ANZCTR search results

A number of neurological disorders such as Parkinson’s disease (PD) are characterised by abnormal brain activity (e.g., unusually large numbers of brain cells (neurons) simultaneously active). A pattern of stimulation which has shown therapeutic benefit is called coordinated reset stimulation (CRS). CRS involves the administration of brief, electrical pulses to the body through multiple electrode contacts, with parameters designed specifically to “reset” the abnormal brain activity associated with disorders such as PD. However, CRS stimulation has mainly been applied to fingers. To address walking impairments in PD, stimulation to the feet would target more appropriate receptors. Our work on people without PD has shown that vibration applied to the feet generates a brain response as measured using electroencephalography (EEG, or brain electrical activity). The aim of this study is to investigate the effect of non-invasive peripheral stimulation to the feet, on gait impairments in PD. Stimulation will be in the form of vibration or mild electrical pulses applied to the feet.

Many individuals with a history of electroconvulsive therapy (ECT) report ongoing difficulties with memory. The current study aims to trial 2-weeks of self-guided online memory strategy training for adults with a history of ECT and memory concerns (N=50). The control group will receive a hand-out with written memory strategies. Tests of memory and self-report questionnaires of mood and memory functioning will be given online before and after the 2-week intervention period. It is anticipated that individuals who access the online memory strategy training will show more improvement in memory and better satisfaction with memory, than the individuals in the control group.

There are different surgical options for people with an ACL injury. The most common is reconstruction, which uses tissue from other parts of the body, such as the hamstrings, to act as a replacement. This is a successful operation but does involve damage to bones from drilling holes, removal of tissue from elsewhere in the body, and does not keep any of the torn ligament which has potentially useful nerve endings. Modern ACL repair (stitching) is relatively new and, despite clear potential, has not been fully evaluated. It remains unknown whether it confers any of the theoretical benefits. We aim to conduct a comparative study to find out which is the best technique, reconstructing the ligament or repairing it. The research question is: For patients with recent proximal ACL ruptures (where the ligament has pulled directly off the bone), is ACL repair superior to ACL reconstruction at 24 months post-surgery? This will be measured by a questionnaire relating to the knee called KOOS-4.

This study is a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of FSD202 in adult participants with musculoskeletal nociplastic pain associated with MCAS. The study will be conducted as a decentralized clinical trial. Participants who meet the eligibility criteria will be randomized remotely, via the IVRS system, to receive 300 mg FSD202 or a placebo orally twice daily for 56 days in a ratio of 2:1. The study design consists of up to 17 days screening period, up to 4 days for randomization and initial delivery of IP to participant’s home, a 56-day treatment period, and a 7-day follow-up period. Each participant will participate in the trial for up to 84 days. 1. The study aimes to evaluate the analgesic efficacy of FSD202 compared to placebo in participants with chronic widespread musculoskeletal nociplastic pain associated with Idiopathic Mast Cell Activation Syndrome/ Disorder (MCAS/MCAD).

This interventional pilot and feasibility study will use a multiphase mixed methods process and outcomes evaluation, reported in line with the CONSORT checklist. Prescriptions for Connection, a social prescribing program, will be co-designed and implemented in six Australian primary care practices and three council areas. Implementation outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance Framework. Qualitative data collection, via focus groups for health and social care providers and interviews for older people, will be based on the Consolidated Framework for Implementation Research to explore barriers and facilitators, and explain outcomes.

Chronic Obstructive Pulmonary Disease (COPD) is a severe condition causing millions of deaths annually, with late diagnosis and progressive lung damage making current treatments only symptomatic. The trial focuses on the pre-COPD phase, a critical period when lung function begins to decline but before permanent damage occurs, offering an opportunity for intervention. Inhaled Triple Therapy (fluticasone furoate, umeclidinium, and vilanterol) may slow lung function decline and prevent progression to COPD. This double-blind, randomized, placebo-controlled trial will involve 500 participants from the Tasmanian Longitudinal Health Study (TAHS) to evaluate the therapy's effectiveness and cost efficiency. If successful, this groundbreaking study could shift COPD management to prevention, reduce its global burden, and lay the foundation for future research and drug development.

Emestedastat was created to decrease the production of cortisol by the brain. This drug has been previously tested in nearly 400 people, including healthy adults and people with Alzheimer’s Disease and depression. The research project will test what the body does to emestedastat, such as how quickly it enters, moves through, and leaves the body. In particular, the research project will test if eating food has any effect on what happens to emestedastat in the body. If this and other clinical research projects are successful, the treatment being studied may be approved to treat people with Alzheimer’s Disease or depression in the future.

In children, protracted bacterial bronchitis (PBB) and chronic suppurative lung disease (CSLD) represent chronic respiratory diseases on an overlapping continuum that can progress to irreversible bronchiectasis. Early management, principally through appropriate antibiotic treatment can prevent progression of disease in many children. Airway clearance techniques, prescribed by a physiotherapist are used routinely in children with chronic respiratory disease, such as cystic fibrosis and bronchiectasis to aid in sputum removal and have been shown to improve health outcomes and mortality. Increasingly, these techniques are being used in children with PBB/CSLD. However, there is no current evidence that addition of airway clearance techniques is efficacious in this cohort. Therefore, the aim of this study is to determine if airway clearance, as an adjunct to antibiotic therapy is efficacious in children with PBB. That is, does the addition of airway clearance to standard care reduce the length of the exacerbation? Our study is a single site randomised controlled, parallel clinical trial. Participants will be randomised to standard care (antibiotic therapy) or standardised care plus airway clearance during exacerbations and for 1-week post cough resolution. The primary outcome will be the proportion of children with cough resolution by day-10. Secondary outcomes will be change in (measured via parent-proxy cough-related Quality of Life) PC-QoL scores from day 1 to day-10 and 28 (post commencement of antibiotic therapy), and time to next exacerbation. We hypothesise that addition of airway clearance will result in a greater proportion of children with cough-resolution at day-10, improved PC-QoL, and longer time to next exacerbation.

The “BRAVE-CHIP” pathway is a novel, multidisciplinary model of care designed to accelerate the transition of patients with rib fractures into virtual care through a combination of contemporary rib fracture management and the early utilisation of regional anaesthesia, via a serratus anterior plane block placed in the ED. The project aim is to study the introduction the “BRAVE-CHIP” pathway into Royal North Shore Hospital by assessing whether it can have an impact on hospital length of stay whilst preserving pain management and respiratory function for our patients with rib fractures.

The study aims to evaluate the safety and efficacy signals of AST 004 as an acute intervention in athletes who sustain a sports related concussion during match play on game day. Adverse events, blood protein biomarker improvement, and clinical improvement will be analysed and neuropsychological testing assessed.