factors on Early- and Late-Onset Ischemic Stroke: A Mendelian Randomization Study

Stroke, Volume 56, Issue 3, Page 640-648, March 1, 2025. BACKGROUND:Stroke incidence is decreasing in older ages but increasing in young adults. These divergent trends are at least partially attributable not only to diverging trends in stroke risk factors but may also be due to differences in the impact of stroke risk factors at different ages. To address this latter possibility, we used Mendelian randomization to assess differences in the association of stroke risk factors between early-onset ischemic stroke ([EOS]; onset 18–59 years) and late-onset ischemic stroke ([LOS]; onset ≥60 years).METHODS:We identified genetic variants from the GWAS Catalog for use as instrumental variables to proxy conventional stroke risk factors and then estimated the effects of these variants on risk factors in younger and older individuals in the UK Biobank. We then used these estimates to estimate the causal effects of stroke risk factors on EOS (n=6728 cases) and LOS (n=9272) cases from SiGN (Stroke Genetic Network) and the EOSC (Early-Onset Stroke Consortium). Lastly, we compared odds ratios between EOS and LOS, stratified by TOAST (Trial of ORG 10172 in Acute Stroke Treatment) subtypes, to determine if differences between estimates could be attributed to differences in stroke subtype distributions.RESULTS:EOS was associated with higher levels of body mass index, blood pressure, type 2 diabetes, and lower levels of HDL (high-density lipoprotein) cholesterol (allP≤0.002), whereas LOS was associated with higher levels of systolic blood pressure (P=0.0001). The causal effect of body mass index on stroke was significantly stronger for EOS than for LOS (odds ratio, 1.26 versus 1.03;P=0.008). After the subtype-stratified analysis, the difference in causal effect sizes between EOS and LOS for body mass index diminished and was no longer significant.CONCLUSIONS:These results support a causal relationship between body mass index, blood pressure, type 2 diabetes, and HDL cholesterol levels with EOS and blood pressure levels in LOS. Interventions that target these traits may reduce stroke risk.

Leggi
Febbraio 2025

Listening-in-noise difficulties following stroke: a scoping review protocol

Introduction
Across different populations, listening difficulties have been shown to adversely impact social interactions and work performance, and substantively contribute to poorer quality of life. Following a stroke, people also report listening difficulties in noisy, everyday environments such as cafes and workplaces. Despite the prevalence of these challenges, there is limited understanding of this issue, which means the listening needs of stroke survivors remain under-recognised and unmet. The aim of this scoping review is to map the breadth and depth of the existing literature on stroke survivors’ experiences of listening in noisy environments, encompassing qualitative descriptions and quantitative assessments of listening-in-noise abilities, to identify contributing factors, knowledge gaps and potential intervention strategies.

Methods and analysis
This protocol has been registered with the Open Science Framework (protocol number: 39TCA) and follows the Joanna Briggs Institute guidelines for scoping reviews. The protocol was developed by a multidisciplinary and multiprofessional team, led by a survivor of stroke and informed by additional patient input. A mixed-methods approach will be used to generate independent narrative summaries of qualitative and quantitative studies, followed by an integrated narrative of findings across data types. We will first conduct a comprehensive search using Medline, Embase, PsycInfo, Scopus, Cumulated Index in Nursing and Allied Health Literature and Web of Science databases in February 2025. Eligible studies will include stroke survivors as participants and focus on listening-in-noise experiences or abilities. Qualitative studies must explore personal experiences or perceptions related to listening in noisy environments, and quantitative studies must assess listening-in-noise performance. Studies addressing mediating factors, such as cognition, comorbidities (eg, hearing loss, aphasia), environmental factors and intervention strategies (eg, auditory training, assistive devices) will also be included. Two independent reviewers will assess the studies for eligibility. In cases of disagreement, a third reviewer will independently compare and resolve any discrepancies, ensuring a consensus is reached. This approach aims to minimise bias and enhance the validity of the review findings. The data extraction and synthesis will adhere to established guidelines, ensuring a robust and transparent analysis.

Ethics and dissemination
Ethical approval is not required as this review will analyse the existing literature. The results will be published in an open-access peer-reviewed journal and presented at local and international conferences. This dissemination strategy aims to reach a wide audience, including clinicians, researchers, policymakers and people with lived experience of stroke.

Trial registration number
Open Science Framework (https://osf.io; protocol number: 39TCA).

Leggi
Febbraio 2025

High-dose high-intensity Queen Square upper-limb rehabilitation for people with chronic stroke (INTENSIVE): protocol for a single-centre, randomised controlled trial

Introduction
There is currently insufficient high-quality evidence to make general recommendations about high-dose high-intensity upper-limb rehabilitation programmes. Here we describe a randomised controlled trial that will determine the efficacy of two forms of high-dose, high-intensity upper-limb rehabilitation provided in a rehabilitation unit setting.

Methods and analysis
Patients with moderate upper-limb impairment (n=105, at least 6 months after stroke) will be randomised to either (1) high-dose high-intensity conventional upper-limb rehabilitation, (2) high-dose high-intensity virtual reality-based upper-limb rehabilitation and (3) usual care (a waiting list control group). Groups 1 and 2 will receive a minimum of 45 hours of active time on task over 3 weeks. Outcome measures will be collected at (T1) baseline; (T2) immediately post intervention and (T3) 3 months after the intervention has finished. The primary outcome measure will be the Fugl-Meyer Upper Extremity Assessment at 3 months after the intervention. Secondary outcome measures will be clinical, kinematic and neurophysiological using transcranial magnetic stimulation and electroencephalography. Explanatory measures will include MRI-based markers for integrity of the corticospinal tract, dorsal column-medial lemniscal pathway, grey and white matter and lesion load. The aim is to detect a difference of 7.25 points on the Fugl-Meyer Upper Extremity Assessment between each treatment group and the waitlist control group, with a power of 0.9 and significance of 0.025 (to account for two primary analyses). Analysis of change in the primary and secondary outcome measures will be performed using mulitple regression analysis.

Ethics and dissemination
The study protocol (V.1) has been approved by the Wales Research Ethics Committee 2 Cardiff (Rec reference: 22/WA/0065) on 15 March 2022. All recruited participants will provide informed consent. Trial results will be disseminated through peer-reviewed publications, presentations at major stroke/neurorehabilitation conferences and outreach to relevant stakeholder communities.

Trial registration number
NCT05527262.

Leggi
Febbraio 2025

Underused Palliative Care Could Aid Stroke Survivors

Every year in the US, 800 000 people experience strokes, and although most survive, current treatment plans fail to adequately address their physical, emotional, psychosocial, and spiritual distress, according to a new scientific statement from the American Heart Association. Palliative care could aid in the quality of life for both patients and their families by helping during all stages of poststroke care, including adapting to functional changes, navigating complex health care systems, and preparing for death when necessary. However, such care is often underused.

Leggi
Febbraio 2025

Intra-Arterial Thrombolytics During Thrombectomy for Ischemic Stroke

An ever-increasing number of acute ischemic stroke patients are being treated with intra-arterial thrombectomy, which aims to remove an embolic occlusion from a major intracranial artery with a catheter-based device. However, despite its proven efficacy, more than half of all patients do not achieve a satisfactory outcome and remain functionally dependent despite successful reperfusion. Research groups around the world are studying the potential of adjunctive treatments to further improve patient outcomes after thrombectomy. These additions range from antiplatelet and antithrombotic agents during the procedure, which are likely harmful, to neuroprotective agents, which have not been proven effective in humans.

Leggi
Febbraio 2025