ANZCTR search results

Freezing of gait commonly affects people with Parkinson’s disease and is known to impair mobility, increase falls risks, and reduce quality of life. The pathophysiology behind freezing of gait remains poorly understood but there is growing evidence to suggest a complex relationship between motor and non-motor factors such as cognition, mood, and environment. Pharmacological treatment is commonly offered as an intervention for freezing of gait. However, freezing of gait may persist despite optimal pharmacological intervention, especially with increased disease duration and severity. Non-pharmacological and non-surgical interventions for freezing of gait such as action observation show promise as an effective intervention to reduce freezing of gait. To date, the approach that has been tested involves: (i) the person with FOG watching video clips of an actor (without Parkinson’s disease) performing generic movement strategies to reduce freezing of gait in a clinical setting, followed by (ii) physically practising the movement strategies. The intervention that is proposed in this study is a 180 degree video self-modelling intervention using an immersive virtual reality headset, whereby the person with Parkinson’s disease observes videos of his/her own best movement strategies for preventing or overcoming freezing of gait, performed in his/her own home environment. The personalised movement strategies will be based on assessment of the individual’s motor, cognitive, emotional and environmental FOG triggers and exploration of appropriate and acceptable movement strategies for the person by a trained physiotherapist. Participants will watch their videos repeatedly (while seated), with physical practice performed separately in the context of everyday tasks. This pilot study aims to determine the feasibility and acceptability of a video self-modelling intervention using an immersive virtual reality headset for managing freezing of gait in people with Parkinson’s disease. In addition, it will evaluate the impact of the intervention on freezing of gait and on movement strategies used during freezing of gait testing. The project will provide the proof-of-concept evidence required to secure large grant funding for a randomised controlled trial to evaluate the effectiveness of the intervention.

The daily light and dark cycle is the strongest external time cue for humans to maintain circadian rhythmicity via a specialised endogenous network. Impairment of the circadian rhythm has been shown to occur more commonly with advancing age and diminished health and as such has led to a higher prevalence of sleep disorders in the older population. Nonpharmacological strategies to treat sleep and circadian disruptions have been explored. One of these strategies being explored in this research proposal is the use of light therapy (LT). Evidence shows that LT can improve sleep consolidation, decrease daytime sleepiness and napping, realign desynchronised circadian rhythms and improve cognition. In fact, it has been shown that short wavelength light increases alertness while longer wavelength light promotes sleep. However, no research has tested LT of varying wavelengths during the day over an extended period and whether timed exposure can lead to a greater level of improvement in sleep and cognition. The study aims to demonstrate that timed exposure to a LT condition of variable wavelength for 4 days (short wavelength enriched in the day and short wavelength-attenuated in the evening) can improve sleep, mood and cognition as well as reverse melatonin suppression when compared to a control lighting condition (white light). Participants older than 50 years with self-reported poor sleep will reside, on two separate occasions, for 4 consecutive days at the Woolcock Institute in one of our research laboratory suites. Polysomnography, high density and routine electroencephalography tests will be conducted to assess sleep and brain activity and determine the primary endpoint of Wake time After Sleep Onset (WASO). Extensive neurocognitive testing using standardised questionnaires and computerised tests will occur during the study to assess cognition and used as secondary endpoints. Overall, the study will allow us to ascertain whether manipulating the spectrum and timing of light exposure can optimise nocturnal sleep, daytime alertness and improve overall quality of life.

The ActiPatch is a small battery powered device that produces a very small electromagnetic field that you cannot feel but which early studies have found to be effective in some pain conditions. Our study aims to test what effects using this device has on pain in chronic low back pain and other aspects of the chronic pain experience. This will assist with knowing recommendations we should make to our patients about this device and how and when we might use it. As the device is relatively new on the market you would normally need to purchase this device so you will have the opportunity to trial this device at no cost to you.

Females experience fluctuating steroid hormone profiles throughout their menstrual cycle. During the early follicular (EF) phase, characterised by the onset of bleeding, concentrations of both oestrogen and progesterone are low. Oestrogen increases, and then peaks in the late follicular (LF) phase just prior to ovulation before dropping and then increasing again during the mid-luteal (ML) phase (although not to the same concentrations as seen in the LF phase). Progesterone increases after ovulation, peaking during the ML phase and then decreasing prior to the next EF phase. There is some evidence that females tolerate gut ischemia (i.e. a lack of oxygen in the gut, often due to blood loss in circumstances such as trauma) better than males. It has been suggested that this is attributable to the protective effects of oestrogen. Interestingly, endurance exercise also causes reduced blood flow (and therefore oxygen) to the gut because blood is redistributed to the working muscles. After an hour of running at 70% of VO2 max blood flow has been shown to be reduced by 80% causing small intestinal injury similar to that induced by trauma. However, to date no study has looked at the menstrual cycle in humans in relation to changes in gut integrity in response to exercise. The aim of this study is to provide preliminary data on the potential sex dimorphism in susceptibility to intestinal damage during endurance exercise, and if this damage is menstrual cycle dependent. If differences are found, this may have implications for female athletes training and racing during different phases of their menstrual cycle.

Methamphetamine use is of deep concern in Aboriginal and Torres Strait Islander communities but access to culturally appropriate treatment resources and services is limited. The 'We Can Do This' web-based therapeutic intervention (WBTI) is designed to incorporate evidence-based therapies in a culturally-relevant format using narratives from Aboriginal people to contextualise the therapeutic content. The effectiveness of the WBTI will be tested in a wait-list control, randomised trial across multiple sites in urban, regional and remote locations. Participants will be Aboriginal and Torres Strait Islander people aged 16 or over recruited online and via health services. The primary outcome measure will be the number of days when the participant used methamphetamine during the treatment phase. Secondary outcomes will include readiness to change, help-seeking, severity of dependence, psychological distress and health service access. Assessment will occur at baseline, 1 month, 2 months and 3 months. If successful, the ‘We Can Do this’ WBTI will increase the range of options available to Aboriginal people seeking to reduce or stop methamphetamine use. It will provide health practitioners with a culturally-appropriate, evidence-based resource to use with clients, and may provide a pathway into treatment for people who may otherwise be disengaged with health services for a range of reasons.

Minor stroke is a stroke that leads to minimal motor deficits and/or no obvious sensory abnormality. Milder post-stroke impairments are often hidden in the supported hospital environment, instead manifesting only when the patients have returned home and attempt to resume their everyday activities. Despite the high incidence of minor stroke in Australia and the personal and societal impact of ongoing limitations in functioning, there is no established integrated care for managing minor stroke patients beyond hospital discharge. The primary aim of this project is to assess whether a new multi-component service pathway for minor stroke patients will reduce unmet need compared with usual care and 1 and 3 month’s post-hospital discharge.

A significant proportion of cochlear implant recipients lose all residual, natural hearing immediately after the surgery. The aim of this trial is to test the use of electrocochleography measured during implantation to estimate cochlear health, to predict the preservation of residual hearing. Patients will be followed up for 12 months after surgery.

Giant Cell Arteritis (GCA) is a condition of inflammation of blood vessels which commonly affects the blood supply to the eyes. Left undetected, GCA can rapidly cause irreversible blindness. Other potential complications include stroke, aortic dissection and death. Therefore, early diagnosis and intervention is imperative. Traditionally, diagnosis has relied on early suspicion of the disease, urgent review by a physician and an ophthalmologist, along with a surgical procedure (temporal artery biopsy). Following diagnosis of the disease, prompt treatment with potent immune suppressant medication is required. Biopsies are a relatively expensive procedure with a low positive yield. Additionally, biopsies can often take weeks to organise, but treatment needs to be given relatively urgently, so delay in obtaining biopsy means that diagnosis can be obscured by the treatment. Better ways of screening and managing patients are needed. Recently, international models of care have recommended an alternative approach to deliver assessment and care for GCA through “Fast Track” GCA Clinics, which have demonstrated improved outcomes for patients. These are collaborative clinics between rheumatologists and ophthalmologists that provide clinical review followed by assessment using ultrasound imaging of the arteries instead of biopsy. This approach avoids hospital admission but produces quick, accessible and reliable diagnostic yield and only a subgroup will require progression to biopsy. Fast Track GCA Clinics have not yet been implemented in the Australian health care setting. We aim to establish a collaborative Fast Track GCA Clinic in Western Australia and demonstrate direct health care savings, validity of ultrasound at the primary diagnostic tool over temporal artery biopsy, improved clinical outcomes for patients, and further the research agenda in this relatively common, potentially devastating, but treatable condition.

Open heart surgery saves thousands of lives each year in Australia, but often injures the kidney. Kidney oxygen deficiency is a major cause of kidney injury. We propose a new way to prevent acute kidney injury by increasing kidney oxygen levels during heart surgery. The aim of this trial is to determine whether this new approach to prevention of kidney injury is safe, feasible and effective.

This study represents a first-in-human clinical trial for ZY-19489 and aims to determine the safety, tolerability and pharmacokinetics activity of the drug when administered to healthy human subjects. The study will be conducted in three parts. This registration is for Part 1. Part 1 will be a single ascending dose) study which will provide information on the safety, tolerability and pharmacokinetic profile of different single oral doses of ZY-19489 administered to fasted subjects. It will be conducted in up to 7 cohorts of 8 subjects each. Each cohort will be enrolled within a 28 day screening period to ensure subjects meet all the inclusion criteria and none of the exclusion criteria. Subjects will be randomised within each cohort to receive a single oral dose of ZY-19489 or placebo on Day 0 after an overnight fast of at least 10 hours in a ratio of 6:2. A sentinel dosing strategy will be employed for each dose cohort. Two sentinel subjects (one subject randomised to ZY-19489 and the other subject randomised to placebo) will be dosed and a review of the blinded safety data obtained up to 48 hours post-dosing will be conducted by the Investigator. If no safety concerns are identified, the remaining 6 subjects of the cohort will be dosed (5 subjects randomised to ZY-19489 and 1 subject randomised to placebo). Adverse events and concomitant medications will be followed throughout the study. The study will be over-sighted by Principal Investigator, Dr James McCarthy, an Infectious Diseases physician experienced in the conduct of malaria challenge studies.